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Sample records for affairs diabetes trial

  1. Rosiglitazone treatment and cardiovascular disease in the Veterans Affairs Diabetes Trial

    PubMed Central

    Florez, H; Reaven, P D; Bahn, G; Moritz, T; Warren, S; Marks, J; Reda, D; Duckworth, W; Abraira, C; Hayward, R; Emanuele, N

    2015-01-01

    Aims To evaluate the relationship between patterns of rosiglitazone use and cardiovascular (CV) outcomes in the Veterans Affairs Diabetes Trial (VADT). Methods Time-dependent survival analyses, case–control and 1 : 1 propensity matching approaches were used to examine the relationship between patterns of rosiglitazone use and CV outcomes in the VADT, a randomized controlled study that assessed the effect of intensive glycaemic control on CV outcomes in 1791 patients with type 2 diabetes (T2D) whose mean age was 60.4 ± 9 years. Participants were recruited between 1 December 2000 and 31 May 2003, and were followed for 5–7.5 years (median 5.6) with a final visit by 31 May 2008. Rosiglitazone (4 mg and 8 mg daily) was initiated per protocol in both the intensive-therapy and standard-therapy groups. Main outcomes included a composite CV outcome, CV death and myocardial infarction (MI). Results Both daily doses of rosiglitazone were associated with lower risk for the primary composite CV outcome [4 mg: hazard ratio (HR) 0.63, 95% confidence interval (CI) 0.49–0.81 and 8 mg: HR 0.60, 95% CI 0.49–0.75] after adjusting for demographic and clinical covariates. A reduction in CV death was also observed (HR 0.25, p < 0.001, for both 4 and 8 mg/day rosiglitazone); however, the effect on MI was less evident for 8 mg/day and not significant for 4 mg/day. Conclusions In older patients with T2D the use of rosiglitazone was associated with decreased risk of the primary CV composite outcome and CV death. Rosiglitazone use did not lead to a higher risk of MI. PMID:25964070

  2. The effect of intensive glucose lowering therapy among major racial/ethnic groups in the Veterans Affairs Diabetes Trial

    PubMed Central

    Saremi, Aramesh; Schwenke, Dawn C.; Bahn, Gideon; Ge, Ling; Emanuele, Nicholas; Reaven, Peter D.

    2014-01-01

    Objective To examine the effect of intensive glycemic control on cardiovascular disease events (CVD) among the major race/ethnic groups in a post-hoc analysis of the VADT. Materials and Methods Participants included 1111 non-Hispanic Whites, 307 Hispanics and 306 non-Hispanic Blacks randomized to intensive or standard glucose treatment in VADT. Multivariable Cox proportional hazards models were constructed to assess the effect of intensive glucose treatment on CVD events among race/ethnic groups. Results Mean age was 60.4 years and median follow-up was 5.6 years. By design, modifiable risk factors were managed equally well in both treatment arms and only differed modestly between race/ethnic groups. HbA1c decreased significantly from baseline with intensive glucose treatment in each race/ethnic group, with a trend for a greater response in Hispanics (P=0.02 for overall comparison between groups). Intensive glucose treatment was associated with reduced risk of CVD events for Hispanics but not for others (hazard ratios ranged from 0.54 to 0.75 for Hispanics whereas they were consistently close to 1 for others). Sensitivity analyses with different definitions of race/ethnicity or limited to individuals free of previous known CVD yielded similar results. Conclusions The results of these analyses support the hypothesis that race/ethnicity is worthy of consideration when tailoring intensive treatment for individuals with long-standing type 2 diabetes. However, additional studies are needed to confirm the findings of this post-hoc analysis. PMID:25456099

  3. DIABETES PREVENTION TRIAL TYPE 1

    EPA Science Inventory

    The Diabetes Prevention Trial--Type 1 (DPT-1) is a nationwide study to see if we can prevent or delay type 1 diabetes, also known as insulin-dependent diabetes. Nine medical centers and more than 350 clinics in the United States and Canada are taking part in the study.

  4. Veterans Affairs Research on Health Information Technologies for Diabetes Self-Management Support

    PubMed Central

    Piette, John D.; Kerr, Eve; Richardson, Caroline; Heisler, Michele

    2008-01-01

    Background Like many patients with diabetes, Department of Veterans Affairs (VA) patients frequently fall short of self-management goals and experience multiple barriers to self-care. Health information technologies (HITs) may provide the tools that patients need to manage their illness under the direction of their primary care team. Methods We describe several ongoing projects focused on HIT resources for self-management in VA. VA researchers are developing HITs that seek to bolster a variety of potential avenues for self-management support, including patients′ relationships with other patients, connections with their informal care networks, and communication with their health care teams. Results Veterans Affairs HIT research projects are developing services that can address the needs of patients with multiple challenges to disease self-care, including multimorbidity, health literacy deficits, and limited treatment access. These services include patient-to-patient interactive voice response (IVR) calling systems, IVR assessments with feedback to informal caregivers, novel information supports for clinical pharmacists based on medication refill data, and enhanced pedometers. Conclusion Large health care systems such as the VA can play a critical role in developing HITs for diabetes self-care. To be truly effective, these efforts should include a continuum of studies: observational research to identify barriers to self-management, developmental studies (e.g., usability testing), efficacy trials, and implementation studies to evaluate utility in real-world settings. VA HIT researchers partner with operations to promote the dissemination of efficacious services, and such relationships will be critical to move HIT innovations into practice. PMID:19885173

  5. Assessment of diabetic teleretinal imaging program at the Portland Department of Veterans Affairs Medical Center.

    PubMed

    Tsan, Grace L; Hoban, Keely L; Jun, Weon; Riedel, Kevin J; Pedersen, Amy L; Hayes, John

    2015-01-01

    We conducted a retrospective chart review of 200 diabetic patients who had teleretinal imaging performed between January 1, 2010, and January 1, 2011, at Portland Department of Veterans Affairs (VA) Medical Center outpatient clinics to assess the effectiveness of the diabetic teleretinal imaging program. Twenty patients (10%) had diabetic retinopathy. Ninety percent of the available teleretinal imaging studies were of adequate quality for interpretation. In accordance with local VA policy at that time, all teleretinal imaging patients should have been referred for a dilated retinal examination the following year. Image readers referred 97.5% of the patients to eye clinics for subsequent eye examinations, but the imagers scheduled appointments for only 80% of these patients. The redundancy rate, i.e., patients who had an eye examination within the past 6 mo, was 11%; the duplicate recall rate, i.e., patients who had a second teleretinal imaging performed within 1 yr of the eye examination, was 37%. Rates of timely diabetic eye examinations at clinics with teleretinal imaging programs, particularly when teleretinal imaging and eye clinics were colocated at the same community-based outpatient clinic, were higher than those without a teleretinal imaging program. We concluded that the Portland VA Medical Center's teleretinal imaging program was successful in increasing the screening rate for diabetic retinopathy. PMID:26230276

  6. The Violence Against Women Act on Trial: A Student Affairs Professional's Guide to the Issues.

    ERIC Educational Resources Information Center

    Goree, Cathryn T.; Holford, Elyzabeth J.

    1997-01-01

    Reviews legal issues surrounding the constitutionality of the Violence Against Women Act, which is currently being tested in federal courts. Provides background information for judicial officers, policymakers, health educators, women's advocates, and student affairs professionals who work regularly with women students. (Author/MKA)

  7. On jumbo and junkie trials: a fumbled affair, a jungle, or the ultimate solution?

    PubMed

    Hugenholtz, P G

    1991-12-01

    Important Clinical trials conducted between 1980 and 1990 provided early leads to the community of practicing cardiologists and general physicians on the fundamentals of the therapy of acute myocardial infarction. On the other hand trials like ISIS-III or GUSTO, the current giant among jumbo trials, could not solve the real problems arising in clinical practice. The large-scale clinical trials should be reserved for interventions that have been shown convincingly in smaller trials. The problem of restenosis after PTCA is discussed and the place of animal research is emphasized as the basis of the design of future clinical trials. These exciting data require a human study but with a scale that proves the efficacy of the intervention and substantiates the underlying hypothesis even in a small population. PMID:1805527

  8. Diabetes Self-Management Smartphone Application for Adults With Type 1 Diabetes: Randomized Controlled Trial

    PubMed Central

    Vandelanotte, Corneel; Fenning, Andrew; Duncan, Mitch J

    2013-01-01

    Background Persistently poor glycemic control in adult type 1 diabetes patients is a common, complex, and serious problem initiating significant damage to the cardiovascular, renal, neural, and visual systems. Currently, there is a plethora of low-cost and free diabetes self-management smartphone applications available in online stores. Objective The aim of this study was to examine the effectiveness of a freely available smartphone application combined with text-message feedback from a certified diabetes educator to improve glycemic control and other diabetes-related outcomes in adult patients with type 1 diabetes in a two-group randomized controlled trial. Methods Patients were recruited through an online type 1 diabetes support group and letters mailed to adults with type 1 diabetes throughout Australia. In a 6-month intervention, followed by a three-month follow-up, patients (n=72) were randomized to usual care (control group) or usual care and the use of a smartphone application (Glucose Buddy) with weekly text-message feedback from a Certified Diabetes Educator (intervention group). All outcome measures were collected at baseline and every three months over the study period. Patients’ glycosylated hemoglobin levels (HbA1c) were measured with a blood test and diabetes-related self-efficacy, self-care activities, and quality of life were measured with online questionnaires. Results The mean age of patients was 35.20 years (SD 10.43) (28 male, 44 female), 39% (28/72) were male, and patients had been diagnosed with type 1 diabetes for a mean of 18.94 years (SD 9.66). Of the initial 72 patients, 53 completed the study (25 intervention, 28 control group). The intervention group significantly improved glycemic control (HbA1c) from baseline (mean 9.08%, SD 1.18) to 9-month follow-up (mean 7.80%, SD 0.75), compared to the control group (baseline: mean 8.47%, SD 0.86, follow-up: mean 8.58%, SD 1.16). No significant change over time was found in either group in

  9. Action for Health in Diabetes (Look AHEAD) Trial

    PubMed Central

    Vitolins, Mara Z.; Anderson, Andrea M.; Delahanty, Linda; Raynor, Hollie; Miller, Gary D.; Mobley, Connie; Reeves, Rebecca; Yamamoto, Monica; Champagne, Catherine; Wing, Rena R.; Mayer-Davis, Elizabeth

    2009-01-01

    Background Little has been reported regarding food and nutrient intake in persons diagnosed with type 2 diabetes and most reports have been based on findings in select groups or persons who self-reported having diabetes. Objective To describe the baseline food and nutrient intake of the Look AHEAD trial participants, compare participant intake to national guidelines, and describe demographic and health characteristics associated with food group consumption. Methods The Look AHEAD trial is evaluating the effects of a lifestyle intervention (calorie control and increased physical activity for weight loss) compared to diabetes support and education on long-term cardiovascular and other health outcomes. Participants are 45-75 years old, overweight or obese [Body Mass Index (BMI) ≥ 25 kg/m2], and have type 2 diabetes. Baseline food consumption was assessed in 2,757 participants between September 2000 and December 2003 by food frequency questionnaire in this cross-sectional analysis. Statistical Analysis Descriptive statistics were used to summarize intake by demographic characteristics. Kruskal-Wallis tests assessed univariate effects of characteristics on consumption. Multiple linear regression models assessed factors predictive of intake. Least square estimates were based on final models and logistic regression determined factors predictive of recommended intake. Results Ninety-three percent of the participants exceeded the recommended amount of percent calories from fat, 85 % exceeded the saturated fat recommendation, and 92% consumed too much sodium. Also, less than half met the minimum recommended servings of fruit, vegetables, dairy, and grains. Conclusions These participants with pre-existing diabetes fell short of consuming foods that met recommended food and nutrition guidelines. These overweight adults diagnosed with diabetes are exceeding recommended intake of fat, saturated fats, and sodium which may contribute to increasing their risk of cardiovascular

  10. Updates on the Clinical Trials in Diabetic Macular Edema

    PubMed Central

    Demirel, Sibel; Argo, Colby; Agarwal, Aniruddha; Parriott, Jacob; Sepah, Yasir Jamal; Do, Diana V.; Nguyen, Quan Dong

    2016-01-01

    In this era of evidence-based medicine, significant progress has been made in the field of pharmacotherapeutics for the management of diabetic macular edema (DME). A. number of landmark clinical trials have provided strong evidence of the safety and efficacy of agents such as anti-vascular endothelial growth factors for the treatment of DME. Decades of clinical research, ranging from the early treatment of diabetic retinopathy study to the present-day randomized clinical trials (RCTs) testing novel agents, have shifted the goal of therapy from preventing vision loss to ensuring a maximum visual gain. Systematic study designs have provided robust data with an attempt to optimize the treatment regimens including the choice of the agent and timing of therapy. However, due to a number of challenges in the management of DME with approved agents, further studies are needed. For the purpose of this review, an extensive database search in English language was performed to identify prospective, RCTs testing pharmacological agents for DME. In order to acquaint the reader with the most relevant data from these clinical trials, this review focuses on pharmacological agents that are currently approved or have widespread applications in the management of DME. An update on clinical trials presently underway for DME has also been provided. PMID:26957834

  11. Strategies for clinical trials in type 1 diabetes.

    PubMed

    Ehlers, Mario R

    2016-07-01

    During the past one to two decades, substantial progress has been made in our understanding of the immunopathology of type 1 diabetes (T1D) and the potential for immune interventions that can alter the natural history of the disease. This progress has resulted from the use of standardized study designs, endpoints, and, to a certain extent, mechanistic analyses in intervention trials in the setting of new-onset T1D. To date, most of these trials have involved single-agent interventions but, increasingly, future trials will test therapeutic combinations that are based on a compelling scientific rationale and testable mechanistic hypotheses. These increasingly complex trials will benefit from novel trial designs (such as factorial or adaptive designs), enhanced clinical endpoints that more directly assess islet pathology (such as β-cell death assays and islet or pancreatic imaging), improved responder analyses, and sophisticated mechanistic assays that provide deep phenotyping of lymphocyte subsets, gene expression profiling, in vitro T cell functional assessments, and antigen-specific responses. With this developing armamentarium of enhanced trial designs, endpoints, and clinical and mechanistic response analyses, we can expect substantial progress in better understanding the breakdown in immunologic tolerance in T1D and how to restore it to achieve significant and long-lasting preservation of islet function. PMID:27068279

  12. Trials in Prevention of Type 1 Diabetes: Current and Future

    PubMed Central

    Wherrett, Diane K.

    2014-01-01

    A major thrust in type 1 diabetes research is stopping the destruction of β cells that leads to type 1 diabetes. Research over the past thirty years has defined genetic factors and evidence of autoimmunity that have led to the development of robust prediction models in those at high risk of type 1 diabetes. The ability to identify those at risk and the development of new agents and of collaborative research networks has led to multiple trials aimed at preventing β cell loss. Trials at all stages of beta cell loss have been conducted: primary prevention - prior to the development of autoimmunity, secondary prevention – after autoantibodies are found, and tertiary prevention – intervening after diagnosis to maintain remaining β cells. Studies have shown mixed results with evidence of maintained insulin secretion after the time of diagnosis described in a number of studies and primary and secondary prevention proving to be elusive. Much has been learned from the increasing number of studies in the field in terms of network creation, study design and choice of intervention that will facilitate new avenues of investigation. PMID:25092646

  13. Robot-assisted upper-limb therapy in acute rehabilitation setting following stroke: Department of Veterans Affairs multisite clinical trial.

    PubMed

    Burgar, Charles G; Lum, Peter S; Scremin, A M Erika; Garber, Susan L; Van der Loos, H F Machiel; Kenney, Deborah; Shor, Peggy

    2011-01-01

    This randomized, controlled, multisite Department of Veterans Affairs clinical trial assessed robot-assisted (RA) upper-limb therapy with the Mirror Image Movement Enabler (MIME) in the acute stroke rehabilitation setting. Hemiparetic subjects (n = 54) received RA therapy using MIME for either up to 15 hours (low-dose) or 30 hours (high-dose) or received up to 15 hours of additional conventional therapy in addition to usual care (control). The primary outcome measure was the Fugl-Meyer Assessment (FMA). The secondary outcome measures were the Functional Independence Measure (FIM), Wolf Motor Function Test, Motor Power, and Ashworth scores at intake, discharge, and 6-month follow-up. Mean duration of study treatment was 8.6, 15.8, and 9.4 hours for the low-dose, high-dose, and control groups, respectively. Gains in the primary outcome measure were not significantly different between groups at follow-up. Significant correlations were found at discharge between FMA gains and the dose and intensity of RA. Intensity also correlated with FMA gain at 6 months. The high-dose group had greater FIM gains than controls at discharge and greater tone but no difference in FIM changes compared with low-dose subjects at 6 months. As used during acute rehabilitation, motor-control changes at follow-up were no less with MIME than with additional conventional therapy. Intensity of training with MIME was positively correlated with motor-control gains. PMID:21674393

  14. Statin Use and Its Facility-Level Variation in Patients With Diabetes: Insight From the Veterans Affairs National Database.

    PubMed

    Pokharel, Yashashwi; Akeroyd, Julia M; Ramsey, David J; Hira, Ravi S; Nambi, Vijay; Shah, Tina; Woodard, LeChauncy D; Winchester, David E; Ballantyne, Christie M; Petersen, Laura A; Virani, Salim S

    2016-04-01

    We sought to determine use of any and at least moderate-intensity statin therapy in a national sample of patients with diabetes mellitus (DM), with the hypothesis that nationwide frequency and facility-level variation in statin therapy are suboptimal. We sampled patients with DM age 40 to 75 years receiving primary care between October 1, 2012, and September 30, 2013, at 130 parent facilities and associated community-based outpatient clinics in the Veterans Affairs Health Care System. We examined frequency and facility-level variation in use of any or at least moderate-intensity statin therapy (mean daily dose associated with ≥30% low-density lipoprotein cholesterol lowering). In 911 444 patients with DM, 68.3% and 58.4% were receiving any and moderate- to high-intensity statin therapy, respectively. Patients receiving statin had higher burden of cardiovascular disease, were more likely to be on nonstatin lipid-lowering therapy and to receive care at a teaching facility, and had more frequent primary-care visits. Median facility-level uses of any and at least moderate-intensity statin therapy were 68.7% (interquartile range, 65.9%-70.8%) and 58.6% (interquartile range, 55.8%-61.4%), respectively. After adjusting for several patient-related and some facility-related characteristics, the median rate ratios for any and moderate- to high-intensity statin therapy were 1.20 (95% confidence interval: 1.18-1.22) and 1.29 (95% confidence interval: 1.24-1.33) respectively, indicating 20% to 29% variation in statin use between 2 identical patients receiving care at 2 random facilities. Statin use was suboptimal in a national sample of patients with DM with modest facility-level variation, likely indicating differences in statin-prescribing patterns. PMID:27059708

  15. Diabetes control with reciprocal peer support versus nurse care management: A randomized trial

    PubMed Central

    Heisler, Michele; Vijan, Sandeep; Makki, Fatima; Piette, John D.

    2014-01-01

    Background Many health care systems face barriers to implementing resource-intensive care management programs for patients with poorly controlled diabetes. Mobilizing patients to provide reciprocal peer support may enhance care management and improve clinical outcomes. Objective To compare the effectiveness of a reciprocal diabetes peer support program (RPS) with nurse care management (NCM) in improving glycemic control in real-world clinical settings. Design Six-month parallel randomized controlled effectiveness study from 2007–2010 (Trial Registration NCT00320112) Setting Two U.S. Veterans’Affairs (VA) health care facilities Participants 244 male diabetes patients with a hemoglobin A1c (HbA1c) in the prior 6 months of 7.5% or more. Primary Funding Source VA Health Services Research and Development (HSR&D) Measurements The primary outcome was change in HbA1c between baseline and six months. Secondary outcomes were new insulin starts and intensification, blood pressure, diabetes-specific social support, emotional distress, and medication adherence. Intervention Participants in both arms attended an initial session led by a nurse care manager to review and discuss their point-of-service HbA1c and blood pressure values, and most recent medical record cholesterol values. RPS patients then participated in a group session to set diabetes-related behavioral goals, receive brief training in peer communication skills, and be paired with another age-matched participant. Paired peer partners were encouraged to talk weekly using a telephone platform that recorded call frequency and duration and provided automated reminders promoting peer contact. Intervention participants were also offered three optional 1.5 hour patient-driven group sessions at months 1, 3, and 6 to share concerns, questions, strategies, and progress on goals. Patients in the NCM arm attended a 1.5 hour session to receive education on care manager services and diabetes educational materials and be

  16. An evaluation of recruitment methods utilized for a clinical trial with periodontal and diabetes enrollment criteria: the Diabetes and Periodontal Therapy Trial

    PubMed Central

    Schoenfeld, Elinor R; Hyman, Leslie; Simpson, Leslie Long; Michalowicz, Bryan; Reddy, Michael; Gelato, Marie; Hou, Wei; Engebretson, Steven P; Hytner, Catherine; Lenton, Pat

    2014-01-01

    Background Diabetes and its complications are a major United States public health concern. Methods The Diabetes and Periodontal Therapy Trial (DPTT) evaluated whether non-surgical treatment of periodontal disease influenced diabetes management among persons with Type 2 diabetes and periodontitis. The aim of this study was to evaluate DPTT’s many recruitment strategies in terms of enrollment success. Results/Conclusion Targeted recruitment strategies were more effective in identifying individuals who met periodontal and diabetes eligibility criteria. Individuals eligible for a baseline visit/enrollment were more often male, had a younger age at diabetes diagnosis, a longer diabetes duration, more often Hispanic and less often African–American. Tracking and evaluating recruitment sources during study enrollment optimized recruitment methods to enroll a diverse participant population based upon gender, race and ethnicity. PMID:25574373

  17. A Pilot Randomized Trial of Text-Messaging for Symptom Awareness and Diabetes Knowledge in Adolescents With Type 1 Diabetes

    PubMed Central

    Han, Yi; Faulkner, Melissa Spezia; Fritz, Heather; Fadoju, Doris; Muir, Andrew; Abowd, Gregory D.; Head, Lauren; Arriaga, Rosa I.

    2015-01-01

    Adolescents with type 1 diabetes typically receive clinical care every 3 months. Between visits, diabetes-related issues may not be frequently reflected, learned, and documented by the patients, limiting their self-awareness and knowledge about their condition. We designed a text-messaging system to help resolve this problem. In a pilot, randomized controlled trial with 30 adolescents, we examined the effect of text messages about symptom awareness and diabetes knowledge on glucose control and quality of life. The intervention group that received more text messages between visits had significant improvements in quality of life. PMID:25720675

  18. Glucometric assessment of gingival crevicular blood in diabetic and non-diabetic patients: A randomized clinical trial

    PubMed Central

    Debnath, Puja; Govila, Vivek; Sharma, Mona; Saini, Ashish; Pandey, Suraj

    2015-01-01

    Background Diabetes mellitus is one of the most incessant metabolic afflictions with high prevalence rate in Indians. Diagnosis of diabetics in the initial stage helps to prevent its long term complications that are responsible for high morbidity and mortality. The aim of the present study was to assess whether glucometric analysis using Gingival Crevicular Blood (GCB) can be used for screening of diabetic patients in dental chair. Materials and methods Present study was a double blinded randomized controlled trial. A total of 50 patients, 25 diabetic and 25 non-diabetic with chronic periodontitis were enrolled in the study. Blood oozing from the gingival crevices after periodontal pocket probing of anterior teeth and Finger Prick Blood (FPB) was taken and analysed by glucometer. Result Mean ± S.D was 195.84 ± 27.19 and 138.78 ± 29.95 for GCB and FPB respectively in diabetic group. For non-diabetic group Mean ± S.D was 103.84 ± 12.56 and 84.36 ± 10.36 respectively for GCB and FPB. A Karl Pearson correlation coefficient value of r = +0.735 for diabetic and r = +0.802 for non-diabetic group comparing GCB and FPB. Conclusion GCB cannot be used for screening blood glucose during periodontal examination. PMID:25853040

  19. Culturally adapting the prevention of diabetes and obesity in South Asians (PODOSA) trial.

    PubMed

    Wallia, S; Bhopal, R S; Douglas, A; Bhopal, R; Sharma, A; Hutchison, A; Murray, G; Gill, J; Sattar, N; Lawton, J; Tuomilehto, J; Mcknight, J; Forbes, J; Lean, M; Sheikh, A

    2014-12-01

    Type 2 diabetes is extremely common in South Asians, e.g. in men from Pakistani and Indian populations it is about three times as likely as in the general population in England, despite similarities in body mass index. Lifestyle interventions reduce the incidence of diabetes. Trials in Europe and North America have not, however, reported on the impact on South Asian populations separately or provided the details of their cross-cultural adaptation processes. Prevention of diabetes and obesity in South Asians (PODOSA) is a randomized, controlled trial in Scotland of an adapted, lifestyle intervention aimed at reducing weight and increasing physical activity to reduce type 2 diabetes in Indians and Pakistanis. The trial was adapted from the Finnish Diabetes Prevention Study. We describe, reflect on and discuss the following key issues: The core adaptations to the trial design, particularly the delivery of the intervention in homes by dietitians rather than in clinics. The use of both a multilingual panel and professional translators to help translate and/or develop materials. The processes and challenges of phonetic translation. How intervention resources were adapted, modified, newly developed and translated into Urdu and Gurmukhi (written Punjabi). The insights gained in PODOSA (including time pressures on investigators, imperfections in the adaptation process, the power of verbal rather than written information, the utilization of English and the mother-tongue languages simultaneously by participants and the costs) might help the research community, given the challenge of health promotion in multi-ethnic, urban societies. PMID:23574693

  20. High-density lipoprotein cholesterol as an independent risk factor in cardiovascular disease: assessing the data from Framingham to the Veterans Affairs High--Density Lipoprotein Intervention Trial.

    PubMed

    Boden, W E

    2000-12-21

    The Framingham Heart Study found that high-density lipoprotein cholesterol (HDL-C) was the most potent lipid predictor of coronary artery disease risk in men and women >49 years of age. The Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS), in which subjects were randomized to treatment with lovastatin or placebo, also reported a striking benefit of treatment, particularly in patients with HDL-C < or =35 mg/dL at baseline. Treatment with lovastatin was associated with a remarkable 45% reduction in events for this group. The Veterans Affairs HDL Intervention Trial (VA-HIT) randomized subjects to gemfibrozil or placebo. A high proportion of enrolled subjects with low HDL-C also had characteristics of the dysmetabolic syndrome. HDL-C likewise increased by 6% on treatment, total cholesterol was reduced by 4% and triglycerides by 31%. There was no change in low-density lipoprotein cholesterol (LDL-C) levels. These changes in lipid were associated with a cumulative 22% reduction in the trial primary endpoint of all-cause mortality and nonfatal myocardial infarction (MI). Additionally, significant reductions in secondary endpoints including death from coronary artery disease, nonfatal MI, stroke, transient ischemic attack, and carotid endarterectomy were associated with the increase in HDL-C. In VA-HIT, for every 1% increase in HDL-C, there was a 3% reduction in death or MI, a therapeutic benefit that eclipses the benefit associated with LDL-C reduction. PMID:11374850

  1. Predictors of cardiac morbidity in diabetic, new-onset diabetic and non-diabetic high-risk hypertensive patients: The Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial.

    PubMed

    Aksnes, Tonje A; Kjeldsen, Sverre E; Rostrup, Morten; Holzhauer, Björn; Hua, Tsushung A; Julius, Stevo

    2016-08-01

    Diabetic and new-onset diabetic patients with hypertension have higher cardiac morbidity than patients without diabetes. We aimed to investigate whether baseline predictors of cardiac morbidity, the major constituent of the primary endpoint in the Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial, were different in patients with diabetes and new-onset diabetes compared to patients without diabetes. In total, 15,245 high-risk hypertensive patients in the VALUE trial were followed for an average of 4.2 years. At baseline, 5250 patients were diabetic by the 1999 World Health Organization criteria, 1298 patients developed new-onset diabetes and 8697 patients stayed non-diabetic during follow-up. Cardiac morbidity was defined as a composite of myocardial infarction and heart failure requiring hospitalization, and baseline predictors were identified by univariate and multivariate stepwise Cox regression analyses. History of coronary heart disease (CHD) and age were the most important predictors of cardiac morbidity in both diabetic and non-diabetic patients. History of CHD, history of stroke and age were the only significant predictors of cardiac morbidity in patients with new-onset diabetes. Predictors of cardiac morbidity, in particular history of CHD and age, were essentially the same in high-risk hypertensive patients with diabetes, new-onset diabetes and without diabetes who participated in the VALUE trial. PMID:26808585

  2. Prevention of gestational diabetes in pregnant women with risk factors for gestational diabetes: a systematic review and meta-analysis of randomised trials

    PubMed Central

    Govinden, Gemma; Bustani, R; Song, S; Farrell, TA

    2015-01-01

    Background Gestational diabetes mellitus can be defined as ‘glucose intolerance or hyperglycaemia with onset or first recognition during pregnancy.’ Objective The objective of our systematic review was to see if there was any intervention that could be used for primary prevention of gestational diabetes mellitus in women with risk factors for gestational diabetes mellitus. Search strategy Major databases were searched from 1966 to Aug 2012 without language restriction. Selection criteria Randomised trials comparing intervention with standard care in women with risk factors for gestational diabetes were included. Meta-analysis was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement. The primary outcome assessed was the incidence of gestational diabetes. Data collection and analysis Data from included trials were extracted independently by two authors and analysed using Rev-Man 5. Main results A total of 2422 women from 14 randomised trials were included; which compared diet (four randomised trials), exercise (three randomised trials), lifestyle changes (five randomised trials) and metformin (two randomised trials) with standard care in women with risk factors for gestational diabetes mellitus. Dietary intervention was associated with a statistically significantly lower incidence of gestational diabetes (Odds ratio 0.33, 95% CI 0.14 to 0.76) and gestational hypertension (Odds ratio 0.28, 95% CI 0.09, 0.86) compared to standard care. There was no statistically significant difference in the incidence of gestational diabetes mellitus or in the secondary outcomes with exercise, lifestyle changes or metformin use compared to standard care. Conclusions The use of dietary intervention has shown a statistically significantly lower incidence of gestational diabetes mellitus and gestational hypertension compared to standard care in women with risk factors for gestational diabetes mellitus.

  3. Biomarkers in Type 1 diabetes: Application to the clinical trial setting

    PubMed Central

    Tooley, James E.; Herold, Kevan C.

    2014-01-01

    Purpose of Review Biomarkers of type 1 diabetes are important for assessing risk of developing disease, monitoring disease progression, and determining responses to clinical treatments. Here we review recent advances in the development of biomarkers of type 1 diabetes with a focus on their utility in clinical trials. Recent Findings Measurements of auto antibodies and metabolic outcomes have been the foundation of monitoring type 1 diabetes for the past 20 years. Recent advancements have lead to improvements in T cell specific assays that have been used in large-scale clinical trials to measure antigen specific T cell responses. Additionally, new tools are being developed for the measurement of β cell mass and death that will allow for more direct measurement of disease activity. Lastly, recent studies have used both immunologic and non-immunologic biomarkers to identify responders to treatments in clinical trials. Summary Use of biomarkers in the study of type 1 diabetes have largely not changed over the past 20 years, however recent advancements in the field are establishing new techniques that allow for more precise monitoring of disease progression. These new tools will ultimately lead to an improvement in understanding of disease and will be utilized in clinical trials. PMID:24937037

  4. Coronary revascularization in diabetic patients. A focus on the 3-year SYNTAX trial outcomes.

    PubMed

    Groot, M W; Head, S J; Bogers, Ad J J C; Kappetein, A P

    2012-05-01

    The prevalence of diabetes is growing worldwide. Diabetics are predisposed to coronary artery disease due to an increased rate of atherosclerosis. The optimal treatment for these patients remains uncertain. Randomized trials compared percutaneous coronary intervention (PCI) to coronary artery bypass surgery (CABG) to determine the most suitable revascularization strategy. Meta-analyses suggest a survival advantage in favor of surgery over angioplasty or stenting with bare-metal stents (BMS). New evidence was needed since advances in medical therapy, PCI technology, and surgical techniques have emerged. The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was the first to compare a drug-eluting stent to CABG and showed an increased rate of major adverse cardiac or cerebrovascular events after PCI. Results are mainly driven by the increased rates in patients with high lesion complexity; therefore, the current evidence suggests that diabetic patients with complex coronary disease have better outcomes with CABG. PMID:22430286

  5. Niacin therapy and the risk of new-onset diabetes: a meta-analysis of randomised controlled trials

    PubMed Central

    Goldie, Christina; Taylor, Allen J; Nguyen, Peter; McCoy, Cody; Zhao, Xue-Qiao; Preiss, David

    2016-01-01

    Objective Previous studies have suggested that niacin treatment raises glucose levels in patients with diabetes and may increase the risk of developing diabetes. We undertook a meta-analysis of published and unpublished data from randomised trials to confirm whether an association exists between niacin and new-onset diabetes. Methods We searched Medline, EMBASE and the Cochrane Central Register of Controlled Trials, from 1975 to 2014, for randomised controlled trials of niacin primarily designed to assess its effects on cardiovascular endpoints and cardiovascular surrogate markers. We included trials with ≥50 non-diabetic participants and average follow-up of ≥24 weeks. Published data were tabulated and unpublished data sought from investigators. We calculated risk ratios (RR) for new-onset diabetes with random-effects meta-analysis. Heterogeneity between trials was assessed using the I2 statistic. Results In 11 trials with 26 340 non-diabetic participants, 1371 (725/13 121 assigned niacin; 646/13 219 assigned control) were diagnosed with diabetes during a weighted mean follow-up of 3.6 years. Niacin therapy was associated with a RR of 1.34 (95% CIs 1.21 to 1.49) for new-onset diabetes, with limited heterogeneity between trials (I2=0.0%, p=0.87). This equates to one additional case of diabetes per 43 (95% CI 30 to 70) initially non-diabetic individuals who are treated with niacin for 5 years. Results were consistent regardless of whether participants received background statin therapy (p for interaction=0.88) or combined therapy with laropiprant (p for interaction=0.52). Conclusions Niacin therapy is associated with a moderately increased risk of developing diabetes regardless of background statin or combination laropiprant therapy. PMID:26370223

  6. [Cardiovascular trials in diabetes: past and present. Invited lecture of the XXXVth National Congress of the Spanish Society of Cardiology].

    PubMed

    Pyörälä, K

    2000-12-01

    The risk of coronary heart disease in subjects with Type2 diabetes is 2-4 times higher than in non-diabetic subjects of the same age. About 20% of patients with clinically established coronary heart disease have diabetes and the prognosis is much worse in diabetic than in non-diabetic patients. Trial evidence suggests that good blood glucose control reduces the risk of myocardial infarction in diabetic patients and improves prognosis after it. Trial evidence indicates that the benefit from antihypertensive treatment is at least as good in diabetic than in non-diabetic patients, and that diabetic patients with coronary heart disease or other form of atherosclerotic vascular disease should be treated with lipid-lowering drugs (usually with statins), if their LDL cholesterol levels on diet remain> 3.0 mmol/l (115 mg/dl). Trial evidence supports the use of aspirin in middle-aged or elderly diabetic patients. All diabetic patients should be advised to stop smoking. PMID:11171476

  7. Impact of Diabetes and Its Treatment on Cognitive Function Among Adolescents Who Participated in the Diabetes Control and Complications Trial

    PubMed Central

    Musen, Gail; Jacobson, Alan M.; Ryan, Christopher M.; Cleary, Patricia A.; Waberski, Barbara H.; Weinger, Katie; Dahms, William; Bayless, Meg; Silvers, Nancy; Harth, Judith; White, Neil

    2008-01-01

    OBJECTIVE—The purpose of this study was to evaluate whether severe hypoglycemia or intensive therapy affects cognitive performance over time in a subgroup of patients who were aged 13–19 years at entry in the Diabetes Control and Complications Trial (DCCT). RESEARCH DESIGN AND METHODS—This was a longitudinal study involving 249 patients with type 1 diabetes who were between 13 and 19 years old when they were randomly assigned in the DCCT. Scores on a comprehensive battery of cognitive tests obtained during the Epidemiology of Diabetes Interventions and Complications follow-up study, ∼18 years later, were compared with baseline performance. We assessed the effects of the original DCCT treatment group assignment, mean A1C values, and frequency of severe hypoglycemic events on eight domains of cognition. RESULTS—There were a total of 294 reported episodes of coma or seizure. Neither frequency of hypoglycemia nor previous treatment group was associated with decline on any cognitive domain. As in a previous analysis of the entire study cohort, higher A1C values were associated with declines in the psychomotor and mental efficiency domain (P < 0.01); however, the previous finding of improved motor speed with lower A1C values was not replicated in this subgroup analysis. CONCLUSIONS—Despite relatively high rates of severe hypoglycemia, cognitive function did not decline over an extended period of time in the youngest cohort of patients with type 1 diabetes. PMID:18606979

  8. An insight into the recent diabetes trials: what is the best approach to prevent macrovascular and microvascular complications?

    PubMed

    Konig, Manige; Lamos, Elizabeth Mary; Stein, Stephanie Aleskow; Davis, Stephen N

    2013-09-01

    Type 2 diabetes mellitus (T2DM) accounts for 90%-95% of all diabetes cases. The overarching goal in caring for patients with T2DM is to prevent microvascular and macrovascular complications with glycemic control. Several studies such as UKPDS, DCCT, and EDIC have been performed to evaluate the effects of glucose control on tissue complications in patients with diabetes. In recent diabetes trials including ACCORD, ADVANCE, VADT, BARI 2D, and ORIGIN, intensive glucose control did not prevent macrovascular complications in older patients with long-standing diabetes with either cardiovascular disease or risk factors for cardiovascular disease. In fact, intensive therapy was associated with increased mortality in the ACCORD trial. Although no clear macrovascular benefit was seen in these trials, analyses of earlier studies in younger patients with type 1 and type 2 diabetes have suggested a significant benefit of intensive glycemic control in patients with a shorter duration of diabetes and less vasculopathy. In the UKPDS, the incidence of microvascular disease, particularly retinopathy, was reduced significantly with intensive glucose control, but in the more recent trials (ACCORD, ADVANCE, VADT, ORIGIN) the benefit was relatively modest and limited to reduced proteinuria. Perhaps the most important message from the above trials is to optimize control of cardiovascular risk factors. Although the goal HbA1c to prevent microvascular and macrovascular complications, per the American Diabetes Association, is less than 7%, hypoglycemia should be avoided as it can increase the risk for severe cardiovascular events. PMID:23865412

  9. REDEEM: A Pragmatic Trial to Reduce Diabetes Distress

    PubMed Central

    Fisher, Lawrence; Hessler, Danielle; Glasgow, Russell E.; Arean, Patricia A.; Masharani, Umesh; Naranjo, Diana; Strycker, Lisa A.

    2013-01-01

    OBJECTIVE To compare three interventions to reduce diabetes distress (DD) and improve self-management among non–clinically depressed adults with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS In REDEEM, 392 adults with T2DM and DD were randomized to computer-assisted self-management (CASM), CASM plus DD-specific problem solving (CAPS), or a computer-administered minimal supportive intervention. Primary outcomes were Diabetes Distress Scale (DDS) total, the Emotional Burden (EB) and Regimen Distress (RD) DDS subscales, and diet, exercise, and medication adherence. RESULTS Significant and clinically meaningful reductions in DD (DDS, EB, and RD) and self-management behaviors occurred in all three conditions (P < 0.001), with no significant between-group differences. There was, however, a significant group × baseline distress interaction (P < 0.02), in which patients with high baseline RD in the CAPS condition displayed significantly larger RD reductions than those in the other two conditions. RD generated the most distress and displayed the greatest distress reduction as a result of intervention. The pace of DD reduction varied by patient age: older patients demonstrated significant reductions in DD early in the intervention, whereas younger adults displayed similar reductions later. Reductions in DD were accompanied by significant improvements in healthy eating, physical activity, and medication adherence, although not by change in HbA1c. CONCLUSIONS DD is malleable and highly responsive to intervention. Interventions that enhance self-management also reduce DD significantly, but DD-specific interventions may be necessary for patients with high initial levels of DD. Future research should identify the minimal, most cost-effective interventions to reduce DD and improve self-management. PMID:23735726

  10. Challenging Recruitment of Youth With Type 2 Diabetes Into Clinical Trials

    PubMed Central

    Nguyen, Tammy T.; Jayadeva, Vikas; Cizza, Giovanni; Brown, Rebecca J.; Nandagopal, Radha; Rodriguez, Luisa M.; Rother, Kristina I.

    2014-01-01

    Purpose To better understand and overcome difficulties with recruitment of adolescents with type 2 diabetes into clinical trials at three United States institutions, we reviewed recruitment and retention strategies in clinical trials of youth with various chronic conditions. We explored whether similar strategies might be applicable to pediatric patients with type 2 diabetes. Methods We compiled data on recruitment and retention of adolescents with type 2 diabetes at three centers (National Institutes of Health, Bethesda, Maryland; Baylor College of Medicine, Houston, Texas; and Children’s National Medical Center, Washington, DC) from January 2009 to December 2011. We also conducted a thorough literature review on recruitment and retention in adolescents with chronic health conditions. Results The number of recruited patients was inadequate for timely completion of ongoing trials. Our review of recruitment strategies in adolescents included monetary and material incentives, technology-based advertising, word-of-mouth referral, and continuous patient–research team contact. Cellular or Internet technology appeared promising in improving participation among youths in studies of various chronic conditions and social behaviors. Conclusions Adolescents with type 2 diabetes are particularly difficult to engage in clinical trials. Monetary incentives and use of technology do not represent “magic bullets,” but may presently be the most effective tools. Future studies should be conducted to explore motivation in this population. We speculate that (1) recruitment into interventional trials that address the main concerns of the affected youth (e.g., weight loss, body image, and stress management) combined with less tangible outcomes (e.g., blood glucose control) may be more successful; and (2) study participation and retention may be improved by accommodating patients’ and caregivers’ schedules, by scheduling study visits before and after working hours, and in more

  11. A Comprehensive Lifestyle Intervention to Prevent Type 2 Diabetes and Cardiovascular Diseases: the German CHIP Trial.

    PubMed

    Wennehorst, Katharina; Mildenstein, Klas; Saliger, Brunhild; Tigges, Corinna; Diehl, Hans; Keil, Thomas; Englert, Heike

    2016-04-01

    The prevalence of type 2 diabetes is continuously increasing. This chronic metabolic disorder is difficult to treat and imposes a considerable economic burden on the healthcare system. In view of the fact that type 2 diabetes is primarily caused by behavioral factors, effective preventive strategies are urgently needed. We examined the effects of a holistic lifestyle intervention on clinical and laboratory parameters as well as on the long-term diabetes risk in patients at risk to develop diabetes. We conducted a randomized controlled trial in a primary care setting in Hannover, Germany, with 83 patients diagnosed as (pre)diabetic or at risk for diabetes. CHIP Germany is a 40-hour coaching lifestyle intervention program for the primary and secondary prevention of type 2 diabetes and cardiovascular diseases. The intervention included a comprehensive nutrition and health educational program based on the American CHIP approach. The primary outcome parameter was the body mass index (BMI). Secondary outcome parameters included body weight, blood pressure, fasting glucose, HbA1c, blood lipids, and the FINDRISK score, which assesses long-term diabetes risk. At the final measurement after 12 months, in the intervention group the BMI was reduced by 1.4 versus 0.2 kg/m(2) in controls (p = .119). The mean sustained weight loss after 12 months was -4.1 kg in the intervention group versus -0.8 kg in controls. Furthermore, we found a trend toward a stronger reduction in blood pressure, fasting glucose, and HbA1c as well as an improved FINDRISK score in the intervention group, compared to controls. Although failing to reach statistical significance at the final assessment, this comprehensive lifestyle intervention showed a noticeable reduction in several cardiometabolic risk factors which may facilitate the prevention of diabetes. PMID:26739253

  12. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol

    PubMed Central

    Azar, Kristen MJ; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

    2015-01-01

    Background In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Objective Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Methods Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. Results A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. Conclusions The randomized trial will provide rigorous evidence regarding the efficacy of

  13. Evaluation of an online Diabetes Needs Assessment Tool (DNAT) for health professionals: a randomised controlled trial

    PubMed Central

    2009-01-01

    Background Continuous medical education is traditionally reliant to a large extent on self-directed learning based on individuals' perceived learning priorities. Evidence suggests that this ability to self-assess is limited, and more so in the least competent. Therefore, it may be of benefit to utilise some form of external assessment for this purpose. Many diabetes educational programmes have been introduced, but few have been assessed for their benefit in a systematic manner. As diabetes is an increasingly prevalent disease, methods for the dissemination and understanding of clinical guidelines need to be explored for their effectiveness. This paper describes the study design of a randomised controlled trial to evaluate the effectiveness of using an interactive online Diabetes Needs Assessment Tool (DNAT), that builds a learning curriculum based on identified knowledge gaps, compared with conventional self-directed learning. The study assesses the effect of these interventions on health professionals' knowledge of diabetes management, evaluates the acceptability of this process of learning and self-reported changes in clinical practice as a result of this novel educational process. Methods Following a baseline assessment, participants will be randomised to undergo a 4-month learning period where they will either be given access to the diabetes learning modules alone (control group) or a Diabetes Needs Assessment Tool (DNAT) plus the diabetes learning modules (intervention group). On completion of the DNAT, a personalised learning report will be created for each participant identifying needs alongside individualised recommendations of the most appropriate learning modules to meet those requirements. All participants will complete a Diabetes Knowledge Test before and immediately after the allocated learning and the primary outcome will be the state of knowledge at 4 months. Learners will also be surveyed immediately after the learning period to assess the

  14. Clinical trials on corticosteroids for diabetic macular edema

    PubMed Central

    Al Dhibi, Hassan A; Arevalo, J Fernando

    2013-01-01

    Diabetic macular edema (DME) is a common cause of visual impairment in diabetic patients. It is caused by an increase in the permeability of the perifoveal capillaries and a disruption of the blood retinal-barrier. The pathogenesis of DME is multifactorial. Several therapeutic modalities have been proposed for the treatment of DME. Corticosteroid treatments have emerged as an alternative therapy for persistent DME or refractory to conventional laser photocoagulation and other modalities, due to anti-inflammatory, anti-vascular endothelial growth factor and anti-proliferative effects. Many studies have demonstrated the beneficial therapeutic effect of corticosteroids with improvement to both retinal thickness and visual acuity in short-term on the treatment of DME. Peribulbar and intravitreal injections have been used to deliver steroids for DME with frequent injections due to the chronic and recurrent nature of the disease. Steroid-related side effects include elevated intraocular pressure, cataract, and injection related complications such as endophthalmitis, vitreous hemorrhage, and retinal detachment particularly with intravitreal steroid injections. In order to reduce the risks, complications and frequent dosing of intravitreal steroids, intravitreal implants have been developed recently to provide sustained release of corticosteroids and reduce repeated intravitreal injections for the management of DME. PMID:24379920

  15. Cluster Randomized Trial Assessing the Effect on Diabetes Control of Personalized Diabetes Complication Risk Assessment during Ophthalmology Exams

    PubMed Central

    2016-01-01

    Importance Optimization of glycemic control is critical to reduce diabetes related complications, but long-term success is challenging. Although vision loss is among the greatest fears of individuals with diabetes, comprehensive personalized diabetes education and risk assessments are not consistently employed in ophthalmology settings. Objective To determine whether point-of-care measurement of HbA1c and personalized diabetes complication risk assessments performed during retinal ophthalmology visits improve glycemic control as assessed by HA1c. Design/Setting Ophthalmologist office based clinical trial where investigators from 42 sites were randomly assigned to provide either study-prescribed augmented diabetes assessment and education, or usual care. Participants Adults with type 1 or 2 diabetes enrolled into two cohorts: “more frequent” than annual follow-up (502 control and 488 intervention participants) and “annual” follow-up (368 and 388 participants). Intervention(s) Point-of-care measurement of HbA1c, blood pressure, and retinopathy severity; individualized estimate of retinopathy progression risk derived from the visit findings; structured comparison and review of past and current clinical findings; and structured education with immediate assessment and feedback regarding participant understanding. Intervention was performed at enrollment and routine ophthalmic follow-up visits scheduled at least 12 weeks apart. Main Outcome Measure(s) Mean change in HbA1c from baseline to 1 year. Secondary outcomes included body mass index, blood pressure, and diabetes self-management practices and attitudes surveys. Results In the “more frequent” cohort, mean (SD) change in HbA1c at 1 year was −0.1% (1.5%) in the control group and −0.3% (1.4%) in the intervention group (adjusted mean difference −0.09%, 95% confidence interval −0.29% to +0.12%, P=0.35). In the “annual” cohort, mean (SD) change in HBA1c was 0.0% (1.1%) and −0.1% (1

  16. Cardiovascular outcome trials for anti-diabetes medication: A holy grail of drug development?

    PubMed

    John, Mathew; Gopalakrishnan Unnikrishnan, Ambika; Kalra, Sanjay; Nair, Tiny

    2016-01-01

    Since the time questions arose on cardiovascular safety of Rosiglitazone, FDA has suggested guidelines on conduct of studies on anti-diabetic drugs so as to prove that the cardiovascular risk is acceptable. Based on the cardiovascular risks of pre-approval clinical trials, guidelines have been made to conduct cardiovascular safety outcome trials (CVSOTs) prior to the drug approval or after the drug has been approved. Unlike the trials comparing the efficacy of antidiabetic agents, the CVSOTs examine the cardiovascular safety of a drug in comparison to standard of care. These trials are expensive aspects of drug development and are associated with various technical and operational challenges. More cost effective models of assessing cardiovascular safety like use of biomarkers, electronic medical records, pragmatic and factorial designs can be adopted. This article critically looks at the antidiabetic drug approval from a cardiovascular perspective by asking a few questions and arriving at answers. PMID:27543483

  17. The OnTrack Diabetes Web-Based Program for Type 2 Diabetes and Dysphoria Self-Management: A Randomized Controlled Trial Protocol

    PubMed Central

    Smith, Anthony Carl; Scuffham, Paul A; Parham, Sophie

    2015-01-01

    Background The prevalence of type 2 diabetes is rising with the majority of patients practicing inadequate disease self-management. Depression, anxiety, and diabetes-specific distress present motivational challenges to adequate self-care. Health systems globally struggle to deliver routine services that are accessible to the entire population, in particular in rural areas. Web-based diabetes self-management interventions can provide frequent, accessible support regardless of time and location Objective This paper describes the protocol of an Australian national randomized controlled trial (RCT) of the OnTrack Diabetes program, an automated, interactive, self-guided Web program aimed to improve glycemic control, diabetes self-care, and dysphoria symptoms in type 2 diabetes patients. Methods A small pilot trial is conducted that primarily tests program functionality, efficacy, and user acceptability and satisfaction. This is followed by the main RCT, which compares 3 treatments: (1) delayed program access: usual diabetes care for 3 months postbaseline followed by access to the full OnTrack Diabetes program; (2) immediate program: full access to the self-guided program from baseline onward; and (3) immediate program plus therapist support via Functional Imagery Training (FIT). Measures are administered at baseline and at 3, 6, and 12 months postbaseline. Primary outcomes are diabetes self-care behaviors (physical activity participation, diet, medication adherence, and blood glucose monitoring), glycated hemoglobin A1c (HbA1c) level, and diabetes-specific distress. Secondary outcomes are depression, anxiety, self-efficacy and adherence, and quality of life. Exposure data in terms of program uptake, use, time on each page, and program completion, as well as implementation feasibility will be conducted. Results This trial is currently underway with funding support from the Wesley Research Institute in Brisbane, Australia. Conclusions This is the first known trial of an

  18. Effect of Acupressure on Maternal Anxiety in Women With Gestational Diabetes Mellitus: A Randomized Clinical Trial.

    PubMed

    Bastani, Farideh

    2016-06-01

    Women with diabetes often experience a higher level of anxiety. The aim of the study was to evaluate the effect of acupressure on relieving anxiety of women with gestational diabetes mellitus (GDM). A randomized clinical trial was conducted on 60 women with GDM at a university hospital. The participants were allocated to an experimental and a placebo group (30 women per group). The experimental group received a nurse-provided acupressure at the true point, and the placebo group received pressure (touching) at a sham (false) point. Anxiety was measured immediately in the groups prior to and after a 2-day intervention by a questionnaire and the Visual Analogue Scale. The data were analyzed using descriptive and inferential statistics. Results indicated that the acupressure group had significantly lower anxiety than the placebo group (p ≤ .0001). In conclusion, the effects of acupressure appeared to be effective in reducing anxiety in diabetic pregnant women. PMID:25848127

  19. Diabetes

    MedlinePlus

    ... version of this page please turn Javascript on. Diabetes What is Diabetes? Too Much Glucose in the Blood Diabetes means ... high, causing pre-diabetes or diabetes. Types of Diabetes There are three main kinds of diabetes: type ...

  20. Randomized, Controlled Trial of Behavioral Family Systems Therapy for Diabetes: Maintenance and Generalization of Effects on Parent-Adolescent Communication

    ERIC Educational Resources Information Center

    Wysocki, Tim; Harris, Michael A.; Buckloh, Lisa M.; Mertlich, Deborah; Lochrie, Amanda Sobel; Taylor, Alexandra; Sadler, Michelle; White, Neil H.

    2008-01-01

    We report a randomized trial of a revised Behavioral Family Systems Therapy for Diabetes (BFST-D) intervention. Families of 104 adolescents with diabetes were randomized to standard care (SC) or to 6 months of an educational support group (ES) or BFST-D. Family communication and problem-solving skills were assessed at 0, 6, 12, and 18 months by…

  1. Partial meal replacement plan and quality of the diet at 1 year: Action for health in diabetes (Look AHEAD) trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Background Little is known about diet quality with a reduced-energy, low-fat, partial meal replacement plan, especially in individuals with type 2 diabetes. The Action for Health in Diabetes (Look AHEAD) trial implemented a partial meal replacement plan in the Intensive Lifestyle Intervention. Objec...

  2. Foot reflexology in feet impairment of people with type 2 diabetes mellitus: randomized trial 1

    PubMed Central

    da Silva, Natália Chantal Magalhães; Chaves, Érika de Cássia Lopes; de Carvalho, Emilia Campos; Carvalho, Leonardo César; Iunes, Denise Hollanda

    2015-01-01

    Abstract Objective: to evaluate the effect of foot reflexology on feet impairment of people with type 2 diabetes mellitus. Method: this is a randomized, controlled and blind clinical trial. The sample was comprised by people with type 2 diabetes mellitus who, after being randomized into Treated group (n = 21) and Control group (n = 24), received guidelines on foot self-care. To the Treated Group it was also provided 12 sessions of foot reflexology. The scores of impairment indicators related to skin and hair, blood circulation, tissue sensitivity and temperature were measured by means of the instrument for assessing tissue integrity of the feet of people with diabetes mellitus. Chi-square test, Fisher exact test, Mann-Whitney test and regression analyzes were applied to the data, considering a significance level of 5% (P value <0.05). Results: participants who received the therapy showed better scores in some impairment indicators related to skin and hair (hair growth, elasticity/turgor, hydration, perspiration, texture and integrity of the skin/ skin peeling). Conclusion: the foot reflexology had a beneficial effect on feet impairment of people with type 2 diabetes mellitus, which makes it a viable therapy, deserving investment. This study was registered in the Brazilian Registry of Clinical Trials - RBR-8zk8sz. PMID:26444161

  3. Yoga for Adults with Type 2 Diabetes: A Systematic Review of Controlled Trials.

    PubMed

    Innes, Kim E; Selfe, Terry Kit

    2016-01-01

    A growing body of evidence suggests yogic practices may benefit adults with type 2 diabetes (DM2). In this systematic review, we evaluate available evidence from prospective controlled trials regarding the effects of yoga-based programs on specific health outcomes pertinent to DM2 management. To identify qualifying studies, we searched nine databases and scanned bibliographies of relevant review papers and all identified articles. Controlled trials that did not target adults with diabetes, included only adults with type 1 diabetes, were under two-week duration, or did not include quantitative outcome data were excluded. Study quality was evaluated using the PEDro scale. Thirty-three papers reporting findings from 25 controlled trials (13 nonrandomized, 12 randomized) met our inclusion criteria (N = 2170 participants). Collectively, findings suggest that yogic practices may promote significant improvements in several indices of importance in DM2 management, including glycemic control, lipid levels, and body composition. More limited data suggest that yoga may also lower oxidative stress and blood pressure; enhance pulmonary and autonomic function, mood, sleep, and quality of life; and reduce medication use in adults with DM2. However, given the methodological limitations of existing studies, additional high-quality investigations are required to confirm and further elucidate the potential benefits of yoga programs in populations with DM2. PMID:26788520

  4. Yoga for Adults with Type 2 Diabetes: A Systematic Review of Controlled Trials

    PubMed Central

    Innes, Kim E.; Selfe, Terry Kit

    2016-01-01

    A growing body of evidence suggests yogic practices may benefit adults with type 2 diabetes (DM2). In this systematic review, we evaluate available evidence from prospective controlled trials regarding the effects of yoga-based programs on specific health outcomes pertinent to DM2 management. To identify qualifying studies, we searched nine databases and scanned bibliographies of relevant review papers and all identified articles. Controlled trials that did not target adults with diabetes, included only adults with type 1 diabetes, were under two-week duration, or did not include quantitative outcome data were excluded. Study quality was evaluated using the PEDro scale. Thirty-three papers reporting findings from 25 controlled trials (13 nonrandomized, 12 randomized) met our inclusion criteria (N = 2170 participants). Collectively, findings suggest that yogic practices may promote significant improvements in several indices of importance in DM2 management, including glycemic control, lipid levels, and body composition. More limited data suggest that yoga may also lower oxidative stress and blood pressure; enhance pulmonary and autonomic function, mood, sleep, and quality of life; and reduce medication use in adults with DM2. However, given the methodological limitations of existing studies, additional high-quality investigations are required to confirm and further elucidate the potential benefits of yoga programs in populations with DM2. PMID:26788520

  5. Engagement, Retention, and Progression to Type 2 Diabetes: A Retrospective Analysis of the Cluster-Randomised "Let's Prevent Diabetes" Trial

    PubMed Central

    Yates, Thomas; Troughton, Jacqui; Khunti, Kamlesh; Davies, Melanie J.

    2016-01-01

    Background Prevention of type 2 diabetes mellitus (T2DM) is a global priority. Let’s Prevent Diabetes is a group-based diabetes prevention programme; it was evaluated in a cluster-randomised trial, in which the primary analysis showed a reduction in T2DM (hazard ratio [HR] 0.74, 95% CI 0.48–1.14, p = 0.18). We examined the association of engagement and retention with the Let’s Prevent Diabetes prevention programme and T2DM incidence. Methods and Findings We used data from a completed cluster-randomised controlled trial including 43 general practices randomised to receive either standard care or a 6-h group structured education programme with an annual refresher course for 2 y. The primary outcome was progression to T2DM at 3 y. The characteristics of those who attended the initial education session (engagers) versus nonengagers and those who attended all sessions (retainers) versus nonretainers were compared. Risk reduction of progression to T2DM by level of attendance was compared to standard care. Eight hundred and eighty participants were recruited, with 447 to the intervention arm, of which 346 (77.4%) were engagers and 130 (29.1%) were retainers. Retainers and engagers were more likely to be older, leaner, and nonsmokers than nonretainers/nonengagers. Engagers were also more likely to be male and be from less socioeconomically deprived areas than nonengagers. Participants who attended the initial session and at least one refresher session were less likely to develop T2DM compared to those in the control arm (30 people of 248 versus 67 people of 433, HR 0.38 [95% CI 0.24–0.62]). Participants who were retained in the programme were also less likely to develop T2DM compared to those in the control arm (7 people of 130 versus 67 people of 433, HR 0.12 [95% CI 0.05–0.28]). Being retained in the programme was also associated with improvements in glucose, glycated haemoglobin (HbA1c), weight, waist circumference, anxiety, quality of life, and daily step

  6. Diabetes Insipidus

    MedlinePlus

    ... Nephrogenic Diabetes Insipidus Foundation MedlinePlus Alternate Language URL Diabetes Insipidus Page Content On this page: What is ... Nutrition Points to Remember Clinical Trials What is diabetes insipidus? Diabetes insipidus is a rare disorder that ...

  7. The Melbourne Diabetes Prevention Study (MDPS): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Worldwide, type 2 diabetes (T2DM) prevalence has more than doubled over two decades. In Australia, diabetes is the second highest contributor to the burden of disease. Lifestyle modification programs comprising diet changes, weight loss and moderate physical activity, have been proven to reduce the incidence of T2DM in high risk individuals. As part of the Council of Australia Governments, the State of Victoria committed to develop and support the diabetes prevention program ‘Life! Taking action on diabetes’ (Life!) which has direct lineage from effective clinical and implementation trials from Finland and Australia. The Melbourne Diabetes Prevention Study (MDPS) has been set up to evaluate the effectiveness and cost-effectiveness of a specific version of the Life! program. Methods/design We intend to recruit 796 participants for this open randomized clinical trial; 398 will be allocated to the intervention arm and 398 to the usual care arm. Several methods of recruitment will be used in order to maximize the number of participants. Individuals aged 50 to 75 years will be screened with a risk tool (AUSDRISK) to detect those at high risk of developing T2DM. Those with existing diabetes will be excluded. Intervention participants will undergo anthropometric and laboratory tests, and comprehensive surveys at baseline, following the fourth group session (approximately three months after the commencement of the intervention) and 12 months after commencement of the intervention, while control participants will undergo testing at baseline and 12 months only. The intervention consists of an initial individual session followed by a series of five structured-group sessions. The first four group sessions will be carried out at two week intervals and the fifth session will occur eight months after the first group session. The intervention is based on the Health Action Process Approach (HAPA) model and sessions will empower and enable the participants to follow

  8. Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial

    PubMed Central

    Wild, Sarah H.; Hanley, Janet; Lewis, Stephanie C.; McKnight, John A.; Padfield, Paul L.; Parker, Richard A.; Pinnock, Hilary; Sheikh, Aziz; McKinstry, Brian

    2016-01-01

    Background Self-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes. Methods and Findings We performed a randomized, parallel, investigator-blind controlled trial with centralized randomization in family practices in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin (HbA1c) >58 mmol/mol. The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group. The control group received usual care, with at least annual review and more frequent reviews for people with poor glycemic or blood pressure control. HbA1c assessed at 9 mo was the primary outcome. Intention-to-treat analyses were performed. 160 people were randomized to the intervention group and 161 to the usual care group between June 6, 2011, and July 19, 2013. HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group. The mean (SD) HbA1c at follow-up was 63.0 (15.5) mmol/mol in the intervention group and 67.8 (14.7) mmol/mol in the usual care group. For primary analysis, adjusted mean HbA1c was 5.60 mmol/mol / 0.51% lower (95% CI 2.38 to 8.81 mmol/mol/ 95% CI 0.22% to 0.81%, p = 0·0007). For secondary analyses, adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower (95% CI 0.56–5.56 mmHg, p = 0.017) and mean ambulatory diastolic blood pressure was 2.17 mmHg lower (95% CI 0.62–3.72, p = 0.006) among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata. No significant

  9. [Treatment of patients with type 2 diabetes mellitus: cardiovascular safety of incretin-based therapy supported by the ELIXA and TECOS trials].

    PubMed

    Avogaro, Angelo

    2016-04-01

    The risk of morbidity and mortality from cardiovascular disease in patients with type 2 diabetes is about 2-fold higher compared to their non-diabetic counterparts. In December 2008, the Food and Drug Administration published guidelines for the evaluation of cardiovascular risk in new antidiabetic therapies. A shift of emphasis occurred from short-term glycated hemoglobin-centered trials to trials testing cardiovascular safety. The SAVOR-TIMI 53 and the EXAMINE trials with the dipeptidyl peptidase 4 (DPP-4) inhibitors saxagliptin and alogliptin were cardiovascular neutral. The publication of the results of the TECOS trial with sitagliptin, another DPP-4 inhibitor, the American Diabetes Association 2015 presentation of the ELIXA trial with lixisenatide, the first cardiovascular safety trial with glucagon-like peptide 1 receptor agonists, have also been completed. They both show cardiovascular neutrality in very high-risk diabetic patients. The results of these trials are interpreted in the context of diabetic treatment. PMID:27093207

  10. Intervention trials for prevention of metabolic syndrome and type 2 diabetes: focus on Asian Indians.

    PubMed

    Shrivastava, Usha; Misra, Anoop

    2014-08-01

    Prevalence of diabetes continues to increase in urban areas, and escalation is discernible in semi-urban and rural areas. It is reported to affect Asian Indians a decade earlier compared with other populations, and complications (e.g., nephropathy) occur earlier and are severe and more prevalent than in other races. Because of these adverse features and suboptimal management practices, type 2 diabetes mellitus (T2DM) poses a huge health and economic burden to the country. Simple and culturally sensitive interventions for Asian Indians have been shown to be effective in prevention/amelioration of diabetes and other cardiovascular risk factors in multiple settings, among urban and rural residents, in migrants, and in those who are healthy or obese or have metabolic syndrome or T2DM. Furthermore, short-term intensive lifestyle intervention in children improves anthropometric and metabolic parameters. Finally, intervention with specific nutrient or oil substitution in Indian diets has been reported to produce benefit in multiple metabolic cardiovascular risk factors. There is, however, further need for conducting well-designed and planned intervention trials with robust outcome data at the primary and secondary levels. These trials must be culturally sensitive and should investigate cost-effective strategies. PMID:24750100

  11. Alberta Diabetes and Physical Activity Trial (ADAPT): A randomized theory-based efficacy trial for adults with type 2 diabetes - rationale, design, recruitment, evaluation, and dissemination

    PubMed Central

    2010-01-01

    Background The primary aim of this study was to compare the efficacy of three physical activity (PA) behavioural intervention strategies in a sample of adults with type 2 diabetes. Method/Design Participants (N = 287) were randomly assigned to one of three groups consisting of the following intervention strategies: (1) standard printed PA educational materials provided by the Canadian Diabetes Association [i.e., Group 1/control group)]; (2) standard printed PA educational materials as in Group 1, pedometers, a log book and printed PA information matched to individuals' PA stage of readiness provided every 3 months (i.e., Group 2); and (3) PA telephone counseling protocol matched to PA stage of readiness and tailored to personal characteristics, in addition to the materials provided in Groups 1 and 2 (i.e., Group 3). PA behaviour measured by the Godin Leisure Time Exercise Questionnaire and related social-cognitive measures were assessed at baseline, 3, 6, 9, 12 and 18-months (i.e., 6-month follow-up). Clinical (biomarkers) and health-related quality of life assessments were conducted at baseline, 12-months, and 18-months. Linear Mixed Model (LMM) analyses will be used to examine time-dependent changes from baseline across study time points for Groups 2 and 3 relative to Group 1. Discussion ADAPT will determine whether tailored but low-cost interventions can lead to sustainable increases in PA behaviours. The results may have implications for practitioners in designing and implementing theory-based physical activity promotion programs for this population. Clinical Trials Registration ClinicalTrials.gov identifier: NCT00221234 PMID:20067626

  12. Insulin use early in the course of type 2 diabetes mellitus: the ORIGIN trial.

    PubMed

    Hanefeld, Markolf; Bramlage, Peter

    2013-06-01

    There has been a recent shift from a uniform treatment targeting HbA1c to a patient centered approach due to disappointing results of intensified glucose control in mega-trials such as VADT, ADVANCE, and ACCORD. In addition, morbidity and mortality has been substantially reduced since the UKPDS leading to an overestimation of the absolute risk for cardiovascular complications in randomized controlled trials. With substantial progress in prevention of cardiovascular complications, patients with type 2 diabetes now survive long enough to face diabetes-related complications and cancer risk. This requires rethinking of antidiabetic treatment strategies as exemplified by a recent consensus statement of the EASD and ADA, calling for a more patient centered treatment. Within this context the value of early insulin initiation was reinforced, the clinical utility of which has been demonstrated in the recent ORIGIN trial. ORIGIN demonstrated neutral results for the primary endpoint, but reduced microangiopathy in patients with an HbA1c value of ≥6.4 % with basal insulin glargine. After 5 years of follow-up 77 % of the patients in the glargine arm and 66 % with standard care remained at an HbA1c <7 %. An ongoing long-term follow-up (ORIGINALE) will clarify whether this also translates into a reduction of macrovascular events and mortality. PMID:23397557

  13. Continued efforts to translate diabetes cardiovascular outcome trials into clinical practice.

    PubMed

    Avogaro, Angelo; Fadini, Gian Paolo; Sesti, Giorgio; Bonora, Enzo; Del Prato, Stefano

    2016-01-01

    Diabetic patients suffer from a high rate of cardiovascular events and such risk increases with HbA1c. However, lowering HbA1c does not appear to yield the same benefit on macrovascular endpoints, as observed for microvascular endpoints. As the number of glucose-lowering medications increases, clinicians have to consider several open questions in the management of type 2 diabetes, one of which is the cardiovascular risk profile of each regimen. Recent placebo-controlled cardiovascular outcome trials (CVOTs) have responded to some of these questions, but careful interpretation is needed. After general disappointment around CVOTs assessing safety of DPP-4 inhibitors (SAVOR, TECOS, EXAMINE) and the GLP-1 receptor agonist lixisenatide (ELIXA), the EMPA-REG Outcome trial and the LEADER trial have shown superiority of the SGLT2-I empagliflozin and the GLP-1RA liraglutide, respectively, on the 3-point MACE outcome (cardiovascular death, non-fatal myocardial infarction or stroke) and cardiovascular, as well as all-cause mortality. While available mechanistic studies largely support a cardioprotective effect of GLP-1, the ability of SGLT2 inhibitor(s) to prevent cardiovascular death was unexpected and deserves future investigation. We herein review the results of completed CVOTs of glucose-lowering medications and suggest a possible treatment algorithm based on cardiac and renal co-morbidities to translate CVOT findings into clinical practice. PMID:27514514

  14. Mothers after Gestational Diabetes in Australia (MAGDA): A Randomised Controlled Trial of a Postnatal Diabetes Prevention Program

    PubMed Central

    O’Reilly, Sharleen L.; Versace, Vincent; Best, James D.; Carter, Rob; Oats, Jeremy J. N.; Ackland, Michael; Ebeling, Peter R.; Shih, Sophy T. F.; Hagger, Virginia; Coates, Michael; Wildey, Carol

    2016-01-01

    being near normal at baseline. Conclusions Although a 1-kg weight difference has the potential to be significant for reducing diabetes risk, the level of engagement during the first postnatal year was low. Further research is needed to improve engagement, including participant involvement in study design; it is potentially more effective to implement annual diabetes screening until women develop prediabetes before offering an intervention. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12610000338066 PMID:27459502

  15. BMI and Health Status in the Bypass Angioplasty Revascularization Investigation 2 Diabetes Trial (BARI 2D)

    PubMed Central

    Chung, Sheng-Chia; Hlatky, Mark A.; Stone, Roslyn A.; Rana, Jamal S.; Escobedo, Jorge; Rogers, William J.; Bromberger, Joyce T.; Kelsey, Sheryl F.; Brooks, Maria Mori

    2011-01-01

    BACKGROUND The longitudinal association between obesity, weight variability and health status outcomes is important for patients with coronary disease and diabetes. METHODS The Bypass Angioplasty Revascularization Investigation 2 Diabetes trial (BARI 2D) was a multi-center randomized clinical trial to evaluate the best treatment strategy for patients with both documented stable ischemic heart disease and type 2 diabetes. We examined BARI 2D participants for four years to study how BMI was associated with health status outcomes. Health status was evaluated by the Duke Activity Status Index (DASI), RAND Energy/fatigue, Health Distress, and Self-rated health. BMI was measured quarterly throughout follow-up years, and health status was assessed at each annual follow-up visit. Variation in BMI measures was separated into between-person and within-person change in longitudinal analysis. RESULTS Higher mean BMI over follow-up years (the between-person BMI) was associated with poorer health status outcomes. Decreasing BMI (the within-person BMI change) was associated with better Self-rated health. The relationships between BMI variability and DASI or Energy appeared to be curvilinear, and differed by baseline obesity status. Decreasing BMI was associated with better outcomes if patients were obese at baseline, but was associated with poorer DASI and Energy outcomes if patients were non-obese at baseline. CONCLUSIONS For patients with stable ischemic heart disease and diabetes, weight gain was associated with poorer health status outcomes, independent of obesity-related comobidities. Weight reduction is associated with better functional capacity and perceived energy for obese patients but not for non-obese patients at baseline. PMID:21742107

  16. A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial

    PubMed Central

    2014-01-01

    control over the course of the study. Conclusion Among Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing psychological well-being. Trial registration ClinicalTrials.gov Identified NCT00090506. PMID:24980650

  17. Clinical Implications of Cardiovascular Outcome Trials in Type 2 Diabetes: From DCCT to EMPA-REG.

    PubMed

    Rydén, Lars; Shahim, Bahira; Mellbin, Linda

    2016-06-01

    Cardiovascular disease is a major threat to people with diabetes. Attempts have long been made to lower cardiovascular risk by means of glucose-lowering treatment. Initially, it seemed that was an option, but subsequent trials could not verify the original observations and there was concern that some glucose-lowering drugs can actually cause cardiovascular harm. This led medical product agencies in the United States and Europe to require major outcomes trials before accepting new glucose-lowering drugs. The least requirement was noninferiority compared with existing treatment modalities. A large number of such trials have been performed or are ongoing, including >100,000 patients. The drug classes investigated are basal insulin, glucagon-like peptide-1 agonists, dipeptidyl peptidase 4 inhibitors, and sodium-glucose cotransporter-2 (SGLT2) inhibitors. This commentary discusses these trials and their outcomes, the reasons why several of them ended with neutral results (noninferiority), and that the likelihood for showing cardiovascular benefit was minor or even nonexistent. The surprising and highly rewarding impact of the SGLT2 inhibitor empagliflozin is described and potential mechanisms for cardiovascular benefits are discussed. PMID:27107734

  18. HbA1c as a Predictor of Diabetes and as an Outcome in the Diabetes Prevention Program: A Randomized Clinical Trial

    PubMed Central

    2015-01-01

    OBJECTIVE Glycated hemoglobin (HbA1c), a standard measure of chronic glycemia for managing diabetes, has been proposed to diagnose diabetes and identify people at risk. The Diabetes Prevention Program (DPP) was a 3.2-year randomized clinical trial of preventing type 2 diabetes with a 10-year follow-up study, the DPP Outcomes Study (DPPOS). We evaluated baseline HbA1c as a predictor of diabetes and determined the effects of treatments on diabetes defined by an HbA1c ≥6.5% (48 mmol/mol). RESEARCH DESIGN AND METHODS We randomized 3,234 nondiabetic adults at high risk of diabetes to placebo, metformin, or intensive lifestyle intervention and followed them for the development of diabetes as diagnosed by fasting plasma glucose (FPG) and 2-h postload glucose (2hPG) concentrations (1997 American Diabetes Association [ADA] criteria). HbA1c was measured but not used for study eligibility or outcomes. We now evaluate treatment effects in the 2,765 participants who did not have diabetes at baseline according to FPG, 2hPG, or HbA1c (2010 ADA criteria). RESULTS Baseline HbA1c predicted incident diabetes in all treatment groups. Diabetes incidence defined by HbA1c ≥6.5% was reduced by 44% by metformin and 49% by lifestyle during the DPP and by 38% by metformin and 29% by lifestyle throughout follow-up. Unlike the primary DPP and DPPOS findings based on glucose criteria, metformin and lifestyle were similarly effective in preventing diabetes defined by HbA1c. CONCLUSIONS HbA1c predicted incident diabetes. In contrast to the superiority of the lifestyle intervention on glucose-defined diabetes, metformin and lifestyle interventions had similar effects in preventing HbA1c-defined diabetes. The long-term implications for other health outcomes remain to be determined. PMID:25336746

  19. A randomized comparative effectiveness trial of using cable television to deliver diabetes prevention programming

    PubMed Central

    Ackermann, Ronald T; Sandy, Lewis G; Beauregard, Tom; Coblitz, Mark; Norton, Kristi L; Vojta, Deneen

    2014-01-01

    Objective To evaluate the use and effectiveness of two “in-home” strategies for delivering diabetes prevention programming using cable television. Methods An individually randomized, two-arm intervention trial including adults with diabetes risk factors living in two US cities. Interventions involved a 16-session lifestyle intervention delivered via “video-on-demand” cable television, offered alone versus in combination with web-based lifestyle support tools. Repeated measures longitudinal linear regression with imputation of missing observations was used to compare changes in body weight. Results A total of 306 individuals were randomized and offered the interventions. After 5 months, 265 (87%) participants viewed at least 1, and 110 (36%) viewed ≥9 of the video episodes. A total of 262 (86%) participants completed a 5-month weight measurement. In intention-to-treat analysis with imputation of missing observations, mean weight loss at 5 months for both treatment groups combined was 3.3% (95% CI 0.7-5.0%), regardless of intervention participation (with no differences between randomized groups (P = 0.19)), and was 4.9% (95% CI 2.1-6.5%) for participants who viewed ≥9 episodes. Conclusions In-home delivery of evidence-based diabetes prevention programming in a reality television format, offered with or without online behavioral support tools, can achieve modest weight losses consistent with past implementation studies of face-to-face programs using similar content. PMID:24740868

  20. Treatment of mild and moderate type-2 diabetes: open prospective trial with Hintonia latiflora extract

    PubMed Central

    2014-01-01

    Background Extracts from the bark of Hintonia latiflora are used as dietetic measures to support the regulation of glucose metabolism and the stabilization of blood glucose values. Methods A dry concentrated extract from the bark of Hintonia latiflora in capsule form was tested in an open, prospective clinical study in 41 dietetically stabilized subjects with type 2 diabetes. The effects on parameters of blood glucose control were documented over a period of six months. Results Fasting and postprandial glucose and the HbA1c value declined significantly. In the case of HbA1c, this meant a reduction of the absolute value from 7.49 ± 0.72% to 6.82 ± 0.67% (from 58.4 to 51.0 mmol/mol Hb; intention to treat (ITT) population). Furthermore, cholesterol and triglycerides were slightly reduced and no negative effect on other laboratory parameters and no change of the liver values were observed. Tolerance was very good. In particular, no side effects and no hypoglycemic episodes or worsening of diabetic symptoms occurred. Conclusions The study confirms the positive effect of extracts from the bark of Hintonia latiflora on blood glucose values suggesting a potential benefit in the management of glucose metabolism in cases of type 2 diabetes. Trial registration Reg.-No. ISRCTN83308122 PMID:24678614

  1. Resistance Exercise in Already-Active Diabetic Individuals (READI): study rationale, design and methods for a randomized controlled trial of resistance and aerobic exercise in type 1 diabetes.

    PubMed

    Yardley, Jane E; Kenny, Glen P; Perkins, Bruce A; Riddell, Michael C; Goldfield, Gary S; Donovan, Lois; Hadjiyannakis, Stasia; Wells, George A; Phillips, Penny; Sigal, Ronald J

    2015-03-01

    The Resistance Exercise in Already Active Diabetic Individuals (READI) trial aimed to examine whether adding a 6-month resistance training program would improve glycemic control (as reflected in reduced HbA₁c) in individuals with type 1 diabetes who were already engaged in aerobic exercise compared to aerobic training alone. After a 5-week run-in period including optimization of diabetes care and low-intensity exercise, 131 physically active adults with type 1 diabetes were randomized to two groups for 22weeks: resistance training three times weekly, or waiting-list control. Both groups maintained the same volume, duration and intensity of aerobic exercise throughout the study as they did at baseline. HbA₁c, body composition, frequency of hypoglycemia, lipids, blood pressure, apolipoproteins B and A-1 (ApoB and ApoA1), the ApoB-ApoA1 ratio, urinary albumin excretion, serum C-reactive protein, free fatty acids, total daily insulin dose, health-related quality of life, cardiorespiratory fitness and musculoskeletal fitness were recorded at baseline, 3 (for some variables), and 6 months. To our knowledge, READI is the only trial to date assessing the incremental health-related impact of adding resistance training for individuals with type 1 diabetes who are already aerobically active. Few exercise trials have been completed in this population, and even fewer have assessed resistance exercise. With recent improvements in the quality of diabetes care, the READI study will provide conclusive evidence to support or refute a major clinically relevant effect of exercise type in the recommendations for physical activity in patients with type 1 diabetes. PMID:25559915

  2. Aerobic and Combined Exercise Sessions Reduce Glucose Variability in Type 2 Diabetes: Crossover Randomized Trial

    PubMed Central

    Figueira, Franciele R.; Umpierre, Daniel; Casali, Karina R.; Tetelbom, Pedro S.; Henn, Nicoli T.; Schaan, Beatriz D.

    2013-01-01

    Purpose To evaluate the effects of aerobic (AER) or aerobic plus resistance exercise (COMB) sessions on glucose levels and glucose variability in patients with type 2 diabetes. Additionally, we assessed conventional and non-conventional methods to analyze glucose variability derived from multiple measurements performed with continuous glucose monitoring system (CGMS). Methods Fourteen patients with type 2 diabetes (56±2 years) wore a CGMS during 3 days. Participants randomly performed AER and COMB sessions, both in the morning (24 h after CGMS placement), and at least 7 days apart. Glucose variability was evaluated by glucose standard deviation, glucose variance, mean amplitude of glycemic excursions (MAGE), and glucose coefficient of variation (conventional methods) as well as by spectral and symbolic analysis (non-conventional methods). Results Baseline fasting glycemia was 139±05 mg/dL and HbA1c 7.9±0.7%. Glucose levels decreased immediately after AER and COMB protocols by ∼16%, which was sustained for approximately 3 hours. Comparing the two exercise modalities, responses over a 24-h period after the sessions were similar for glucose levels, glucose variance and glucose coefficient of variation. In the symbolic analysis, increases in 0 V pattern (COMB, 67.0±7.1 vs. 76.0±6.3, P = 0.003) and decreases in 1 V pattern (COMB, 29.1±5.3 vs. 21.5±5.1, P = 0.004) were observed only after the COMB session. Conclusions Both AER and COMB exercise modalities reduce glucose levels similarly for a short period of time. The use of non-conventional analysis indicates reduction of glucose variability after a single session of combined exercises. Trial Registration Aerobic training, aerobic-resistance training and glucose profile (CGMS) in type 2 diabetes (CGMS exercise). ClinicalTrials.gov ID: NCT00887094. PMID:23536769

  3. 2012 update on diabetic kidney disease: the expanding spectrum, novel pathogenic insights and recent clinical trials.

    PubMed

    Fernández Fernández, B; Elewa, U; Sánchez-Niño, M D; Rojas-Rivera, J E; Martin-Cleary, C; Egido, J; Ortiz, A

    2012-08-01

    Diabetic kidney disease (DKD) is the most frequent cause of end-stage renal disease in western countries. This implies that current methods based of renin angiotensin aldosterone system (RAAS) targeting for preventing, slowing or promoting regression of DKD are insufficient. Podocyte injury and albuminuria are thought to be key events in DKD. Indeed several DKD stages are recognized based on the magnitude of albuminuria. However, the spectrum of DKD has recently expanded, as lack of significant albuminuria is present in 30% of diabetics with kidney function impairment. This may result from the widespread use of drugs targeting the RAAS. However, it may also indicate that additional pathogenic factors contribute to renal function deterioration despite control of albuminuria. In this regard, double blockade of the RAAS is more effective in reducing albuminuria that blockade of a single component. However, clinical trials assessing double blockade for renal function preservation have been disappointing and raised safety issues. Non-biased -omics approaches have uncovered alternative therapeutic targets, including the cytokine TRAIL, the MIF receptor CD74 and the proapoptotic intracellular protein BASP1. In addition, urinary proteomics has uncovered a peptidomic fingerprint for DKD progression that precedes the onset of microalbuminuria. Studies are underway to validate this fingerprint for early treatment of high risk patients. Recent clinical trials suggest a potential role of bardoxolone methyl to improve renal function in advanced DKD, while trials of avosentan, pirfenidone, sulodexide and pyridoxamine have been disappointing and further data are needed for paricalcitol and vitamin D, newer generation endothelin receptor antagonists and pentoxifylline. PMID:22805616

  4. Performance of an Electronic Diary System for Intensive Insulin Management in Global Diabetes Clinical Trials

    PubMed Central

    Zhang, Shuyu; Mou, Jiani; Hackett, Andy P.; Raymond, Stephen A.; Chang, Annette M.

    2015-01-01

    Abstract Background: This report describes the performance of a wireless electronic diary (e-diary) system for data collection and enhanced patient–investigator interactions during intensive insulin management in diabetes clinical trials. Materials and Methods: We implemented a customized electronic communication system featuring an e-diary and a Web portal in three global, randomized, controlled Phase 3 clinical trials testing basal insulin peglispro compared with insulin glargine, both combined with prandial insulin lispro, in patients with type 1 or type 2 diabetes mellitus (T1DM and T2DM, respectively). We collected data during 28 weeks of study e-diary use for the report. Results: Patients (n=2,938) in 31 countries used e-diaries to transmit 2,439,087 blood glucose (BG) values, 96% of which were associated by the patient with a protocol time point during the 72-h response window. Of 208,192 hypoglycemia events captured, 96% had a BG value, and 95% had treatments and outcomes entered by patients within the 72-h window. Patients recorded administration of 1,964,477 insulin doses; 93% of basal insulin doses were adherent with the investigator prescription. Investigators adjusted 13 basal and 92 bolus insulin prescriptions per patient-year using the e-diary system. After 26 weeks of treatment and e-diary use in the combined study arms, hemoglobin A1c values decreased by 0.6% or 1.6% and fasting BG decreased by 7.8 or 28 mg/dL in patients with T1DM or T2DM, respectively. Conclusions: The e-diary system enabled comprehensive data collection and facilitated communication between investigators and patients for intensive insulin management in three global clinical trials testing basal insulins. PMID:25826466

  5. Periodontal treatment to improve glycaemic control in diabetic patients: study protocol of the randomized, controlled DIAPERIO trial

    PubMed Central

    Vergnes, Jean-Noel; Arrivé, Elise; Gourdy, Pierre; Hanaire, Hélène; Rigalleau, Vincent; Gin, Henri; Sédarat, Cyril; Dorignac, Georges; Bou, Christophe; Sixou, Michel; Nabet, Cathy

    2009-01-01

    Background Periodontitis is a common, chronic inflammatory disease caused by gram-negative bacteria leading to destruction of tissues supporting the teeth. Epidemiological studies have consistently shown increased frequency, extent and severity of periodontitis among diabetic adults. More recently, some controlled clinical trials have also suggested that periodontal treatment could improve glycaemic control in diabetic patients. However current evidence does not provide sufficient information on which to confidently base any clinical recommendations. The main objective of this clinical trial is to assess whether periodontal treatment could lead to a decrease in glycated haemoglobin levels in metabolically unbalanced diabetic patients suffering from chronic periodontitis. Methods The DIAPERIO trial is an open-label, 13-week follow-up, randomized, controlled trial. The total target sample size is planned at 150 participants, with a balanced (1:1) treatment allocation (immediate treatment vs delayed treatment). Periodontal treatment will include full mouth non-surgical scaling and root planing, systemic antibiotherapy, local antiseptics (chlorhexidine 0.12%) and oral health instructions. The primary outcome will be the difference in change of HbA1c between the two groups after the 13-weeks' follow-up. Secondary outcomes will be the difference in change of fructosamine levels and quality of life between the two groups. Discussion The DIAPERIO trial will provide insight into the question of whether periodontal treatment could lead to an improvement in glycaemic control in metabolically unbalanced diabetic patients suffering from periodontitis. The results of this trial will help to provide evidence-based recommendations for clinicians and a draft framework for designing national health policies. Trial registration Current Controlled Trials ISRCTN15334496 PMID:19646281

  6. A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes: The Triabetes Study

    PubMed Central

    Courcoulas, Anita P.; Goodpaster, Bret H.; Eagleton, Jessie K; Belle, Steven H.; Kalarchian, Melissa A.; Lang, Wei; Toledo, Frederico G. S.; Jakicic, John M.

    2014-01-01

    IMPORTANCE Address unanswered questions about the role of bariatric surgery for people with diabetes. OBJECTIVE Determine feasibility of a randomized controlled trial (RCT) and compare initial outcomes of bariatric surgery and a structured weight loss program for treating type 2 diabetes mellitus in grade 1 and 2 obese participants. DESIGN, SETTING, PARTICIPANTS A 12-month, 3-arm RCT at a single center including 69 participants age 25–55 years, BMI 30–40 with type 2 diabetes. INTERVENTIONS Two surgical procedures; Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric band (LAGB) and an intensive lifestyle weight loss intervention (LWLI). MAIN OUTCOMES AND MEASURES Primary outcomes in the intention to treat (ITT) cohort were feasibility and effectiveness measured by weight loss and improvements in glycemic control. RESULTS 667 potential participants were screened of whom 69 (10.3%) were randomized, 30 (43.5%) with grade 1 obesity. Mean age was 47.3±6.4 years, 81% were women, and mean glycated hemoglobin was 7.9±2.0. After randomization, 7 (10%) participants refused to undergo their allocated intervention (3 RYGB, 1 LAGB, 3 LWLI) and 1 RYGB was excluded for current smoking. Twenty subjects underwent RYGB, 21 LAGB, and 20 LWLI with retention at 12 months of 90%, 86%, and 70%, respectively. In the ITT cohort with multiple imputation for missing data, RYGB participants had the greatest weight loss compared to LAGB and LWLI with average weight loss of 27%, 17%, 10% from baseline, respectively (p<.0001). Partial/complete remission of diabetes was 50%/17% in RYGB, 27%/23% in LAGB and 0%/0% in LWLI (p=.0005/.047, partial/complete) and there were significant reductions in medication usage in both surgical groups. There were no deaths and 3 serious adverse events; 1 RYGB ulcer was treated medically and 2 LAGB were re-hospitalized for dehydration. CONCLUSIONS This study highlights several potential challenges to successfully completing a larger RCT for

  7. Cardiovascular Phenotype in Patients with Heart Failure and Preserved Ejection Fraction with or without Diabetes: A RELAX Trial Ancillary Study

    PubMed Central

    Lindman, Brian R.; Dávila-Román, Victor G.; Mann, Douglas L.; McNulty, Steven; Semigran, Marc J.; Lewis, Gregory D.; de las Fuentes, Lisa; Joseph, Susan M.; Vader, Justin; Hernandez, Adrian F.; Redfield, Margaret M.

    2014-01-01

    Background RELAX was a multicenter randomized trial of sildenafil versus placebo in heart failure and preserved ejection fraction (HFpEF) with rigorous entry criteria and extensive phenotypic characterization of participants. Objectives To characterize clinical features, exercise capacity, and outcomes in patients with HFpEF with or without diabetes and gain insight into contributing pathophysiologic mechanisms. Methods RELAX enrolled 216 stable outpatients with heart failure, EF ≥50%, elevated natriuretic peptide or intracardiac pressures, and reduced exercise capacity. Prospectively collected data included echocardiography, cardiac magnetic resonance imaging, a comprehensive biomarker panel, exercise testing, and clinical events over 6 months. Results Compared with non-diabetics (n=123), diabetic (n=93) HFpEF patients were younger, more obese, more often male, and had a higher prevalence of hypertension, renal dysfunction, pulmonary disease, and vascular disease (p<0.05 for all). Uric acid, C-reactive protein, galectin-3, carboxy-terminal telopeptide of collagen type I, and endothelin-1 levels were higher in diabetics (p<0.05 for all). Diabetic patients had more ventricular hypertrophy but systolic and diastolic ventricular function parameters were similar in diabetics and non-diabetics except for a trend toward higher filling pressures (E/e′) in diabetics. Diabetics had worse maximal (peak oxygen uptake) and submaximal (6-minute walk distance) exercise capacity (p<0.01 for both). Diabetic patients were more likely to have been hospitalized for HF in the year prior to study entry (47% vs 28%, p=0.004) and had a higher incidence of cardiac or renal hospitalization at 6 months after enrollment (23.7% vs 4.9%, p<0.001). Conclusions HFpEF patients with diabetes are at increased risk of hospitalization and have reduced exercise capacity. Multi-morbidity, impaired chronotropic reserve, left ventricular hypertrophy and activation of inflammatory, pro

  8. JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial

    PubMed Central

    2010-01-01

    Background Pre-diabetes is a growing health concern where a large percentage of these patients develop full type 2 diabetes. Effective interventions on pre-diabetes can prevent or delay the occurrence or development of diabetes. Pharmaco-dynamics and pre-clinical of JinQi-Jiangtang tablets (JQJT) suggest that it could be benefit for pre-diabetes. Methods/Design Randomized controlled trial (RCT) is implemented in this study. The study term is 24 months (12 months for intervention and 12 months for follow up). Participants are recruited from four cities of China: Beijing, Tianjin, Xi'an and Nanning. Four hundred participants are randomized to treatment group (JQJT tablets) and control group (Placebo); two hundred participants each. People being included in this study must have been diagnosed as pre-diabetes via western medicine criteria and traditional Chinese medicine (TCM) criteria. The end-point indexes include: incidence of diabetes mellitus and reversion rate. Primary outcome indexes include: oral glucose tolerance test; insulin releasing test; glycosylated hemoglobin (HA1c). Secondary outcome indexes include: score of the Short Form 36 Health Survey Questionnaire (SF-36); score of TCM symptoms; blood lipid test. Indexes of safety include: general medical examination; blood and urine regular test; electrocardiogram (ECG), liver function (ALT) and renal function (BUN, Creatinine) test; record of adverse event, such as headache, faint, etc. Qualitative control will be implemented and a number of standard operating processes (SOPs) will be formed throughout the study: laboratory quality control measures; compliance control for researchers and participants; researcher training before study; supervision; investigational drug management and others. Discussion The aim of this study is to evaluate the effectiveness and safety of JinQi JiangTang (JQJT) tablets for the treatment of patients with pre-diabetes. Trial registration Chinese clinical trials register Chi

  9. Liraglutide in people treated for type 2 diabetes with multiple daily insulin injections: randomised clinical trial (MDI Liraglutide trial)

    PubMed Central

    Hirsch, Irl B; Tuomilehto, Jaakko; Dahlqvist, Sofia; Ahrén, Bo; Torffvit, Ole; Attvall, Stig; Ekelund, Magnus; Filipsson, Karin; Tengmark, Bengt-Olov; Sjöberg, Stefan; Pehrsson, Nils-Gunnar

    2015-01-01

    Study question What are the effects of liraglutide, an incretin based treatment, on glycaemic control in people with type 2 diabetes treated with multiple daily insulin injections? Methods The study was a randomised, double blind, placebo controlled trial with a parallel group design carried out at 13 hospital based outpatient clinics and one primary care unit in Sweden. Patients were considered eligible for inclusion if they had type 2 diabetes and inadequate glycaemic control (HbA1c concentrations ≥58 mmol/mol (7.5%) and ≤102 mmol/mol (11.5%)), a body mass index of 27.5-45 kg/m2, and required multiple daily insulin injections. Overall, 124 participants were randomised 1:1 to subcutaneous liraglutide or placebo by minimisation allocation. The main outcome measure was change in HbA1c level from baseline to week 24. Study answer and limitations Liraglutide was associated with a significant reduction of 16.9 mmol/mol (1.5%) in HbA1c versus 4.6 mmol/mol (0.4%) for placebo, difference −12.3 mmol/mol (95% confidence interval −15.8 to −8.8 mmol/mol; −1.13%, −1.45 to −0.81 mmol/mol). Body weight was significantly reduced in participants in the liraglutide compared with placebo group (3.8 v 0.0 kg, difference −3.8, −4.9 to −2.8 kg), and total daily insulin doses were significantly reduced, by 18.1 units and 2.3 units (difference −15.8, −23.1 to −8.5 units). Reductions in mean and standard deviation of glucose levels estimated by masked continuous glucose monitoring were significantly greater in the liraglutide group than placebo group (−1.9 and −0.5 mmol/L). Neither group experienced severe hypoglycaemic events nor were there any significant differences in symptomatic or asymptomatic non-severe hypoglycaemia (<4.0 or <3.0 mmol/L). The mean number of non-severe symptomatic hypoglycaemic events (<4.0 mmol/L) during follow-up was 1.29 in the liraglutide group and 1.24 in the placebo group (P=0.96). One of the study’s limitations was its

  10. Interpretation of cardiovascular outcome trials in type 2 diabetes needs a multiaxial approach

    PubMed Central

    Johansen, Odd Erik

    2015-01-01

    In cardiovascular (CV) diabetology a “one-size fits-all” approach needs caution as vasculopathy and CV manifestations in patients with type 2 diabetes (T2D) with short disease duration are different as compared to those with longer duration. This is of relevance when interpreting results of CV outcome trials as responses to any intervention aimed to reduce CV risk might be different in patients with established vasculopathy as compared to those without, where also the duration of the intervention may play a role. Additionally, the mode-of-action of the intervention and its assumed time to peak CV risk modulation need to be taken into account: an intervention with possibly immediate effects, like on blood pressure or other direct functional dynamic parameters such as endothelial function or renal hemodynamics, could likely provide a meaningful impact on CV outcomes over a shorter time span than interventions that primarily target pathways that work on atherosclerotic processes, organ-remodelling, or vessel integrity. We are now faced with CV outcome results to interpret from a plethora of outcomes trials in T2D, some of which are testing the CV risk modulation predominantly beyond glucose lowering, e.g., as is the case for several trials testing the newer therapy classes di-peptidyl peptidase-4 inhibitors, glucagon-like protein-1 receptor analogues and sodium glucose co-transporter-2 inhibitors, and this paper reviews the data that support a call for a multiaxial approach to interpret these results. PMID:26265995

  11. Postpartum Lifestyle Interventions to Prevent Type 2 Diabetes Among Women with History of Gestational Diabetes: A Systematic Review of Randomized Clinical Trials.

    PubMed

    Guo, Jia; Chen, Jyu-Lin; Whittemore, Robin; Whitaker, Evans

    2016-01-01

    Women with a history of gestational diabetes mellitus (GDM) are at a higher risk of developing type 2 diabetes. Several postpartum lifestyle intervention studies have been conducted for this high-risk group; however, the randomized clinical trials have not been evaluated systematically. Thus, the aim of this article is to evaluate the outcomes of clinical trials that focus on diabetes prevention among women with DGM. This systematic review utilized Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Chinese and US databases were searched. Randomized controlled trials of postpartum lifestyle interventions to prevent type 2 diabetes in women with prior GDM were reviewed. Outcomes included in this review are type 2 diabetes incidences, insulin insistence, and weight-related measures. The effect size of these outcomes in each study was computed. Data on intervention components were extracted, including type (in-person vs. technology-based), content (diet or physical activity or both), form (individual session vs. group session), duration, intensity, evaluation time point, and program delivery. A total of 12 studies met the inclusion criteria. The mean annual type 2 diabetes mellitus (T2DM) incidence of the intervention group was lower than that of the comparison group (6.0% vs. 9.3%), although there was no statistical difference between the two groups. About 50% of these studies and two-thirds of studies, respectively, reported a significant decrease in insulin resistance-related measures and weight-related measures in the intervention group compared with the comparison group. The median intervention duration and study length were 6 months. Postpartum lifestyle interventions can be effective in reducing T2DM development and insulin resistance, and decrease weight in women with GDM history, regardless of the intervention types (technology-based or in-person). Effective interventions typically include dietary changes while some physical

  12. Effects of Semelil (ANGIPARS™) on diabetic peripheral neuropathy: A randomized, double-blind Placebo-controlled clinical trial

    PubMed Central

    Bakhshayeshi, S.; Madani, SP.; Hemmatabadi, M.; Heshmat, R.; Larijani, B.

    2011-01-01

    Background and the purpose of the study Diabetic neuropathy is the most common diabetic complication that often is accompanied by significant morbidity, mortality and economic burden. The purpose of this study was evaluation of effect of Semelil (ANGIPARS™), a new herbal drug for treatment of diabetic foot ulcers or diabetic peripheral neuropathy. Methods In this double blind clinical trial, 49 type 2 diabetes patients with different degrees of neuropathy were evaluated in two groups (ANGIPARS™ and placebo groups). All patients were assessed at the start and 12 weeks after treatment, with laboratory tests, United Kingdom screening test, Michigan neuropathy screening score, Michigan diabetic neuropathy score, vibration perception thresholds, nerve conduction study, monofilament test and visual analog scale. Results Michigan diabetic neuropathy score was decreased notably in ANGIPARS™ group. In the nerve conduction study, appropriate meaningful changes were observed in the distal latency and amplitude in the motor Ulnar nerve in ANGIPARS™ group. Conclusion The results showed limited evidence of efficacy of ANGIPARS™ in diabetic neuropathy treatment and more studies with a larger sample size and longer duration are required. PMID:22615641

  13. Lessons learned from the HEALTHY primary prevention trial of risk factors for type 2 diabetes in middle school youth

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The HEALTHY trial was designed to take a primary prevention approach to risk factors for type 2 diabetes in youth, primarily obesity. The study involved over 6,000 students at 42 middle schools across the U.S. Half received an integrated intervention program of components addressing the school food ...

  14. A RANDOMIZED CONTROLLED TRIAL OF RESISTANCE EXERCISE TRAINING TO IMPROVE GLYCEMIC CONTROL IN OLDER ADULTS WITH TYPE 2 DIABETES

    Technology Transfer Automated Retrieval System (TEKTRAN)

    OBJECTIVE-To determine the efficacy of high-intensity progressive resistance training (PRT) on glycemic control in older adults with type 2 diabetes. RESEARCH DESIGN AND METHODS-We performed a 16-week randomized controlled trial in 62 Latino older adults (40 women and 22 men; mean +/- SE age 66 +/...

  15. Prevalence of Diabetes Treatment Effect Modifiers: the External Validity of Trials to Older Adults

    PubMed Central

    Weiss, Carlos O.; Boyd, Cynthia M.; Wolff, Jennifer L.; Leff, Bruce

    2012-01-01

    Background and Aims Potential treatment effect modifiers (TEMs) are specific diseases or conditions with a well-described mechanism for treatment effect modification. The prevalence of TEMs in older adults with type 2 diabetes mellitus (DM) is unknown. Objectives were to (1) determine the prevalence of pre-specified potential TEMs; (2) demonstrate the potential impact of TEMs in the older adult population using a simulated trial; (3) identify TEM combinations associated with number of hospitalizations to test construct validity. Methods Data are from the nationally-representative United States National Health and Examination Survey, 1999–2004: 8,646 Civilian, non-institutionalized adults aged 45–64 or 65+ years, including 1,443 with DM. TEMs were anemia, congestive heart failure, liver inflammation, polypharmacy, renal insufficiency, cognitive impairment, dizziness, frequent mental distress, mobility difficulty, and visual impairment. A trial was simulated to examine prevalence of potential TEM impact. The cross-sectional association between TEM patterns and number of hospitalizations was estimated to assess construct validity. Results The prevalence of TEMs was substantial such that 19.0% (95%CI: 14.8–23.2) of middle-aged adults and 38.0% (95% CI: 33.4–42.5) of older adults had any two. A simulated trial with modest levels of interaction suggested the prevalence of TEMs could nullify treatment benefit in 3.9–27.2% of older adults with DM. Compared to having DM alone, hospitalization rate was increased by several combinations of TEMs with substantial prevalence. Conclusions We provide national benchmarks that can be used to evaluate TEM prevalence reported by clinical trials of DM, and correspondingly their external validity to older adults. PMID:23238312

  16. Recruitment and Retention of Participants for an International Type 1 Diabetes Prevention Trial: A Coordinators’ Perspective

    PubMed Central

    Franciscus, Margaret; Nucci, Anita; Bradley, Brenda; Suomalainen, Heli; Greenberg, Ellen; LaForte, Diane; Kleemola, Paivi; Hyytinen, Mila; Salonen, Marja; Martin, Mary Jean; Catte, Daniel; Catteau, Jacki

    2013-01-01

    Background The Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken. A unique feature of TRIGR has been recruitment of eligible pregnant women and enrollment of newborns for long-term follow-up assessments. Purpose Our purpose is to summarize the recruitment and retention strategies used to conduct TRIGR from the perspective of the study coordinators. Methods TRIGR was designed to test whether weaning to formula containing hydrolyzed vs. intact cow’s milk protein would be efficacious in decreasing risk for development of T1D-associated autoantibodies and T1D among infants identified to be at increased risk for T1D based on their human leukocyte antigen (HLA) profile and family history. Multiple strategies tailored to local issues were required to enroll and follow the target number of infants. Results The study was conducted in the United States, Canada, Australia and 12 countries in Europe. Of the 5,606 mothers registered world-wide, 5,000 of their infants were randomized. Of these, 2,159 were HLA eligible and enrolled in the 8-month intervention and 10-year follow-up phases of the study. The TRIGR study met the accrual goal after 4.7 years of recruitment, 2.7 years longer than projected initially. Challenges included difficulty in finding fathers with T1D, a higher than expected rate of premature delivery amongst T1D mothers, and implementation of new privacy regulations mid-trial. The majority of participants were recruited from primary care antenatal clinics located near the study centers and from a general hospital or pediatric center that was affiliated with a TRIGR Study center. Internet and magazine advertisements were found to be useful for recruitment of families. Alternative follow-up strategies are offered to families who wish to reduce or discontinue participation. Limitations Our experience is limited to a single

  17. Assessing the Quality of Reports about Randomized Controlled Trials of Acupuncture Treatment on Diabetic Peripheral Neuropathy

    PubMed Central

    Yi, Guo; Zelin, Chen; Yang, Bai; Zixu, Wang; Yajun, Wang

    2012-01-01

    Background To evaluate the reports’ qualities which are about randomized controlled trials (RCTs) of acupuncture treatment on Diabetic Peripheral Neuropathy (DPN). Methodology/Principal Findings Eight databases including The Cochrane Library(1993–Sept.,2011), PubMed (1980–Sept., 2011), EMbase (1980–Sept.,2011), SCI Expanded (1998–Sept.,2011), China Biomedicine Database Disc (CBMdisc, 1978–Sept., 2011), China National Knowledge Infrastructure (CNKI, 1979–Sept., 2011 ), VIP (a full text issues database of China, 1989–Sept., 2011), Wan Fang (another full text issues database of China 1998–Sept., 2011) were searched systematically. Hand search for further references was conducted. Language was limited to Chinese and English. We identified 75 RCTs that used acupuncture as an intervention and assessed the quality of these reports with the Consolidated Standards for Reporting of Trials statement 2010 (CONSORT2010) and Standards for Reporting Interventions Controlled Trials of Acupuncture 2010(STRICTA2010). 24 articles (32%) applied the method of random allocation of sequences. No article gave the description of the mechanism of allocation concealment, no experiment applied the method of blinding. Only one article (1.47%) could be identified directly from its title as about the Randomized Controlled Trials, and only 4 articles gave description of the experimental design. No article mentioned the number of cases lost or eliminated. During one experiment, acupuncture syncope led to temporal interruption of the therapy. Two articles (2.94%) recorded the number of needles, and 8 articles (11.76%) mentioned the depth of needle insertion. None of articles reported the base of calculation of sample size, or has any analysis about the metaphase of an experiment or an explanation of its interruption. One (1.47%) mentioned intentional analysis (ITT). Conclusions/Significance The quality of the reports on RCTs of acupuncture for Diabetic Peripheral Neuropathy is

  18. Are statin trials in diabetes representative of real-world diabetes care: a population-based study on statin initiators in Finland

    PubMed Central

    Ruokoniemi, Päivi; Sund, Reijo; Arffman, Martti; Helin-Salmivaara, Arja; Huupponen, Risto; Keskimäki, Ilmo; Vehko, Tuulikki; Korhonen, Maarit Jaana

    2014-01-01

    Objective To assess the representativeness of the Heart Protection Study (HPS) and the Collaborative Atorvastatin Diabetes Study (CARDS) for incident statin users. Design A population-based analysis with linked register data. Setting Finland. Population 56 963 patients with diabetes initiating statin use from 2005 to 2008. Main outcome measures We determined the proportions of real-world patients who fulfilled the eligibility criteria for HPS and CARDS trials and assessed the cardiovascular disease (CVD) event rates, assumed to reflect the background CVD risk, for those eligible and ineligible. We used descriptive statistics to identify the patient characteristics, lipid-lowering interventions and adherence to statin therapy. Results Of the real-world patients, 57% (N=32 582) fulfilled the eligibility criteria for HPS (DM) and 49% (N=20 499) of those without CVD for CARDS. The patients ineligible for HPS (DM) had a higher cumulative risk for CVD events than those eligible, whereas regarding CARDS the cumulative risks were of similar magnitude. The overall CVD event rates seemed to be comparable to those in the reviewed trials. Both trials were under-representative of women and users of antihypertensive agents and metformin. 27% and 29% of real-world patients had an initial statin dose corresponding to <20 mg of simvastatin. The proportions of patients who were deemed adherent were 57% in the real world and 85% in both trials. Conclusions Only half of the real-world patients would have qualified for the HPS (DM) and CARDS, limiting their representativeness for clinical practice. Women and users of antihypertensive agents and metformin were under-represented in both trials. These deviations reflect the changes in diabetes treatment over the years and are not expected to modify the average treatment effects of statins on CVD. Prescribing of lower statin doses in clinical practice than used in the trials and lower adherence may, however, attenuate the benefits

  19. [ADVANCE-ON Trial; How to Achieve Maximum Reduction of Mortality in Patients With Type 2 Diabetes].

    PubMed

    Kanorskiĭ, S G

    2015-01-01

    Of 10,261 patients with type 2 diabetes who survived to the end of a randomized ADVANCE trial 83% were included in the ADVANCE-ON project for observation for 6 years. The difference in the level of blood pressure which had been achieved during 4.5 years of within trial treatment with fixed perindopril/indapamide combination quickly vanished but significant decrease of total and cardiovascular mortality in the group of patients treated with this combination for 4.5 years was sustained during 6 years of post-trial follow-up. The results can be related to gradually weakening protective effect of perindopril/indapamide combination on cardiovascular system, and are indicative of the expedience of long-term use of this antihypertensive therapy for maximal lowering of mortality of patients with diabetes. PMID:26164995

  20. Randomized Trial of Telephone Outreach to Improve Medication Adherence and Metabolic Control in Adults With Diabetes

    PubMed Central

    Schmittdiel, Julie A.; Pathak, Ram D.; Harris, Ronald I.; Newton, Katherine M.; Ohnsorg, Kris A.; Heisler, Michele; Sterrett, Andrew T.; Xu, Stanley; Dyer, Wendy T.; Raebel, Marsha A.; Thomas, Abraham; Schroeder, Emily B.; Desai, Jay R.; Steiner, John F.

    2014-01-01

    OBJECTIVE Medication nonadherence is a major obstacle to better control of glucose, blood pressure (BP), and LDL cholesterol in adults with diabetes. Inexpensive effective strategies to increase medication adherence are needed. RESEARCH DESIGN AND METHODS In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who had recently been prescribed a new class of medication for treating elevated levels of glycated hemoglobin (A1C) ≥8% (64 mmol/mol), BP ≥140/90 mmHg, or LDL cholesterol ≥100 mg/dL, to receive 1) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or 2) usual care. Hierarchical linear and logistic regression models were used to assess the impact on 1) the first medication fill within 60 days of the prescription; 2) two or more medication fills within 180 days of the prescription; and 3) clinically significant improvement in levels of A1C, BP, or LDL cholesterol. RESULTS Of the 2,378 subjects, 89.3% in the intervention group and 87.4% in the usual-care group had sufficient data to analyze study outcomes. In intent-to-treat analyses, intervention was not associated with significant improvement in primary adherence, medication persistence, or intermediate outcomes of care. Results were similar across subgroups of patients defined by age, sex, race/ethnicity, and study site, and when limiting the analysis to those who completed the intended intervention. CONCLUSIONS This low-intensity intervention did not significantly improve medication adherence or control of glucose, BP, or LDL cholesterol. Wide use of this strategy does not appear to be warranted; alternative approaches to identify and improve medication adherence and persistence are needed. PMID:25315207

  1. Connective tissue reflex massage for type 2 diabetic patients with peripheral arterial disease: randomized controlled trial.

    PubMed

    Castro-Sánchez, Adelaida María; Moreno-Lorenzo, Carmen; Matarán-Peñarrocha, Guillermo A; Feriche-Fernández-Castanys, Belen; Granados-Gámez, Genoveva; Quesada-Rubio, José Manuel

    2011-01-01

    The objective of this study was to evaluate the efficacy of connective tissue massage to improve blood circulation and intermittent claudication symptoms in type 2 diabetic patients. A randomized, placebo-controlled trial was undertaken. Ninety-eight type 2 diabetes patients with stage I or II-a peripheral arterial disease (PAD) (Leriche-Fontaine classification) were randomly assigned to a massage group or to a placebo group treated using disconnected magnetotherapy equipment. Peripheral arterial circulation was determined by measuring differential segmental arterial pressure, heart rate, skin temperature, oxygen saturation and skin blood flow. Measurements were taken before and at 30 min, 6 months and 1 year after the 15-week treatment. After the 15-week program, the groups differed (P < .05) in differential segmental arterial pressure in right lower limb (lower one-third of thigh, upper and lower one-third of leg) and left lower limb (lower one-third of thigh and upper and lower one-third of leg). A significant difference (P < .05) was also observed in skin blood flow in digits 1 and 4 of right foot and digits 2, 4 and 5 of left foot. ANOVA results were significant (P < .05) for right and left foot oxygen saturation but not for heart rate and temperature. At 6 months and 1 year, the groups differed in differential segmental arterial pressure in upper third of left and right legs. Connective tissue massage improves blood circulation in the lower limbs of type 2 diabetic patients at stage I or II-a and may be useful to slow the progression of PAD. PMID:19933770

  2. The Cross-sectional and Longitudinal Associations of Diabetic Retinopathy With Cognitive Function and Brain MRI Findings: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial

    PubMed Central

    Lovato, James F.; Ambrosius, Walter T.; Bryan, R. Nick; Gerstein, Hertzel C.; Horowitz, Karen R.; Launer, Lenore J.; Lazar, Ronald M.; Murray, Anne M.; Chew, Emily Y.; Danis, Ronald P.; Williamson, Jeff D.; Miller, Michael E.; Ding, Jingzhong

    2014-01-01

    OBJECTIVE Longitudinal evidence linking diabetic retinopathy with changes in brain structure and cognition is sparse. We used data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial to determine whether diabetic retinopathy at baseline predicted changes in brain structure or cognition 40 months later. RESEARCH DESIGN AND METHODS Participants from the ACCORD-MIND and ACCORD-Eye substudies were included in analyses of cognition (n = 1,862) and MRI-derived brain variables (n = 432). Retinopathy was categorized as none, mild nonproliferative, or moderate/severe. Tests of cognition included the Mini-Mental State Examination (MMSE), Digit Symbol Substitution Test (DSST), Rey Auditory Verbal Learning Test, and Stroop test. Primary brain outcomes were gray matter and abnormal white matter volumes. RESULTS Baseline retinopathy was associated with lower gray matter volume (adjusted means of 470, 466, and 461 cm3 for none, mild, and moderate/severe retinopathy, respectively; P = 0.03). Baseline retinopathy also predicted a greater change in MMSE and DSST scores at 40 months in each retinopathy category (MMSE: −0.20, −0.57, and −0.42, respectively [P = 0.04]; DSST: −1.30, −1.84, and −2.89, respectively[P = 0.01]). CONCLUSIONS Diabetic retinopathy is associated with future cognitive decline in people with type 2 diabetes. Although diabetic retinopathy is not a perfect proxy for diabetes-related brain and cognitive decline, patients with type 2 diabetes and retinopathy represent a subgroup at higher risk for future cognitive decline. PMID:25193529

  3. Walking away from type 2 diabetes: trial protocol of a cluster randomised controlled trial evaluating a structured education programme in those at high risk of developing type 2 diabetes

    PubMed Central

    2012-01-01

    Background The prevention of type 2 diabetes is a recognised health care priority globally. Within the United Kingdom, there is a lack of research investigating optimal methods of translating diabetes prevention programmes, based on the promotion of a healthy lifestyle, into routine primary care. This study aims to establish the behavioural and clinical effectiveness of a structured educational programme designed to target perceptions and knowledge of diabetes risk and promote a healthily lifestyle, particularly increased walking activity, in a multi-ethnic population at a high risk of developing type 2 diabetes. Design Cluster randomised controlled trial undertaken at the level of primary care practices. Follow-up will be conducted at 12, 24 and 36 months. The primary outcome is change in objectively measured ambulatory activity. Secondary outcomes include progression to type 2 diabetes, biochemical variables (including fasting glucose, 2-h glucose, HbA1c and lipids), anthropometric variables, quality of life and depression. Methods 10 primary care practices will be recruited to the study (5 intervention, 5 control). Within each practice, individuals at high risk of impaired glucose regulation will be identified using an automated version of the Leicester Risk Assessment tool. Individuals scoring within the 90th percentile in each practice will be invited to take part in the study. Practices will be assigned to either the control group (advice leaflet) or the intervention group, in which participants will be invited to attend a 3 hour structured educational programme designed to promote physical activity and a healthy lifestyle. Participants in the intervention practices will also be invited to attend annual group-based maintenance workshops and will receive telephone contact halfway between annual sessions. The study will run from 2010–2014. Discussion This study will provide new evidence surrounding the long-term effectiveness of a diabetes prevention

  4. Impact of data from recent clinical trials on strategies for treating patients with type 2 diabetes mellitus

    PubMed Central

    Palumbo, Pasquale J; Wert, Jonathan M

    2010-01-01

    Type 2 diabetes is associated with increased risk for the development of cardiovascular disease (CVD) secondary to hyperglycemia’s toxicity to blood vessels. The escalating incidence of CVD among patients with type 2 diabetes has prompted research into how lowering glycated hemoglobin (HbA1c) may improve CVD-related morbidity and mortality. Data from recent studies have shown that some patients with type 2 diabetes actually have increased mortality after achieving the lowest possible HbA1c using intensive antidiabetes treatment. Multiple factors, such as baseline HbA1c, duration of diabetes, pancreatic β-cell decline, presence of overweight/obesity, and the pharmacologic durability of antidiabetes medications influence diabetes treatment plans and therapeutic results. Hypertension and dyslipidemia are common comorbidities in patients with type 2 diabetes, which impact the risk of CVD independently of glycemic control. Consideration of all of these risk factors provides the best option for reducing morbidity and mortality in patients with type 2 diabetes. Based on the results of recent trials, the appropriate use of current antidiabetes therapies can optimize glycemic control, but use of intensive glucose-lowering therapy will need to be tailored to individual patient needs and risks. PMID:20191079

  5. Quality Randomized Clinical Trials of Topical Diabetic Foot Ulcer Healing Agents

    PubMed Central

    Bolton, Laura L.

    2016-01-01

    Significance: Diabetic foot ulcers (DFU) significantly add to global economic, social, and clinical burdens. Healing a DFU fast and well limits complications that can lead to lower extremity amputation, morbidity, and mortality. Recent Advances: Many promising topical DFU healing agents have been studied in randomized clinical trials (RCT), but only one, becaplermin, has been cleared for this use by the United States Food and Drug Administration (FDA). Critical Issues: This critical review of DFU topical healing RCTs summarizes issues identified in their design and conduct, highlighting ways to improve study quality so researchers can increase the likelihood of RCT success in propelling effective topical DFU healing agents toward clinical use. Key issues include (1) inadequate sample size, (2) risk of bias, (3) irrelevant or unreported inclusion criteria, (4) substandard outcome measures, (5) unmatched group characteristics that predict nonhealing at baseline, (6) unequal or uncontrolled concurrent interventions or standard of care, (7) heterogeneous subject or DFU samples (8) unblinded allocation, treatment, or outcome measures, or (9) inadequate follow-up for clinical relevance. These can add bias or unexplained variability to RCT outcomes, limiting clinical or statistical significance and accuracy of results. Future Directions: This critical review summarizes ways to overcome these deficiencies to optimize DFU clinical trial design and conduct. It provides a blueprint for future excellence in RCTs testing safety and efficacy of topical DFU healing agents and smoothing the path to their clinical use. PMID:26989579

  6. Pediatric Diabetic Ketoacidosis, Fluid Therapy and Cerebral Injury: The Design of a Factorial Randomized Controlled Trial

    PubMed Central

    Glaser, Nicole S.; Ghetti, Simona; Casper, T. Charles; Dean, J. Michael; Kuppermann, Nathan

    2013-01-01

    Treatment protocols for pediatric diabetic ketoacidosis (DKA) vary considerably among centers in the United States and worldwide. The optimal protocol for intravenous fluid administration is an area of particular controversy, mainly in regard to possible associations between rates of intravenous fluid infusion and the development of cerebral edema, the most common and most feared complication of DKA in children. Theoretical concerns about associations between osmotic fluid shifts and cerebral edema have prompted recommendations for conservative fluid infusion during DKA. However, recent data suggest that cerebral hypoperfusion may play a role in cerebral injury associated with DKA. Currently there are no existing data from prospective clinical trials to determine the optimal fluid treatment protocol for pediatric DKA. The Pediatric Emergency Care Applied Research Network FLUID (Fluid Therapies Under Investigation in DKA) Study is the first prospective randomized trial to evaluate fluid regimens for pediatric DKA. This 13-center nationwide factorial-design study will evaluate the effects of rehydration rate and fluid sodium content on neurological status during DKA treatment, the frequency of clinically-overt CE, and long-term neurocognitive outcomes following DKA. PMID:23490311

  7. Choice of ACE inhibitor combinations in hypertensive patients with type 2 diabetes: update after recent clinical trials

    PubMed Central

    Reboldi, Gianpaolo; Gentile, Giorgio; Angeli, Fabio; Verdecchia, Paolo

    2009-01-01

    The diabetes epidemic continues to grow unabated, with a staggering toll in micro- and macrovascular complications, disability, and death. Diabetes causes a two- to fourfold increase in the risk of cardiovascular disease, and represents the first cause of dialysis treatment both in the UK and the US. Concomitant hypertension doubles total mortality and stroke risk, triples the risk of coronary heart disease and significantly hastens the progression of microvascular complications, including diabetic nephropathy. Therefore, blood pressure reduction is of particular importance in preventing cardiovascular and renal outcomes. Successful antihypertensive treatment will often require a combination therapy, either with separate drugs or with fixed-dose combinations. Angiotensin converting enzyme (ACE) inhibitor plus diuretic combination therapy improves blood pressure control, counterbalances renin-angiotensin system activation due to diuretic therapy and reduces the risk of electrolyte alterations, obtaining at the same time synergistic antiproteinuric effects. ACE inhibitor plus calcium channel blocker provides a significant additive effect on blood pressure reduction, may have favorable metabolic effects and synergistically reduce proteinuria and the rate of decline in glomerular filtration rate, as evidenced by the GUARD trial. Finally, the recently published ACCOMPLISH trial showed that an ACE inhibitor/calcium channel blocker combination may be particularly useful in reducing cardiovascular outcomes in high-risk patients. The present review will focus on different ACE inhibitor combinations in the treatment of patients with type 2 diabetes mellitus and hypertension, in the light of recent clinical trials, including GUARD and ACCOMPLISH. PMID:19475778

  8. Randomised controlled trial of an automated, interactive telephone intervention to improve type 2 diabetes self-management (Telephone-Linked Care Diabetes Project): study protocol

    PubMed Central

    2010-01-01

    Background An estimated 285 million people worldwide have diabetes and its prevalence is predicted to increase to 439 million by 2030. For the year 2010, it is estimated that 3.96 million excess deaths in the age group 20-79 years are attributable to diabetes around the world. Self-management is recognised as an integral part of diabetes care. This paper describes the protocol of a randomised controlled trial of an automated interactive telephone system aiming to improve the uptake and maintenance of essential diabetes self-management behaviours. Methods/Design A total of 340 individuals with type 2 diabetes will be randomised, either to the routine care arm, or to the intervention arm in which participants receive the Telephone-Linked Care (TLC) Diabetes program in addition to their routine care. The intervention requires the participants to telephone the TLC Diabetes phone system weekly for 6 months. They receive the study handbook and a glucose meter linked to a data uploading device. The TLC system consists of a computer with software designed to provide monitoring, tailored feedback and education on key aspects of diabetes self-management, based on answers voiced or entered during the current or previous conversations. Data collection is conducted at baseline (Time 1), 6-month follow-up (Time 2), and 12-month follow-up (Time 3). The primary outcomes are glycaemic control (HbA1c) and quality of life (Short Form-36 Health Survey version 2). Secondary outcomes include anthropometric measures, blood pressure, blood lipid profile, psychosocial measures as well as measures of diet, physical activity, blood glucose monitoring, foot care and medication taking. Information on utilisation of healthcare services including hospital admissions, medication use and costs is collected. An economic evaluation is also planned. Discussion Outcomes will provide evidence concerning the efficacy of a telephone-linked care intervention for self-management of diabetes. Furthermore

  9. Optimal revascularization in diabetes after the FREEDOM trial: were the controversies finally settled?

    PubMed

    Tenenbaum, Alexander; Fisman, Enrique Z

    2013-01-01

    The prevalence of diabetes mellitus (DM) is growing worldwide. Prothrombotic and proinflammatory states, in adjunct to endothelial dysfunction and metabolic disorders, such as hyperglycemia, dyslipidemia, obesity, insulin resistance, and oxidative stress, are key features of the accelerated atherosclerotic progression observed in patients with DM. Moreover, drug-eluting stents (DES) thrombosis rate was higher in DM than in non-DM patients and DM itself was identifi ed as an independent predictor of stent thrombosis, particularly due to the impaired response to dual antiplatelet therapy. The accumulating data even before the FREEDOM trial provided strong evidence that in patients with DM and complex coronary artery disease, coronary artery bypass grafting (CABG) was superior to percutaneous coronary intervention (PCI) which was based on the first-generation DES. The FREEDOM trial enrolled 1900 patients with DM and multivessel coronary artery disease treated with CABG surgery or PCI with the first-generation DES. The patients were followed for a median 3.8 years; CABG was superior to PCI as it significantly reduced rates of death and myocardial infarction (MI), with a higher rate of stroke. The benefit of CABG was driven by differences in rates of both MI (p < 0.001) and death from any cause (p = 0.049). Following the FREEDOM results, patients with DM ought to be informed before coronary angiography about the potential survival benefit from CABG for the treatment of a complex disease. However, it should be noticed that the second generation DES were associated with better outcomes compared to the first-generation DES. New stent designs are continually being developed, with the aim of further improving the clinical effi cacy and the safety profile of these devices. Therefore, although the results of the FREEDOM trial clearly demonstrated that CABG was superior to PCI in DM, a comparative analysis of the new incoming stents warrants further investigation. PMID:23913450

  10. Diabetes

    MedlinePlus

    ... Diabetic retinopathy Islets of Langerhans Pancreas Insulin pump Type I diabetes Diabetic blood circulation in foot Food and insulin release ... Saunders; 2015:chap 39. Dungan KM. Management of type 2 diabetes mellitus. In: Jameson JL, De Groot LJ, de ... hyperglycemic hyperosmolar syndrome Gestational diabetes Hardening of the ...

  11. Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial

    PubMed Central

    Forster, Della A; Jacobs, Susan; Amir, Lisa H; Davis, Peter; Walker, Susan P; McEgan, Kerri; Opie, Gillian; Donath, Susan M; Moorhead, Anita M; Ford, Rachael; McNamara, Catharine; Aylward, Amanda; Gold, Lisa

    2014-01-01

    Introduction Many maternity providers recommend that women with diabetes in pregnancy express and store breast milk in late pregnancy so breast milk is available after birth, given (1) infants of these women are at increased risk of hypoglycaemia in the first 24 h of life; and (2) the delay in lactogenesis II compared with women without diabetes that increases their infant's risk of receiving infant formula. The Diabetes and Antenatal Milk Expressing (DAME) trial will establish whether advising women with diabetes in pregnancy (pre-existing or gestational) to express breast milk from 36 weeks gestation increases the proportion of infants who require admission to special or neonatal intensive care units (SCN/NICU) compared with infants of women receiving standard care. Secondary outcomes include birth gestation, breastfeeding outcomes and economic impact. Methods and analysis Women will be recruited from 34 weeks gestation to a multicentre, two arm, unblinded randomised controlled trial. The intervention starts at 36 weeks. Randomisation will be stratified by site, parity and diabetes type. Women allocated to the intervention will be taught expressing and encouraged to hand express twice daily for 10 min and keep an expressing diary. The sample size of 658 (329 per group) will detect a 10% difference in proportion of babies admitted to SCN/NICU (85% power, α 0.05). Data are collected at recruitment (structured questionnaire), after birth (abstracted from medical record blinded to group), and 2 and 12 weeks postpartum (telephone interview). Data analysis: the intervention group will be compared with the standard care group by intention to treat analysis, and the primary outcome compared using χ2 and ORs. Ethics and dissemination Research ethics approval will be obtained from participating sites. Results will be published in peer-reviewed journals and presented to clinicians, policymakers and study participants. Trial registration number Australian

  12. Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA®)

    PubMed Central

    Rosenstock, Julio; Kahn, Steven E; Zinman, Bernard; Kastelein, John J; Lachin, John M; Espeland, Mark A; Bluhmki, Erich; Mattheus, Michaela; Ryckaert, Bart; Patel, Sanjay; Johansen, Odd Erik; Woerle, Hans-Juergen

    2015-01-01

    CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (NCT01243424) is an ongoing, randomized trial in subjects with early type 2 diabetes and increased cardiovascular risk or established complications that will determine the long-term cardiovascular impact of linagliptin versus the sulphonylurea glimepiride. Eligible patients were sulphonylurea-naïve with HbA1c 6.5%–8.5% or previously exposed to sulphonylurea (in monotherapy or in a combination regimen <5 years) with HbA1c 6.5%–7.5%. Primary outcome is time to first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina. A total of 631 patients with primary outcome events will be required to provide 91% power to demonstrate non-inferiority in cardiovascular safety by comparing the upper limit of the two-sided 95% confidence interval as being below 1.3 for a given hazard ratio. Hierarchical testing for superiority will follow, and the trial has 80% power to demonstrate a 20% relative cardiovascular risk reduction. A total of 6041 patients were treated with median type 2 diabetes duration 6.2 years, 40.0% female, mean HbA1c 7.2%, 66% on 1 and 24% on 2 glucose-lowering agents and 34.5% had previous cardiovascular complications. The results of CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes may influence the decision-making process for selecting a second glucose-lowering agent after metformin in type 2 diabetes. PMID:25780262

  13. A translational worksite diabetes prevention trial improves psychosocial status, dietary intake, and step counts among employees with prediabetes: A randomized controlled trial

    PubMed Central

    Miller, Carla K.; Weinhold, Kellie R.; Marrero, David G.; Nagaraja, Haikady N.; Focht, Brian C.

    2015-01-01

    Objective Few worksite trials have examined the impact of diabetes prevention interventions on psychological and behavioral outcomes. Thus, the impact of a worksite lifestyle intervention on psychosocial outcomes, food group intake, and step counts for physical activity (PA) was evaluated. Method A randomized pretest/posttest control group design with 3-month follow-up was employed from October 2012 to May 2014 at a U.S. university worksite among employees with prediabetes. The experimental group (n = 35) received a 16-week group-based intervention while the control group received usual care (n = 33). Repeated measures analysis of variance compared the change in outcomes between groups across time. Results A significant difference occurred between groups post-intervention for self-efficacy associated with eating and PA; goal commitment and difficulty; satisfaction with weight loss and physical fitness; peer social support for healthful eating; generation of alternatives for problem solving; and intake of fruits, meat, fish, poultry, nuts, and seeds (all ps < .05). The experimental group significantly increased step counts post-intervention (p = .0279) and were significantly more likely to report completing their work at study end (p = .0231). Conclusion The worksite trial facilitated improvement in modifiable psychosocial outcomes, dietary patterns, and step counts; the long-term impact on diabetes prevention warrants further investigation. Trial Registration ClinicalTrials.gov identifier: NCT01682954 PMID:25798374

  14. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial and Hurricane Katrina: lessons for managing clinical trials during and after a natural disaster.

    PubMed

    McDuffie, Roberta; Summerson, John; Reilly, Patricia; Blackwell, Caroline; Goff, David; Kimel, Angela R; Crago, Lenore; Fonseca, Vivian

    2008-09-01

    Hurricane Katrina was one of the most catastrophic natural disasters to hit the United States. It had a major impact on health care in New Orleans, LA and the surrounding region, not only in relation to acute illness but also chronic disease. When Hurricane Katrina struck New Orleans on August 29, 2005, there were 193 participants being followed in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial at Tulane University Health Sciences Center. In the immediate aftermath of the storm, the Tulane University ACCORD Study site, in collaboration with the Study Coordinating Center and the Southeast Clinical Center Network office of the trial at Wake Forest University Health Sciences in North Carolina, took several actions in order to locate the participants, ensure their safety, and maintain the scientific integrity of the trial. We describe the actions taken and the relative success/failure of such actions. PMID:18577469

  15. A cluster randomised pragmatic trial applying Self-determination theory to type 2 diabetes care in general practice

    PubMed Central

    2011-01-01

    Background Treatment recommendations for prevention of type 2 diabetes complications often require radical and life-long health behaviour changes. Observational studies based on Self-determination theory (SDT) propose substantial factors for the maintenance of behaviour changes and concomitant well-being, but experimental research is needed to develop and evaluate SDT-based interventions. The aims of this paper were to describe 1) the design of a trial assessing the effectiveness of a training course for practice-nurses in autonomy support on patient-perceived motivation, HbA1, cholesterol, and well-being among a diabetes population, 2) the actual intervention to a level of detail that allows its replication, and 3) the connection between SDT recommendations for health care-provider behaviour and the content of the training course. Methods/Design The study is a cluster-randomised pragmatic trial including 40 Danish general practices with nurse-led diabetes consultations, and the associated diabetes population. The diabetes population was identified by registers (n = 4034). The intervention was a 16-hour course with interactive training for practice nurses. The course was delivered over 4 afternoons at Aarhus University and one 1/2 hour visit to the practice by one of the course-teachers over a period of 10 months (0, 2, 5, 10 mths.). The intervention is depicted by a PaT Plot showing the timeline and the characteristics of the intervention components. Effectiveness of the intervention will be assessed on the diabetes populations with regard to well-being (PAID, SF-12), HbA1c- and cholesterol-levels, perceived autonomy support (HCCQ), type of motivation (TSRQ), and perceived competence for diabetes care (PCD) 15-21 months after the core course; the completion of the second course afternoon. Data will be retrieved from registers and by questionnaires. Discussion Challenges and advantages of the pragmatic design are discussed. In a real-world setting, this study will

  16. Benchmarking in Student Affairs.

    ERIC Educational Resources Information Center

    Mosier, Robert E.; Schwarzmueller, Gary J.

    2002-01-01

    Discusses the use of benchmarking in student affairs, focusing on issues related to student housing. Provides examples of how benchmarking has influenced administrative practice at many institutions. (EV)

  17. Effect of pharmacist-led patient education on glycemic control of type 2 diabetics: a randomized controlled trial

    PubMed Central

    Farsaei, Shadi; Sabzghabaee, Ali Mohammad; Zargarzadeh, Amir Hooshang; Amini, Massoud

    2011-01-01

    BACKGROUND: This study was conducted to evaluate the effect of a clinical pharmacist-led patient education program for type 2 diabetic patients at Isfahan Endocrine & Metabolism Research Center (IEMRC) from April 2008 to January 2009. METHODS: In a randomized controlled clinical trial, a total of 172 patients with uncontrolled type 2 diabetes were selected and randomly allocated into control and intervention groups. After taking informed written consent, the intervention group received an educational program about oral anti-hyperglycemic medications, adherence, diabetes dairy log and pill box usage. Patient's glycemic control in the intervention group was followed for three months through either telephone or face to face interviews with the pharmacist. Fasting blood glucose and HbA1c were measured at the start and end of the pharmacistled drug education program for both intervention and control groups. RESULTS: After a three months follow-up, mean fasting blood glucose and HbA1c of the patients in the intervention group decreased significantly compared to control group (p < 0.001). CONCLUSIONS: This study demonstrates an improvement in diabetes management of type 2 diabetics by involving a pharmacist in the multidisciplinary teams in the outpatient clinics. The results suggest the benefits of adding adherence education to the diabetic education programs. PMID:21448382

  18. Targeting intensive versus conventional glycaemic control for type 1 diabetes mellitus: a systematic review with meta-analyses and trial sequential analyses of randomised clinical trials

    PubMed Central

    Kähler, Pernille; Grevstad, Berit; Almdal, Thomas; Gluud, Christian; Wetterslev, Jørn; Vaag, Allan; Hemmingsen, Bianca

    2014-01-01

    Objective To assess the benefits and harms of targeting intensive versus conventional glycaemic control in patients with type 1 diabetes mellitus. Design A systematic review with meta-analyses and trial sequential analyses of randomised clinical trials. Data sources The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded and LILACS to January 2013. Study selection Randomised clinical trials that prespecified different targets of glycaemic control in participants at any age with type 1 diabetes mellitus were included. Data extraction Two authors independently assessed studies for inclusion and extracted data. Results 18 randomised clinical trials included 2254 participants with type 1 diabetes mellitus. All trials had high risk of bias. There was no statistically significant effect of targeting intensive glycaemic control on all-cause mortality (risk ratio 1.16, 95% CI 0.65 to 2.08) or cardiovascular mortality (0.49, 0.19 to 1.24). Targeting intensive glycaemic control reduced the relative risks for the composite macrovascular outcome (0.63, 0.41 to 0.96; p=0.03), and nephropathy (0.37, 0.27 to 0.50; p<0.00001. The effect estimates of retinopathy, ketoacidosis and retinal photocoagulation were not consistently statistically significant between random and fixed effects models. The risk of severe hypoglycaemia was significantly increased with intensive glycaemic targets (1.40, 1.01 to 1.94). Trial sequential analyses showed that the amount of data needed to demonstrate a relative risk reduction of 10% were, in general, inadequate. Conclusions There was no significant effect towards improved all-cause mortality when targeting intensive glycaemic control compared with conventional glycaemic control. However, there may be beneficial effects of targeting intensive glycaemic control on the composite macrovascular outcome and on nephropathy, and detrimental effects on severe hypoglycaemia. Notably, the data for retinopathy and ketoacidosis were inconsistent

  19. The effect of the Talking Diabetes consulting skills intervention on glycaemic control and quality of life in children with type 1 diabetes: cluster randomised controlled trial (DEPICTED study)

    PubMed Central

    McNamara, Rachel; Bennert, Kristina; Butler, Christopher C; Channon, Sue; Cohen, David; Crowne, Elizabeth; Hambly, Helen; Hawthorne, Kamila; Hood, Kerenza; Longo, Mirella; Lowes, Lesley; Pickles, Tim; Playle, Rebecca; Rollnick, Stephen; Thomas-Jones, Emma; Gregory, John W

    2012-01-01

    Objective To evaluate the effectiveness on glycaemic control of a training programme in consultation skills for paediatric diabetes teams. Design Pragmatic cluster randomised controlled trial. Setting 26 UK secondary and tertiary care paediatric diabetes services. Participants 79 healthcare practitioners (13 teams) trained in the intervention (359 young people with type 1 diabetes aged 4-15 years and their main carers) and 13 teams allocated to the control group (334 children and their main carers). Intervention Talking Diabetes programme, which promotes shared agenda setting and guiding communication style, through flexible menu of consultation strategies to support patient led behaviour change. Main outcome measures The primary outcome was glycated haemoglobin (HbA1c) level one year after training. Secondary outcomes were clinical measures (hypoglycaemic episodes, body mass index, insulin regimen), general and diabetes specific quality of life, self reported and proxy reported self care and enablement, perceptions of the diabetes team, self reported and carer reported importance of, and confidence in, undertaking diabetes self management measured over one year. Analysis was by intention to treat. An integrated process evaluation included audio recording a sample of 86 routine consultations to assess skills shortly after training (intervention group) and at one year follow-up (intervention and control group). Two key domains of skill assessment were use of the guiding communication style and shared agenda setting. Results 660/693 patients (95.2%) provided blood samples at follow-up. Training diabetes care teams had no effect on HbA1c levels (intervention effect 0.01, 95% confidence interval −0.02 to 0.04, P=0.5), even after adjusting for age and sex of the participants. At follow-up, trained staff (n=29) were more capable than controls (n=29) in guiding (difference in means 1.14, P<0.001) and agenda setting (difference in proportions 0.45, 95% confidence

  20. Spinal cord stimulation in patients with painful diabetic neuropathy: a multicentre randomized clinical trial.

    PubMed

    de Vos, Cecile C; Meier, Kaare; Zaalberg, Paul Brocades; Nijhuis, Harold J A; Duyvendak, Wim; Vesper, Jan; Enggaard, Thomas P; Lenders, Mathieu W P M

    2014-11-01

    Painful diabetic neuropathy (PDN) is a peripheral neuropathic pain condition that is often difficult to relieve. Spinal cord stimulation (SCS) is a proven effective therapy for various types of mixed neuropathic conditions, yet effectiveness of SCS treatment for PDN is not well established. To our knowledge, ours is the first multicentre randomized controlled trial investigating the effectiveness of SCS in patients with PDN. Sixty patients with PDN in the lower extremities refractory to conventional medical therapy were enrolled and followed for 6 months. They were randomized 2:1 to best conventional medical practice with (SCS group) or without (control group) additional SCS therapy, and both groups were assessed at regular intervals. At each follow-up visit, the EuroQoL 5D, the short form McGill Pain Questionnaire (SF-MPQ) and a visual analogue scale (VAS, ranging 0-100) to measure pain intensity were recorded. The average VAS score for pain intensity was 73 in the SCS group and 67 in the control group at baseline. After 6 months of treatment, the average VAS score was significantly reduced to 31 in the SCS group (P<.001) and remained 67 (P=.97) in the control group. The SF-MPQ and EuroQoL 5D questionnaires also showed that patients in the SCS group, unlike those in the control group, experienced reduced pain and improved health and quality of life after 6 months of treatment. In patients with refractory painful diabetic neuropathy, spinal cord stimulation therapy significantly reduced pain and improved quality of life. PMID:25180016

  1. Randomized control trial of topical clonidine for treatment of painful diabetic neuropathy

    PubMed Central

    Campbell, Claudia M.; Kipnes, Mark S.; Stouch, Bruce C.; Brady, Kerrie L.; Kelly, Margaret; Schmidt, William K.; Petersen, Karin L.; Rowbotham, Michael C.; Campbell, James N.

    2012-01-01

    A length-dependent neuropathy with pain in the feet is a common complication of diabetes (painful diabetic neuropathy, PDN). It was hypothesized that pain may arise from sensitized-hyperactive cutaneous nociceptors, and that this abnormal signaling may be reduced by topical administration of the α2-adrenergic agonist, clonidine, to the painful area. This was a randomized, double-blind, placebo-controlled, parallel-group, multi-center trial. Nociceptor function was measured by determining the painfulness of 0.1% topical capsaicin applied to the pre-tibial area of each subject for 30 minutes during screening. Subjects were then randomized to receive 0.1% topical clonidine gel (n=89) or placebo gel (n=90) applied t.i.d. to their feet for 12 weeks. The difference in foot pain at week 12 in relation to baseline, rated on a 0-10 numerical pain rating scale (NPRS), was compared between groups. Baseline NPRS was imputed for missing data for subjects who terminated the study early. The subjects treated with clonidine showed a trend toward decreased foot pain compared to the placebo-treated group (the primary endpoint; p=0.07). In subjects who felt any level of pain to capsaicin, clonidine was superior to placebo (p<0.05). In subjects with a capsaicin pain rating ≥2 (0-10, NPRS), the mean decrease in foot pain was 2.6 for active compared to 1.4 for placebo (p=0.01). Topical clonidine gel significantly reduces the level of foot pain in PDN subjects with functional (and possibly sensitized) nociceptors in the affected skin as revealed by testing with topical capsaicin. Screening for cutaneous nociceptor function may help distinguish candidates for topical therapy for neuropathic pain. PMID:22683276

  2. A randomized controlled clinical trial of vildagliptin plus metformin combination therapy in patients with type II diabetes mellitus

    PubMed Central

    SU, YONG; SU, YA-LI; LV, LI-FANG; WANG, LI-MIN; LI, QUAN-ZHONG; ZHAO, ZHI-GANG

    2014-01-01

    The aim of the present study was to assess the efficacy and safety of vildagliptin plus metformin combination therapy in patients with type II diabetes mellitus. Type II diabetic patients with poor glycemic control following at least three months of metformin treatment were selected and randomized into two groups. Vildagliptin or placebo was administered with metformin. Body weight, fasting blood glucose (FBG), postprandial glucose (PPG), glycated hemoglobin (HbA1c), blood lipid and hepatorenal function levels were analyzed in the patients prior to and 24-weeks after the trial. FBG, PPG and HbA1c levels of the patients in the vildagliptin group significantly decreased following the trial, whereas no statistically significant differences were observed in the various indicators of the placebo group prior to and following the trial. The FBG, PPG and HbA1c levels in the vildagliptin group were significantly lower compared with the placebo group 24-weeks after the trial. Comparisons of body weight, blood lipid and hepatorenal function between the groups prior to and following the trial exhibited no statistically significant differences. Therefore, vildagliptin plus metformin combination therapy effectively reduced FBG, PPG and HbA1c levels in patients with no risk of weight gain or hepatorenal dysfunction. PMID:24669235

  3. Rationale and study design for a randomised controlled trial to reduce sedentary time in adults at risk of type 2 diabetes mellitus: project stand (Sedentary Time ANd diabetes)

    PubMed Central

    2011-01-01

    Background The rising prevalence of Type 2 Diabetes Mellitus (T2DM) is a major public health problem. There is an urgent need for effective lifestyle interventions to prevent the development of T2DM. Sedentary behaviour (sitting time) has recently been identified as a risk factor for diabetes, often independent of the time spent in moderate-to-vigorous physical activity. Project STAND (Sedentary Time ANd Diabetes) is a study which aims to reduce sedentary behaviour in younger adults at high risk of T2DM. Methods/Design A reduction in sedentary time is targeted using theory driven group structured education. The STAND programme is subject to piloting and process evaluation in line with the MRC framework for complex interventions. Participants are encouraged to self-monitor and self-regulate their behaviour. The intervention is being assessed in a randomised controlled trial with 12 month follow up. Inclusion criteria are a) aged 18-40 years with a BMI in the obese range; b) 18-40 years with a BMI in the overweight range plus an additional risk factor for T2DM. Participants are randomised to the intervention (n = 89) or control (n = 89) arm. The primary outcome is a reduction in sedentary behaviour at 12 months as measured by an accelerometer (count < 100/min). Secondary outcomes include physical activity, sitting/lying time using the ActivPAL posture monitor, fasting and 2 h oral glucose tolerance test, lipids, inflammatory biomarkers, body weight, waist circumference, blood pressure, illness perceptions, and efficacy beliefs for behaviour change. Conclusions This is the first UK trial to address sedentary behaviour change in a population of younger adults at risk of T2DM. The results will provide a platform for the development of a range of future multidisciplinary interventions in this rapidly expanding high-risk population. Trial registration Current controlled trials ISRCTN08434554, MRC project 91409. PMID:22151909

  4. Telemonitoring and Mobile Phone-Based Health Coaching Among Finnish Diabetic and Heart Disease Patients: Randomized Controlled Trial

    PubMed Central

    Karhula, Tuula; Rääpysjärvi, Katja; Pakanen, Mira; Itkonen, Pentti; Tepponen, Merja; Junno, Ulla-Maija; Jokinen, Tapio; van Gils, Mark; Lähteenmäki, Jaakko; Kohtamäki, Kari; Saranummi, Niilo

    2015-01-01

    Background There is a strong will and need to find alternative models of health care delivery driven by the ever-increasing burden of chronic diseases. Objective The purpose of this 1-year trial was to study whether a structured mobile phone-based health coaching program, which was supported by a remote monitoring system, could be used to improve the health-related quality of life (HRQL) and/or the clinical measures of type 2 diabetes and heart disease patients. Methods A randomized controlled trial was conducted among type 2 diabetes patients and heart disease patients of the South Karelia Social and Health Care District. Patients were recruited by sending invitations to randomly selected patients using the electronic health records system. Health coaches called patients every 4 to 6 weeks and patients were encouraged to self-monitor their weight, blood pressure, blood glucose (diabetics), and steps (heart disease patients) once per week. The primary outcome was HRQL measured by the Short Form (36) Health Survey (SF-36) and glycosylated hemoglobin (HbA1c) among diabetic patients. The clinical measures assessed were blood pressure, weight, waist circumference, and lipid levels. Results A total of 267 heart patients and 250 diabetes patients started in the trial, of which 246 and 225 patients concluded the end-point assessments, respectively. Withdrawal from the study was associated with the patients’ unfamiliarity with mobile phones—of the 41 dropouts, 85% (11/13) of the heart disease patients and 88% (14/16) of the diabetes patients were familiar with mobile phones, whereas the corresponding percentages were 97.1% (231/238) and 98.6% (208/211), respectively, among the rest of the patients (P=.02 and P=.004). Withdrawal was also associated with heart disease patients’ comorbidities—40% (8/20) of the dropouts had at least one comorbidity, whereas the corresponding percentage was 18.9% (47/249) among the rest of the patients (P=.02). The intervention showed

  5. Four-year analysis of cardiovascular disease risk factors, depression symptoms, and antidepressant medicine use in the Look AHEAD (Action for Health in Diabetes) clinical trial of weight loss in diabetes

    Technology Transfer Automated Retrieval System (TEKTRAN)

    OBJECTIVE To study the association of depressive symptoms or antidepressant medicine (ADM) use with subsequent cardiovascular disease (CVD) risk factor status in the Look AHEAD (Action for Health in Diabetes) trial of weight loss in type 2 diabetes. RESEARCH DESIGN AND METHODS Participants (n = 5,1...

  6. In-Silico Trials for Glucose Control in Hospitalized Patients with Type 2 Diabetes.

    PubMed

    Choi, Karam; Oh, Tae Jung; Lee, Jung Chan; Kim, Myungjoon; Kim, Hee Chan; Cho, Young Min; Kim, Sungwan

    2016-02-01

    Although various basal-bolus insulin therapy (BBIT) protocols have been used in the clinical environment, safer and more effective BBIT protocols are required for glucose control in hospitalized patients with type 2 diabetes (T2D). Modeling approaches could provide an evaluation environment for developing the optimal BBIT protocol prior to clinical trials at low cost and without risk of danger. In this study, an in-silico model was proposed to evaluate subcutaneous BBIT protocols in hospitalized patients with T2D. The proposed model was validated by comparing the BBIT protocol and sliding-scale insulin therapy (SSIT) protocol. The model was utilized for in-silico trials to compare the protocols of adjusting basal-insulin dose (BBIT1) versus adjusting total-daily-insulin dose (BBIT2). The model was also used to evaluate two different initial total-daily-insulin doses for various levels of renal function. The BBIT outcomes were superior to those of SSIT, which is consistent with earlier studies. BBIT2 also outperformed BBIT1, producing a decreased daily mean glucose level and longer time-in-target-range. Moreover, with a standard dose, the overall daily mean glucose levels reached the target range faster than with a reduced-dose for all degrees of renal function. The in-silico studies demonstrated several significant findings, including that the adjustment of total-daily-insulin dose is more effective than changes to basal-insulin dose alone. This research represents a first step toward the eventual development of an advanced model for evaluating various BBIT protocols. PMID:26839477

  7. In-Silico Trials for Glucose Control in Hospitalized Patients with Type 2 Diabetes

    PubMed Central

    2016-01-01

    Although various basal-bolus insulin therapy (BBIT) protocols have been used in the clinical environment, safer and more effective BBIT protocols are required for glucose control in hospitalized patients with type 2 diabetes (T2D). Modeling approaches could provide an evaluation environment for developing the optimal BBIT protocol prior to clinical trials at low cost and without risk of danger. In this study, an in-silico model was proposed to evaluate subcutaneous BBIT protocols in hospitalized patients with T2D. The proposed model was validated by comparing the BBIT protocol and sliding-scale insulin therapy (SSIT) protocol. The model was utilized for in-silico trials to compare the protocols of adjusting basal-insulin dose (BBIT1) versus adjusting total-daily-insulin dose (BBIT2). The model was also used to evaluate two different initial total-daily-insulin doses for various levels of renal function. The BBIT outcomes were superior to those of SSIT, which is consistent with earlier studies. BBIT2 also outperformed BBIT1, producing a decreased daily mean glucose level and longer time-in-target-range. Moreover, with a standard dose, the overall daily mean glucose levels reached the target range faster than with a reduced-dose for all degrees of renal function. The in-silico studies demonstrated several significant findings, including that the adjustment of total-daily-insulin dose is more effective than changes to basal-insulin dose alone. This research represents a first step toward the eventual development of an advanced model for evaluating various BBIT protocols. PMID:26839477

  8. A Meta-Analysis of Randomized Controlled Trials of Yiqi Yangyin Huoxue Method in Treating Diabetic Nephropathy.

    PubMed

    Ou, Jiao Ying; Huang, Di; Wu, Yan Sheng; Xu, Lin; He, Fei; Wang, Hui Ling; Shi, Li Qiang; Wan, Qiang; He, Li Qun; Dong Gao, Jian

    2016-01-01

    Objective. The purpose of this systematic review is to evaluate the evidence of Yiqi Yangyin Huoxue Method for diabetic nephropathy. Methods. 11 electronic databases, through September 2015, were searched to identify randomized controlled trials of Yiqi Yangyin Huoxue Method for diabetic nephropathy. The quality of the included trials was assessed using the Jadad scale. Results. 26 randomized controlled trials were included in our review. Of all the included trials, most of them were considered as high quality. The aggregated results suggested that Yiqi Yangyin Huoxue Method is beneficial to diabetic nephropathy in bringing down the microalbuminuria (SMD = -0.98, 95% CI -1.22 to -0.74), serum creatinine (SMD = -0.56, 95% CI -0.93 to -0.20), beta-2 microglobulin (MD = 0.06, 95% CI 0.01 to 0.12), fasting plasma glucose (MD = -0.35, 95% CI -0.62 to -0.08), and 2-hour postprandial blood glucose (MD = 1.13, 95% CI 0.07 to 2.20), but not in decreasing blood urea nitrogen (SMD = -0.72, 95% CI -1.47 to 0.02) or 2-hour postprandial blood glucose (SMD = -0.48, 95% CI -1.01 to 0.04). Conclusions. Yiqi Yangyin Huoxue Method should be a valid complementary and alternative therapy in the management of diabetic nephropathy, especially in improving UAER, serum creatinine, fasting blood glucose, and beta-2 microglobulin. However, more studies with long follow-up are warrant to confirm the current findings. PMID:27313643

  9. A Meta-Analysis of Randomized Controlled Trials of Yiqi Yangyin Huoxue Method in Treating Diabetic Nephropathy

    PubMed Central

    Ou, Jiao Ying; Huang, Di; Wu, Yan Sheng; Xu, Lin; He, Fei; Wang, Hui Ling; Shi, Li Qiang; Wan, Qiang; He, Li Qun; Dong Gao, Jian

    2016-01-01

    Objective. The purpose of this systematic review is to evaluate the evidence of Yiqi Yangyin Huoxue Method for diabetic nephropathy. Methods. 11 electronic databases, through September 2015, were searched to identify randomized controlled trials of Yiqi Yangyin Huoxue Method for diabetic nephropathy. The quality of the included trials was assessed using the Jadad scale. Results. 26 randomized controlled trials were included in our review. Of all the included trials, most of them were considered as high quality. The aggregated results suggested that Yiqi Yangyin Huoxue Method is beneficial to diabetic nephropathy in bringing down the microalbuminuria (SMD = −0.98, 95% CI −1.22 to −0.74), serum creatinine (SMD = −0.56, 95% CI −0.93 to −0.20), beta-2 microglobulin (MD = 0.06, 95% CI 0.01 to 0.12), fasting plasma glucose (MD = −0.35, 95% CI −0.62 to −0.08), and 2-hour postprandial blood glucose (MD = 1.13, 95% CI 0.07 to 2.20), but not in decreasing blood urea nitrogen (SMD = −0.72, 95% CI −1.47 to 0.02) or 2-hour postprandial blood glucose (SMD = −0.48, 95% CI −1.01 to 0.04). Conclusions. Yiqi Yangyin Huoxue Method should be a valid complementary and alternative therapy in the management of diabetic nephropathy, especially in improving UAER, serum creatinine, fasting blood glucose, and beta-2 microglobulin. However, more studies with long follow-up are warrant to confirm the current findings. PMID:27313643

  10. Midcourse correction to a clinical trial when the event rate is underestimated: The Look AHEAD (Action of health in diabetes) study

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The Look AHEAD (Action for Health in Diabetes) Study is a long-term clinical trial that aims to determine the cardiovascular disease (CVD) benefits of an intensive lifestyle intervention (ILI) in obese adults with type 2 diabetes. The study was designed to have 90% statistical power to detect an 18%...

  11. Alterations in left ventricular, left atrial, and right ventricular structure and function to cardiovascular risk factors in adolescents with type 2 diabetes participating in the TODAY clinical trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Data on cardiovascular disease (CVD) risk in adolescents with type 2 diabetes (T2D) are limited. Echocardiography was performed in the last year of the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial (median 4.5 yr from diagnosis of T2D, average age 18 yr), incl...

  12. Effect of 1 year of an intentional weight loss intervention on bone mineral density in type 2 diabetes: Results from the Look AHEAD randomized trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Intentional weight loss is an important component of treatment for overweight patients with type 2 diabetes, but the effects on bone density are not known. We used data from the Look AHEAD trial to determine the impact of an intensive lifestyle weight loss intervention (ILI) compared with diabetes s...

  13. Testing a peer support intervention for people with type 2 diabetes: a pilot for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background People with Type 2 diabetes face various psycho-social, self-management and clinical care issues and evidence is mixed whether support from others with diabetes, ‘peer support’, can help. We now describe a 2 month pilot study of different peer support interventions. Methods The intervention was informed by formative evaluation using semi-structured interviews with health professionals, community support groups and observation of diabetes education and support groups. Invitations to participate were mailed from 4 general practices and included a survey of barriers to care. Participants were randomized by practice to receive individual, group, combined (both individual and group) or no peer support. Evaluation included ethnographic observation, semi-structured interviews and questionnaires at baseline and post-intervention. Results Of 1,101 invited, 15% expressed an interest in participating in the pilot. Sufficient numbers volunteered to become peer supporters, although 50% of these (8/16) withdrew. Those in the pilot were similar to other patients, but were less likely to feel they knew enough about diabetes (60.8% vs 44.6% p = 0.035) and less likely to be happy with the diabetes education/care to date (75.4% vs 55.4% p = 0.013). Key issues identified were the need to recruit peer supporters directly rather than through clinicians, to address participant diabetes educational needs early and the potential for group sessions to have lower participation rates than 1:1 sessions. Conclusions Recruitment to a full trial of peer support within the existing study design is feasible with some amendments. Attendance emerged as a key issue needing close monitoring and additional intervention during the trial. PMID:23297781

  14. Mexican American Trial of Community Health Workers: A Randomized Controlled Trial of a Community Health Worker Intervention for Mexican Americans With Type 2 Diabetes Mellitus

    PubMed Central

    Martin, Molly A.; Swider, Susan M.; Tumialán Lynas, Carmen M.; Janssen, Imke; Avery, Elizabeth F.; Powell, Lynda H.

    2014-01-01

    Objectives. We assessed whether community health workers (CHWs) could improve glycemic control among Mexican Americans with diabetes. Methods. We recruited 144 Mexican Americans with type 2 diabetes between January 2006 and September 2008 into the single-blinded, randomized controlled Mexican American Trial of Community Health Workers (MATCH) and followed them for 2 years. Participants were assigned to either a CHW intervention, delivering self-management training through 36 home visits over 2 years, or a bilingual control newsletter delivering the same information on the same schedule. Results. Intervention participants showed significantly lower hemoglobin A1c levels than control participants at both year 1 Δ = −0.55; P = .021) and year 2 (Δ = −0.69; P = .005). We observed no effect on blood pressure control, glucose self-monitoring, or adherence to medications or diet. Intervention participants increased physical activity from a mean of 1.63 days per week at baseline to 2.64 days per week after 2 years. Conclusions. A self-management intervention delivered by CHWs resulted in sustained improvements in glycemic control over 2 years among Mexican Americans with diabetes. MATCH adds to the growing body of evidence supporting the use of CHWs to reduce diabetes-related health disparities. PMID:23947316

  15. Methodological Reporting Quality of Randomized Controlled Trials in 3 Leading Diabetes Journals From 2011 to 2013 Following CONSORT Statement: A System Review.

    PubMed

    Zhai, Xiao; Wang, Yiran; Mu, Qingchun; Chen, Xiao; Huang, Qin; Wang, Qijin; Li, Ming

    2015-07-01

    To appraise the current reporting methodological quality of randomized clinical trials (RCTs) in 3 leading diabetes journals.We systematically searched the literature for RCTs in Diabetes Care, Diabetes and Diabetologia from 2011 to 2013.Characteristics were extracted based on Consolidated Standards of Reporting Trials (CONSORT) statement. Generation of allocation, concealment of allocation, intention-to-treat (ITT) analysis and handling of dropouts were defined as primary outcome and "low risk of bias." Sample size calculation, type of intervention, country, number of patients, funding source were also revealed and descriptively reported. Trials were compared among journals, study years, and other characters.A total of 305 RCTs were enrolled in this study. One hundred eight (35.4%) trials reported adequate generation of allocation, 87 (28.5%) trials reported adequate concealment of allocation, 53 (23.8%) trials used ITT analysis, and 130 (58.3%) trials were adequate in handling of dropouts. Only 15 (4.9%) were "low risk of bias" trials. Studies at a large scale (n > 100) or from European presented with more "low risk of bias" trials than those at a small scale (n ≤ 100) or from other regions. No improvements were found in these 3 years.This study shows that methodological reporting quality of RCTs in the major diabetes journals remains suboptimal. It can be further improved to meet and keep up with the standards of the CONSORT statement. PMID:26166088

  16. Exercise intervention in New Zealand Polynesian peoples with type 2 diabetes: Cultural considerations and clinical trial recommendations

    PubMed Central

    Sukala, William R.; Page, Rachel A.; Rowlands, David S.; Lys, Isabelle; Krebs, Jeremy D.; Leikis, Murray J.; Cheema, Birinder S.

    2012-01-01

    The Maori and Pacific Islands peoples of New Zealand suffer a greater burden of type 2 diabetes mellitus (T2DM) and associated comorbidities than their European counterparts. Empirical evidence supports the clinical application of aerobic and resistance training for effective diabetes management and potential remission, but few studies have investigated the effectiveness of these interventions in specific ethnic cohorts. We recently conducted the first trial to investigate the effect of prescribed exercise training in Polynesian people with T2DM. This article presents the cultural considerations undertaken to successfully implement the study. The research procedures were accepted and approved by cultural liaisons and potential participants. The approved methodology involved a trial evaluating and comparing the effects of two, 16-week exercise regimens (i.e. aerobic training and resistance training) on glycosylated haemoglobin (HbA1c), related diabetes markers (i.e. insulin resistance, blood lipids, relevant cytokines and anthropometric and hemodynamic indices) and health-related quality of life. Future exercise-related research or implementation strategies in this cohort should focus on cultural awareness and techniques to enhance participation and compliance. Our approach to cultural consultation could be considered by researchers undertaking trials in this and other ethnic populations suffering an extreme burden of T2DM, including indigenous Australians and Americans. PMID:23024717

  17. A Student Affairs Odyssey.

    ERIC Educational Resources Information Center

    Sandeen, Arthur

    1993-01-01

    Considers the future of student affairs work in higher education. Begins in the year 2003 at meeting of International Association of Student Affairs and travels back in time through other annual meetings of the association. Compares this fictitious odyssey with Homer's "Odyssey" throughout the article. (NB)

  18. Caring letters for suicide prevention: implementation of a multi-site randomized clinical trial in the U.S. military and Veteran Affairs healthcare systems.

    PubMed

    Luxton, David D; Thomas, Elissa K; Chipps, Joan; Relova, Rona M; Brown, Daphne; McLay, Robert; Lee, Tina T; Nakama, Helenna; Smolenski, Derek J

    2014-03-01

    Caring letters is a suicide prevention intervention that entails the sending of brief messages that espouse caring concern to patients following discharge from treatment. First tested more than four decades ago, this intervention is one of the only interventions shown in a randomized controlled trial to reduce suicide mortality rates. Due to elevated suicide risk among patients following psychiatric hospitalization and the steady increase in suicide rates among the U.S. military personnel, it is imperative to test interventions that may help prevent suicide among high-risk military personnel and veterans. This paper describes the design, methods, study protocol, and regulatory implementation processes for a multi-site randomized controlled trial that aims to evaluate the effectiveness of a caring emails intervention for suicide prevention in the military and VA healthcare systems. The primary outcome is suicide mortality rates to be determined 24 months post-discharge from index hospital stay. Healthcare re-utilization rates will also be evaluated and comprehensive data will be collected regarding suicide risk factors. Recommendations for navigating the military and VA research regulatory processes and implementing a multi-site clinical trial at military and VA hospitals are discussed. PMID:24473106

  19. Barriers to Clinical Research Participation in a Diabetes Randomized Clinical Trial

    PubMed Central

    Yozwiak, John A; Bearman, Diane L; Strand, Trudy D; Strasburg, Katherine R

    2009-01-01

    Little is known about how barriers to research participation are perceived, affected by or interact with patient characteristics, or how they vary over the course of a clinical trial. Participants (285) in the Renin-Angiotensin System Study (RASS), a randomized clinical primary prevention study of diabetic nephropathy and retinopathy at 2 Canadiana dn 1 US university, rated potential barriers to research participation yearly for 5 years. Baseline barriers rated as most adversely affecting participation were: missing work; frequency of appointments and procedures; study length; number of appointments and procedures; access to study location; and physical discomfort associated with procedures. Inadequate social support, unstable job, and use of alcohol and drugs were cited relatively infrequently, suggesting that although they may be important, candidates for whom these might be issues likely self-selected out of the study. Gender and gender by age interactions were found for specific perceived barriers, such as work and child care, and baseline barriers correlated with adherence. Elucidating the natural history of barriers to research participation is a step toward identifying strategies for helping participants overcome them, and ultimately may enhance the conduct of research. PMID:19167143

  20. Systemic oxygen therapy versus oral enalapril for treatment of diabetic macular ischemia: a randomized controlled trial.

    PubMed

    Sharifipour, Farideh; Razzaghi, Mohammadreza; Ramezani, Alireza; Azarmina, Mohsen; Yaseri, Mehdi; Soheilian, Roham; Soheilian, Masoud

    2016-04-01

    The purpose of this study was to evaluate the structural and functional effects of systemic oxygen therapy and enalapril in patients with diabetic macular ischemia (DMI). This randomized clinical trial consisted of 105 eyes with DMI divided into three groups. Group I received systemic oxygen by face mask at a flow rate of 10 L/min; Group II received 5 mg enalapril daily; and Group III received placebo tablets for 3 months. Best-corrected visual acuity (BCVA), central macular thickness (CMT) measured by optical coherence tomography (OCT), extent of foveal avascular zone (FAZ) on fluorescein angiograms, and electroretinograms (ERG) were obtained at baseline and after 3 and 6 months. Overall, 102 patients completed the study. Baseline characteristics were not significantly different among groups. Significant improvement in BCVA and decrease in CMT and FAZ occurred at months 3 and 6 in oxygen group compared to deterioration in enalapril and control groups (All P values <0.001). ERG parameters were significantly better in oxygen group compared to enalapril group at months 3 and 6 and better than those in control group at month 3. Normobaric oxygen therapy for 3 months in DMI decreased CMT and FAZ and improved BCVA and ERG parameters. Enalapril did not show any favorable effect. PMID:26292645

  1. Recruitment of black women with type 2 diabetes into a self-management intervention trial.

    PubMed

    Newlin, Kelley; Melkus, Gail D'Eramo; Jefferson, Vanessa; Langerman, Susan; Womack, Julie; Chyun, Deborah

    2006-01-01

    The purpose of this study was to evaluate the relationship of recruitment methods to enrollment status in Black women with type 2 diabetes screened for entry into a randomized clinical trial (RCT). Using a cross-sectional study design with convenience sampling procedures, data were collected on recruitment methods to which the women responded (N=236). Results demonstrated that the RCT had a moderate overall recruitment rate of 46% and achieved only 84% of its projected accrual goal (N=109). Chi-square analysis demonstrated that enrollment outcomes varied significantly according to recruitment methods (P=.05). Recruitment methods such as community health fairs (77.8%), private practice referrals (75.0%), participant referrals (61.5%), community clinic referrals (44.6%), community advertising and marketing (40.9%), and chart review (40.4%) demonstrated variable enrollment yields. Results confirm previous findings that indicate that Black Americans may be successfully recruited into research studies at moderate rates when traditional recruitment methods are enhanced and integrated with more culturally sensitive methods. Lessons learned are considered. PMID:17061753

  2. The Resist Diabetes trial: Rationale, design, and methods of a hybrid efficacy/effectiveness intervention trial for resistance training maintenance to improve glucose homeostasis in older prediabetic adults

    PubMed Central

    Marinik, Elaina L.; Kelleher, Sarah; Savla, Jyoti; Winett, Richard A.; Davy, Brenda M.

    2014-01-01

    Advancing age is associated with reduced levels of physical activity, increased body weight and fat, decreased lean body mass, and a high prevalence of type 2 diabetes (T2D). Resistance training (RT) increases muscle strength and lean body mass, and reduces risk of T2D among older adults. The Resist Diabetes trial will determine if a social cognitive theory (SCT)-based intervention improves RT maintenance in older, prediabetic adults, using a hybrid efficacy/effectiveness approach. Sedentary, overweight/obese (BMI 25-39.9 kg/m2) adults aged 50-69 (N=170) with prediabetes (impaired fasting glucose and/or impaired glucose tolerance) completed a supervised 3-month RT (2x/wk) Initiation Phase and were then randomly assigned (n=159; 94% retention) to one of two 6-month maintenance conditions: SCT or Standard care. The SCT intervention consisted of faded contacts compared to Standard care. Participants continue RT at an approved, self-selected community facility during maintenance. A subsequent 6-month period involves no contact for both conditions. Assessments occur at baseline and months 3 (post-initiation), 9 (post-intervention), and 15 (six months after no contact). Primary outcomes are prediabetes indices (i.e., impaired fasting and 2-hour glucose concentration) and strength. Secondary measures include insulin sensitivity, beta-cell responsiveness, and disposition index (oral glucose and C-peptide minimal model); adherence; body composition; and SCT measures. Resist Diabetes is the first trial to examine the effectiveness of a high fidelity SCT-based intervention for maintaining RT in older adults with prediabetes to improve glucose homeostasis. Successful application of SCT constructs for RT maintenance may support translation of our RT program for diabetes prevention into community settings. PMID:24252311

  3. The resist diabetes trial: Rationale, design, and methods of a hybrid efficacy/effectiveness intervention trial for resistance training maintenance to improve glucose homeostasis in older prediabetic adults.

    PubMed

    Marinik, Elaina L; Kelleher, Sarah; Savla, Jyoti; Winett, Richard A; Davy, Brenda M

    2014-01-01

    Advancing age is associated with reduced levels of physical activity, increased body weight and fat, decreased lean body mass, and a high prevalence of type 2 diabetes (T2D). Resistance training (RT) increases muscle strength and lean body mass, and reduces risk of T2D among older adults. The Resist Diabetes trial will determine if a social cognitive theory (SCT)-based intervention improves RT maintenance in older, prediabetic adults, using a hybrid efficacy/effectiveness approach. Sedentary, overweight/obese (BMI: 25-39.9 kg/m(2)) adults aged 50-69 (N = 170) with prediabetes (impaired fasting glucose and/or impaired glucose tolerance) completed a supervised 3-month RT (2×/wk) initiation phase and were then randomly assigned (N = 159; 94% retention) to one of two 6-month maintenance conditions: SCT or standard care. The SCT intervention consisted of faded contacts compared to standard care. Participants continue RT at an approved, self-selected community facility during maintenance. A subsequent 6-month period involves no contact for both conditions. Assessments occur at baseline and months 3 (post-initiation), 9 (post-intervention), and 15 (six months after no contact). Primary outcomes are prediabetes indices (i.e., impaired fasting and 2-hour glucose concentration) and strength. Secondary measures include insulin sensitivity, beta-cell responsiveness, and disposition index (oral glucose and C-peptide minimal model); adherence; body composition; and SCT measures. Resist Diabetes is the first trial to examine the effectiveness of a high fidelity SCT-based intervention for maintaining RT in older adults with prediabetes to improve glucose homeostasis. Successful application of SCT constructs for RT maintenance may support translation of our RT program for diabetes prevention into community settings. PMID:24252311

  4. Glycation and Carboxymethyllysine Levels in Skin Collagen Predict the Risk of Future 10-Year Progression of Diabetic Retinopathy and Nephropathy in the Diabetes Control and Complications Trial and Epidemiology of Diabetes Interventions and Complications Participants With Type 1 Diabetes

    PubMed Central

    Genuth, Saul; Sun, Wanjie; Cleary, Patricia; Sell, David R.; Dahms, William; Malone, John; Sivitz, William; Monnier, Vincent M.

    2009-01-01

    Several mechanistic pathways linking hyperglycemia to diabetes complications, including glycation of proteins and formation of advanced glycation end products (AGEs), have been proposed. We investigated the hypothesis that skin collagen glycation and AGEs predict the risk of progression of microvascular disease. We measured glycation products in the skin collagen of 211 Diabetes Control and Complications Trial (DCCT) volunteers in 1992 who continued to be followed in the Epidemiology of Diabetes Interventions and Complications study for 10 years. We determined whether the earlier measurements of glycated collagen and AGE levels correlated with the risk of progression of retinopathy and nephropathy from the end of the DCCT to 10 years later. In multivariate analyses, the combination of furosine (glycated collagen) and carboxymethyllysine (CML) predicted the progression of retinopathy (χ2 = 59.4, P < 0.0001) and nephropathy (χ2 = 18.2, P = 0.0001), even after adjustment for mean HbA1c (A1C) (χ2 = 32.7, P < 0.0001 for retinopathy) and (χ2 = 12.8, P = 0.0016 for nephropathy). The predictive effect of A1C vanished after adjustment for furosine and CML (χ2 = 0.0002, P = 0.987 for retinopathy and χ2 = 0.0002, P = 0.964 for nephropathy). Furosine explained more of the variation in the 10-year progression of retinopathy and nephropathy than did CML. These results strengthen the role of glycation of proteins and AGE formation in the pathogenesis of retinopathy and nephropathy. Glycation and subsequent AGE formation may explain the risk of these complications associated with prior A1C and provide a rational basis for the phenomenon of “metabolic memory” in the pathogenesis of these diabetes complications. PMID:16249432

  5. HMG-coenzyme A reductase inhibition, type 2 diabetes, and bodyweight: evidence from genetic analysis and randomised trials

    PubMed Central

    Swerdlow, Daniel I; Preiss, David; Kuchenbaecker, Karoline B; Holmes, Michael V; Engmann, Jorgen E L; Shah, Tina; Sofat, Reecha; Stender, Stefan; Johnson, Paul C D; Scott, Robert A; Leusink, Maarten; Verweij, Niek; Sharp, Stephen J; Guo, Yiran; Giambartolomei, Claudia; Chung, Christina; Peasey, Anne; Amuzu, Antoinette; Li, KaWah; Palmen, Jutta; Howard, Philip; Cooper, Jackie A; Drenos, Fotios; Li, Yun R; Lowe, Gordon; Gallacher, John; Stewart, Marlene C W; Tzoulaki, Ioanna; Buxbaum, Sarah G; van der A, Daphne L; Forouhi, Nita G; Onland-Moret, N Charlotte; van der Schouw, Yvonne T; Schnabel, Renate B; Hubacek, Jaroslav A; Kubinova, Ruzena; Baceviciene, Migle; Tamosiunas, Abdonas; Pajak, Andrzej; Topor-Madry, Romanvan; Stepaniak, Urszula; Malyutina, Sofia; Baldassarre, Damiano; Sennblad, Bengt; Tremoli, Elena; de Faire, Ulf; Veglia, Fabrizio; Ford, Ian; Jukema, J Wouter; Westendorp, Rudi G J; de Borst, Gert Jan; de Jong, Pim A; Algra, Ale; Spiering, Wilko; der Zee, Anke H Maitland-van; Klungel, Olaf H; de Boer, Anthonius; Doevendans, Pieter A; Eaton, Charles B; Robinson, Jennifer G; Duggan, David; Kjekshus, John; Downs, John R; Gotto, Antonio M; Keech, Anthony C; Marchioli, Roberto; Tognoni, Gianni; Sever, Peter S; Poulter, Neil R; Waters, David D; Pedersen, Terje R; Amarenco, Pierre; Nakamura, Haruo; McMurray, John J V; Lewsey, James D; Chasman, Daniel I; Ridker, Paul M; Maggioni, Aldo P; Tavazzi, Luigi; Ray, Kausik K; Seshasai, Sreenivasa Rao Kondapally; Manson, JoAnn E; Price, Jackie F; Whincup, Peter H; Morris, Richard W; Lawlor, Debbie A; Smith, George Davey; Ben-Shlomo, Yoav; Schreiner, Pamela J; Fornage, Myriam; Siscovick, David S; Cushman, Mary; Kumari, Meena; Wareham, Nick J; Verschuren, W M Monique; Redline, Susan; Patel, Sanjay R; Whittaker, John C; Hamsten, Anders; Delaney, Joseph A; Dale, Caroline; Gaunt, Tom R; Wong, Andrew; Kuh, Diana; Hardy, Rebecca; Kathiresan, Sekar; Castillo, Berta A; van der Harst, Pim; Brunner, Eric J; Tybjaerg-Hansen, Anne; Marmot, Michael G; Krauss, Ronald M; Tsai, Michael; Coresh, Josef; Hoogeveen, Ronald C; Psaty, Bruce M; Lange, Leslie A; Hakonarson, Hakon; Dudbridge, Frank; Humphries, Steve E; Talmud, Philippa J; Kivimäki, Mika; Timpson, Nicholas J; Langenberg, Claudia; Asselbergs, Folkert W; Voevoda, Mikhail; Bobak, Martin; Pikhart, Hynek; Wilson, James G; Reiner, Alex P; Keating, Brendan J; Hingorani, Aroon D; Sattar, Naveed

    2015-01-01

    Summary Background Statins increase the risk of new-onset type 2 diabetes mellitus. We aimed to assess whether this increase in risk is a consequence of inhibition of 3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR), the intended drug target. Methods We used single nucleotide polymorphisms in the HMGCR gene, rs17238484 (for the main analysis) and rs12916 (for a subsidiary analysis) as proxies for HMGCR inhibition by statins. We examined associations of these variants with plasma lipid, glucose, and insulin concentrations; bodyweight; waist circumference; and prevalent and incident type 2 diabetes. Study-specific effect estimates per copy of each LDL-lowering allele were pooled by meta-analysis. These findings were compared with a meta-analysis of new-onset type 2 diabetes and bodyweight change data from randomised trials of statin drugs. The effects of statins in each randomised trial were assessed using meta-analysis. Findings Data were available for up to 223 463 individuals from 43 genetic studies. Each additional rs17238484-G allele was associated with a mean 0·06 mmol/L (95% CI 0·05–0·07) lower LDL cholesterol and higher body weight (0·30 kg, 0·18–0·43), waist circumference (0·32 cm, 0·16–0·47), plasma insulin concentration (1·62%, 0·53–2·72), and plasma glucose concentration (0·23%, 0·02–0·44). The rs12916 SNP had similar effects on LDL cholesterol, bodyweight, and waist circumference. The rs17238484-G allele seemed to be associated with higher risk of type 2 diabetes (odds ratio [OR] per allele 1·02, 95% CI 1·00–1·05); the rs12916-T allele association was consistent (1·06, 1·03–1·09). In 129 170 individuals in randomised trials, statins lowered LDL cholesterol by 0·92 mmol/L (95% CI 0·18–1·67) at 1-year of follow-up, increased bodyweight by 0·24 kg (95% CI 0·10–0·38 in all trials; 0·33 kg, 95% CI 0·24–0·42 in placebo or standard care controlled trials and −0·15 kg, 95% CI −0·39 to 0·08 in intensive

  6. Effect of aliskiren and valsartan combination versus aliskiren monotherapy on hemostatic biomarkers in hypertensive diabetics: Aliskiren and Valsartan Impact in Diabetics pilot trial.

    PubMed

    Serebruany, Victor L; Pokov, Alex N; Aradi, Daniel; Can, Mehmet; DiNicolantonio, James; Kipshidze, Nodar; Atar, Dan

    2014-01-01

    Valsartan is known to inhibit platelet activity in both in vitro and ex vivo clinical setting, whereas aliskiren in vitro modulates antithrombin-III in plasma. The authors tested how aliskiren and valsartan combination versus aliskiren monotherapy will affect hemostatic biomarkers in mild-to-moderate hypertensive diabetics in the frame of the Aliskiren and Valsartan Impact in Diabetics (AVID) trial. A total of 52 patients with type 2 diabetes and mild-to-moderate hypertension were equally randomized to aliskiren (150-300 mg/d) and valsartan (160 mg/d) versus aliskiren (150-300 mg/d) alone for 4 weeks. A total of 25 biomarkers were serially measured, of which 16 are related to platelet function, 6 to coagulation, and 3 to fibrinolysis. Aliskiren monotherapy has no significant impact on any of the assessed biomarkers. In contrast, valsartan on top of aliskiren provided significant inhibition of ADP-induced platelet aggregation (P=0.032), decreased shear-induced activation measured with PFA-100 analyzer (P=0.041), and diminished expression of GP IIb/IIIa activity (P=0.027) measured by PAC-1 antibody, GP Ib (CD42b, P=0.033), vitronectin receptor (CD51/61, P=0.046), P-selectin (CD62p, P=0.026), lysosome-associated membrane protein (CD107a, P=0.042), and CD40-ligand (CD154, P=0.048). In AVID trial, valsartan in combination with aliskiren mildly but significantly inhibited platelets, confirming previous observations. In contrast, aliskiren monotherapy does not enhance antithrombin activity, suggesting that previous data probably represent a laboratory artifact. Importantly, these randomized data were generated on top of low-dose daily aspirin, supporting extra benefit for combination use of angiotensin receptor blockers and renin inhibitors in high-risk diabetic population. PMID:23698186

  7. Prevention of gestational diabetes through lifestyle intervention: study design and methods of a Finnish randomized controlled multicenter trial (RADIEL)

    PubMed Central

    2014-01-01

    Background Maternal overweight, obesity and consequently the incidence of gestational diabetes are increasing rapidly worldwide. The objective of the study was to assess the efficacy and cost-effectiveness of a combined diet and physical activity intervention implemented before, during and after pregnancy in a primary health care setting for preventing gestational diabetes, later type 2 diabetes and other metabolic consequences. Methods RADIEL is a randomized controlled multi-center intervention trial in women at high risk for diabetes (a previous history of gestational diabetes or prepregnancy BMI ≥30 kg/m2). Participants planning pregnancy or in the first half of pregnancy were parallel-group randomized into an intervention arm which received lifestyle counseling and a control arm which received usual care given at their local antenatal clinics. All participants visited a study nurse every three months before and during pregnancy, and at 6 weeks, 6 and 12 months postpartum. Measurements and laboratory tests were performed on all participants with special focus on dietary and exercise habits and metabolic markers. Of the 728 women [mean age 32.5 years (SD 4.7); median parity 1 (range 0-9)] considered to be eligible for the study 235 were non-pregnant and 493 pregnant [mean gestational age 13 (range 6 to 18) weeks] at the time of enrollment. The proportion of nulliparous women was 29.8% (n = 217). Out of all participants, 79.6% of the non-pregnant and 40.4% of the pregnant women had previous gestational diabetes and 20.4% of the non-pregnant and 59.6% of the pregnant women were recruited because of a prepregnancy BMI ≥30 kg/m2. Mean BMI at first visit was 30.1 kg/m2 (SD 6.2) in the non-pregnant and 32.7 kg/m2 (SD 5.6) in the pregnant group. Discussion To our knowledge, this is the first randomized lifestyle intervention trial, which includes, besides the pregnancy period, both the prepregnancy and the postpartum period. This study design also

  8. Individualized electronic decision support and reminders to improve diabetes care in the community: COMPETE II randomized trial

    PubMed Central

    Holbrook, Anne; Thabane, Lehana; Keshavjee, Karim; Dolovich, Lisa; Bernstein, Bob; Chan, David; Troyan, Sue; Foster, Gary; Gerstein, Hertzel

    2009-01-01

    Background Diabetes mellitus is a complex disease with serious complications. Electronic decision support, providing information that is shared and discussed by both patient and physician, encourages timely interventions and may improve the management of this chronic disease. However, it has rarely been tested in community-based primary care. Methods In this pragmatic randomized trial, we randomly assigned adult primary care patients with type 2 diabetes to receive the intervention or usual care. The intervention involved shared access by the primary care provider and the patient to a Web-based, colour-coded diabetes tracker, which provided sequential monitoring values for 13 diabetes risk factors, their respective targets and brief, prioritized messages of advice. The primary outcome measure was a process composite score. Secondary outcomes included clinical composite scores, quality of life, continuity of care and usability. The outcome assessors were blinded to each patient’s intervention status. Results We recruited sequentially 46 primary care providers and then 511 of their patients (mean age 60.7 [standard deviation 12.5] years). Mean follow-up was 5.9 months. The process composite score was significantly better for patients in the intervention group than for control patients (difference 1.27, 95% confidence interval [CI] 0.79–1.75, p < 0.001); 61.7% (156/253) of patients in the intervention group, compared with 42.6% (110/258) of control patients, showed improvement (difference 19.1%, p < 0.001). The clinical composite score also had significantly more variables with improvement for the intervention group (0.59, 95% CI 0.09–1.10, p = 0.02), including significantly greater declines in blood pressure (−3.95 mm Hg systolic and −2.38 mm Hg diastolic) and glycated hemoglobin (−0.2%). Patients in the intervention group reported greater satisfaction with their diabetes care. Interpretation A shared electronic decision-support system to support the

  9. Cluster randomized trial in smoking cessation with intensive advice in diabetic patients in primary care. ITADI Study

    PubMed Central

    2010-01-01

    Background It is a priority to achieve smoking cessation in diabetic smokers, given that this is a group of patients with elevated cardiovascular risk. Furthermore, tobacco has a multiplying effect on micro and macro vascular complications. Smoking abstinence rates increase as the intensity of the intervention, length of the intervention and number and diversity of contacts with the healthcare professional during the intervention increases. However, there are few published studies about smoking cessation in diabetics in primary care, a level of healthcare that plays an essential role in these patients. Therefore, the aim of the present study is to evaluate the effectiveness of an intensive smoking cessation intervention in diabetic patients in primary care. Methods/Design Cluster randomized trial, controlled and multicentric. Randomization unit: Primary Care Team. Study population: 546 diabetic smokers older than 14 years of age whose disease is controlled by one of the primary care teams in the study. Outcome Measures: Continuous tobacco abstinence (a person who has not smoked for at least six months and with a CO level of less than 6 ppm measured by a cooximeter) , evolution in the Prochaska and DiClemente's Transtheoretical Model of Change, number of cigarettes/day, length of the visit. Point of assessment: one- year post- inclusion in the study. Intervention: Brief motivational interview for diabetic smokers at the pre-contemplation and contemplation stage, intensive motivational interview with pharmacotherapy for diabetic smokers in the preparation-action stage and reinforcing intevention in the maintenance stage. Statistical Analysis: A descriptive analysis of all variables will be done, as well as a multilevel logistic regression and a Poisson regression. All analyses will be done with an intention to treatment basis and will be fitted for potential confounding factors and variables of clinical importance. Statistical packages: SPSS15, STATA10 y HLM6

  10. Improving Diabetes Self-Management through Acceptance, Mindfulness, and Values: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Gregg, Jennifer A.; Callaghan, Glenn M.; Hayes, Steven C.; Glenn-Lawson, June L.

    2007-01-01

    Patients in a low-income community health center with Type 2 diabetes (N = 81) taking a one-day education workshop as part of their diabetes medical management were randomly assigned either to education alone or to a combination of education and acceptance and commitment therapy (ACT). Both groups were taught how to manage their diabetes, but…

  11. Recruitment of Asians and Pacific Islanders with Type 2 Diabetes into a Clinical Research Trial of Enhancing Diabetes Self-Management.

    PubMed

    Wong, Lorrie C; Ribeiro, Malia; Vasquez-Brooks, Mirella; Estrella, Dominic; Wang, Chen-Yen; Arakaki, Richard; Inouye, Jillian

    2015-01-01

    The objective of the study was to evaluate strategies and barriers to recruiting Asians and Pacific Islanders (API) with type 2 diabetes, into clinical trials. Descriptive statistics and content analysis were utilized to analyze reasons for non-participation. A "talk story" interview method was employed to recruit participants and uncover reasons for non-participation. A total of 1891 potential participants were identified and 340 declined participation. Eighty who declined were randomly selected to provide their reasons for non-participation. Socioeconomic issues faced by this population, such as earning wages to meet basic needs and care giving took precedence over altruistic participation in research. PMID:26817172

  12. Protein Diet Restriction Slows Chronic Kidney Disease Progression in Non-Diabetic and in Type 1 Diabetic Patients, but Not in Type 2 Diabetic Patients: A Meta-Analysis of Randomized Controlled Trials Using Glomerular Filtration Rate as a Surrogate

    PubMed Central

    Rughooputh, Mahesh Shumsher; Zeng, Rui; Yao, Ying

    2015-01-01

    Background/ Objective Studies, including various meta-analyses, on the effect of Protein Diet Restriction on Glomerular Filtration Rate (GFR) in Chronic Kidney Disease (CKD) have reported conflicting results. In this paper, we have provided an update on the evidence available on this topic. We have investigated the reasons why the effect has been inconsistent across studies. We have also compared the effect on GFR in various subgroups including type 1 diabetics, type 2 diabetics and non-diabetics. Method We searched for Randomized Controlled Trials on this intervention from MEDLINE, EMBASE, and other information sources. The PRISMA guidelines, as well as recommended meta-analysis practices were followed in the selection process, analysis and reporting of our findings. The effect estimate used was the change in mean GFR. Heterogeneity across the considered studies was explored using both subgroup analyses and meta-regression. Quality assessment was done using the Cochrane risk of bias tool and sensitivity analyses. Results 15 randomized controlled trials, including 1965 subjects, were analyzed. The pooled effect size, as assessed using random-effects model, for all the 15 studies was -0.95 ml/min/1.73m2/year (95% CI: -1.79, -0.11), with a significant p value of 0.03. The combined effect estimate for the non-diabetic and type 1 diabetic studies was -1.50 ml/min/1.73m2/year (95% CI: -2.73, -0.26) with p value of 0.02. The effect estimate for the type 2 diabetic group was -0.17 ml/min/1.73m2/year (95% CI: -1.88, 1.55) with p value of 0.85. There was significant heterogeneity across the included studies (I2 = 74%, p value for Q < 0.0001), explained by major variations in the percentage of type 2 diabetic subjects, the number of subjects and overall compliance level to diet prescribed. Conclusion Our findings suggest that protein diet restriction slows chronic renal disease progression in non-diabetic and in type 1 diabetic patients, but not in type 2 diabetic patients

  13. Statins but Not Aspirin Reduce Thrombotic Risk Assessed by Thrombin Generation in Diabetic Patients without Cardiovascular Events: The RATIONAL Trial

    PubMed Central

    Macchia, Alejandro; Laffaye, Nicolás; Comignani, Pablo D.; Cornejo Pucci, Elena; Igarzabal, Cecilia; Scazziota, Alejandra S.; Herrera, Lourdes; Mariani, Javier A.; Bragagnolo, Julio C.; Catalano, Hugo; Tognoni, Gianni; Nicolucci, Antonio

    2012-01-01

    Background The systematic use of aspirin and statins in patients with diabetes and no previous cardiovascular events is controversial. We sought to assess the effects of aspirin and statins on the thrombotic risk assessed by thrombin generation (TG) among patients with type II diabetes mellitus and no previous cardiovascular events. Methodology/Principal Findings Prospective, randomized, open, blinded to events evaluation, controlled, 2×2 factorial clinical trial including 30 patients randomly allocated to aspirin 100 mg/d, atorvastatin 40 mg/d, both or none. Outcome measurements included changes in TG levels after treatment (8 to 10 weeks), assessed by a calibrated automated thrombogram. At baseline all groups had similar clinical and biochemical profiles, including TG levels. There was no interaction between aspirin and atorvastatin. Atorvastatin significantly reduced TG measured as peak TG with saline (85.09±55.34 nmol vs 153.26±75.55 nmol for atorvastatin and control groups, respectively; p = 0.018). On the other hand, aspirin had no effect on TG (121.51±81.83 nmol vs 116.85±67.66 nmol, for aspirin and control groups, respectively; p = 0.716). The effects of treatments on measurements of TG using other agonists were consistent. Conclusions/Significance While waiting for data from ongoing large clinical randomized trials to definitively outline the role of aspirin in primary prevention, our study shows that among diabetic patients without previous vascular events, statins but not aspirin reduce thrombotic risk assessed by TG. Trial Registration ClinicalTrials.gov NCT00793754 PMID:22470429

  14. Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial

    PubMed Central

    Thalange, N; Bereket, A; Larsen, J; Hiort, L C; Peterkova, V

    2013-01-01

    Aims This 52-week, randomized, multinational, open-label, parallel-group, non-inferiority trial investigated the efficacy and safety of basal–bolus treatment with insulin detemir vs. NPH (neutral protamine Hagedorn) insulin, in combination with insulin aspart, in subjects aged 2–16 years with Type 1 diabetes mellitus. Methods Of the 347 randomized and exposed subjects, 177 received insulin detemir and 170 NPH insulin, both administered once or twice daily in combination with mealtime insulin aspart. Glycaemic measurements and weight were followed over 52 weeks. Results After 52 weeks, insulin detemir was shown to be non-inferior to NPH insulin with regard to HbA1c [mean difference insulin detemir–NPH: 1.30 mmol/mol, 95% CI –1.32 to 3.92 (0.12%, 95% CI –0.12 to 0.36) in the full analysis set and 1.41 mmol/mol, 95% CI –1.26 to 4.08 (0.13%, 95% CI –0.12 to 0.37) in the per protocol analysis set]. Hypoglycaemic events per subject-year of exposure of 24-h and nocturnal hypoglycaemia were significantly lower with insulin detemir than with NPH insulin (rate ratio 0.76, 95% CI 0.60–0.97, P = 0.028 and 0.62, 95% CI 0.47–0.84, P = 0.002, respectively). Weight standard deviation (sd) scores (body weight standardized by age and gender) decreased with insulin detemir, but increased slightly with NPH insulin (change: –0.12 vs. 0.04, P < 0.001). At end of the trial, median insulin doses were similar in both treatment groups. Conclusions Insulin detemir was non-inferior to NPH insulin after 52 weeks' treatment of children and adolescents aged 2–16 years, and was associated with a significantly lower risk of hypoglycaemia, together with significantly lower weight sd score when compared with NPH insulin. PMID:23094597

  15. A Phase 2 Randomized Clinical Trial of Intravitreal Bevacizumab for Diabetic Macular Edema

    PubMed Central

    2008-01-01

    Objective To provide data on the short-term effect of intravitreal bevacizumab for diabetic macular edema (DME). Design Randomized phase 2 clinical trial. Participants 121 eyes of 121 subjects (109 eligible for analysis) with DME and Snellen acuity equivalent ranging from 20/32-20/320. Interventions Random assignment to one of five groups: focal photocoagulation at baseline (N=19, Group A), intravitreal injection of 1.25mg bevacizumab at baseline and 6 weeks (N=22, Group B), intravitreal injection of 2.5mg bevacizumab at baseline and 6 weeks (N=24, Group C), intravitreal injection of 1.25mg bevacizumab at baseline and sham injection at 6 weeks (N=22, Group D), or intravitreal injection of 1.25mg bevacizumab at baseline and 6 weeks with photocoagulation at 3 weeks (N=22, Group E). Main Outcome Measures Central subfield thickness (CST) on optical coherence tomography and best-corrected visual acuity (VA) were measured at baseline and after 3, 6, 9, 12, 18, and 24 weeks. Results At baseline, median CST was 411 microns and median Snellen VA equivalent was 20/50. Compared with Group A, Groups B and C had a greater reduction in CST at 3 weeks and about one line better median visual acuity over 12 weeks. There were no meaningful differences between Groups B and C in CST reduction or VA improvement. A CST reduction >11% (the reliability limit) was present at 3 weeks in 36/84 (43%) bevacizumab-treated eyes and in 5/18 (28%) eyes treated with laser alone, and at 6 weeks in 31/84 (37%) and 9/18 (50%) eyes, respectively. Combining focal photocoagulation with bevacizumab resulted in no apparent short-term benefit or adverse outcomes. Endophthalmitis developed in one eye. The following events occurred during the first 24 weeks in subjects treated with bevacizumab without attributing cause to the drug: myocardial infarction (N=2), congestive heart failure (N=1), elevated blood pressure (N=3), and worsened renal function (N=3). Conclusion These results demonstrate that

  16. Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program

    PubMed Central

    2013-01-01

    Background India currently has more than 60 million people with Type 2 Diabetes Mellitus (T2DM) and this is predicted to increase by nearly two-thirds by 2030. While management of those with T2DM is important, preventing or delaying the onset of the disease, especially in those individuals at ‘high risk’ of developing T2DM, is urgently needed, particularly in resource-constrained settings. This paper describes the protocol for a cluster randomised controlled trial of a peer-led lifestyle intervention program to prevent diabetes in Kerala, India. Methods/design A total of 60 polling booths are randomised to the intervention arm or control arm in rural Kerala, India. Data collection is conducted in two steps. Step 1 (Home screening): Participants aged 30–60 years are administered a screening questionnaire. Those having no history of T2DM and other chronic illnesses with an Indian Diabetes Risk Score value of ≥60 are invited to attend a mobile clinic (Step 2). At the mobile clinic, participants complete questionnaires, undergo physical measurements, and provide blood samples for biochemical analysis. Participants identified with T2DM at Step 2 are excluded from further study participation. Participants in the control arm are provided with a health education booklet containing information on symptoms, complications, and risk factors of T2DM with the recommended levels for primary prevention. Participants in the intervention arm receive: (1) eleven peer-led small group sessions to motivate, guide and support in planning, initiation and maintenance of lifestyle changes; (2) two diabetes prevention education sessions led by experts to raise awareness on T2DM risk factors, prevention and management; (3) a participant handbook containing information primarily on peer support and its role in assisting with lifestyle modification; (4) a participant workbook to guide self-monitoring of lifestyle behaviours, goal setting and goal review; (5) the health education

  17. Diabetes

    MedlinePlus

    ... glucose or pre-diabetes. These levels are risk factors for type 2 diabetes. Hemoglobin A1c (A1C) test: Normal is less than 5.7%; prediabetes is 5.7 to 6.4%; and diabetes is 6.5% or higher. Oral ...

  18. Effect of an Exercise Intervention on Gestational Diabetes Mellitus: A Randomized Controlled Trial

    PubMed Central

    Nobles, Carrie; Marcus, Bess H.; Stanek, Edward J.; Braun, Barry; Whitcomb, Brian W.; Solomon, Caren G.; Manson, JoAnn E.; Markenson, Glenn; Chasan-Taber, Lisa

    2015-01-01

    Objective To examine the effect of an individually-tailored, motivationally-matched prenatal exercise intervention on gestational diabetes mellitus (GDM) and other measures of glucose intolerance among ethnically diverse prenatal care patients at increased risk for GDM. Methods The Behaviors Affecting Baby and You Study randomized eligible women at a mean (SD) of 18.2 (4.1) weeks gestation to a 12-week individually tailored, motivationally matched exercise intervention or a comparison health and wellness intervention. The goal of the exercise intervention was to achieve the American College of Obstetricians and Gynecologists guidelines for physical activity during pregnancy. Diagnosis of GDM, impaired glucose tolerance (IGT), abnormal glucose screen, and screening glucose values (mg/dL) were abstracted from medical records. A sample size of 352 women (176 per group) was planned to have 80% power to detect reductions in risk of 35% or larger. Results From July, 2007 to December, 2012, a total of 251 (86.5%) women completed the intervention; n=124 and 127 in the exercise and comparison interventions, respectively. Based on an intention-to-treat analysis, no statistically significant differences between the intervention groups were observed; the relative odds of GDM in the exercise group was 0.61 (95% Confidence Interval [CI] 0.28–1.32) as compared to the health and wellness comparison group. Odds ratios for IGT and abnormal glucose screen were 0.68 (95% CI 0.35–1.34) and 0.86 (95% CI 0.51–1.47), respectively. The intervention had no effect on birth outcomes. Conclusion In this randomized trial among ethnically diverse pregnant women at increased risk for GDM, we found that a prenatal exercise intervention implemented in the second trimester did not result in a statistically significant reduction in relative odds for GDM, IGT, or abnormal glucose screen. PMID:25932848

  19. Acceleration of the loss of the first-phase insulin response during the progression to type 1 diabetes in diabetes prevention trial-type 1 participants.

    PubMed

    Sosenko, Jay M; Skyler, Jay S; Beam, Craig A; Krischer, Jeffrey P; Greenbaum, Carla J; Mahon, Jeffrey; Rafkin, Lisa E; Matheson, Della; Herold, Kevan C; Palmer, Jerry P

    2013-12-01

    We studied the change in the first-phase insulin response (FPIR) during the progression to type 1 diabetes (T1D). Seventy-four oral insulin trial progressors to T1D from the Diabetes Prevention Trial-Type 1 with at least one FPIR measurement after baseline and before diagnosis were studied. The FPIR was examined longitudinally in 26 progressors who had FPIR measurements during each of the 3 years before diagnosis. The association between the change from the baseline FPIR to the last FPIR and time to diagnosis was studied in the remainder (n = 48). The 74 progressors had lower baseline FPIR values than nonprogressors (n = 270), with adjustments made for age and BMI. In the longitudinal analysis of the 26 progressors, there was a greater decline in the FPIR from 1.5 to 0.5 years before diagnosis than from 2.5 to 1.5 years before diagnosis. This accelerated decline was also evident in a regression analysis of the 48 remaining progressors in whom the rate of decline became more marked with the approaching diagnosis. The patterns of decline were similar between the longitudinal and regression analyses. There is an acceleration of decline in the FPIR during the progression to T1D, which becomes especially marked between 1.5 and 0.5 years before diagnosis. PMID:23863814

  20. Public affairs plan

    SciTech Connect

    1995-09-01

    The purpose of the Uranium Mill Tailings Remedial Action (UMTRA) Project Public Affairs Plan is to establish goals for the fiscal year (FY) 1996 UMTRA Project public affairs program and to identify specific activities to be conducted during the year. It describes the roles of various agencies involved in the public affairs program and defines the functions of the UMTRA Project Technical Assistance Contractor (TAC) Public Affairs Department. It replaces the FY 1995 Public Affairs Plan (DOE/AL/62350-154). The plan also describes the US Department of Energy`s (DOE) plans to keep stakeholders and other members of the public informed about UMTRA Project policies, plans, and activities, and provide opportunities for stakeholders and interested segments of the public to participate in UMTRA Project decision-making processes. The plan applies to the UMTRA Project Team; the DOE Grand Junction Projects Office (GJPO); the DOE Albuquerque Operations Office, Office of Public Affairs (OPA); the TAC; the UMTRA Project Remedial Action Contractor (RAC); and other cooperating agencies.

  1. Expanded role of the dietitian in the Diabetes Control and Complications Trial: implications for clinical practice. The DCCT Research Group.

    PubMed

    Delahanty, L; Simkins, S W; Camelon, K

    1993-07-01

    Initially, the dietitians' role in the Diabetes Control and Complications Trial (DCCT) was specifically defined to include evaluation of potential study volunteers, collection of dietary histories, provision of nutrition education, and participation in team management meetings. As the study progressed, recognition of the importance of adherence to diet in achieving hemoglobin A1c goals and the occurrence of undesirable weight gain in patients assigned randomly to intensive therapy provided an opportunity for dietitians to use their skills intensively and broadly. The need for dietary adherence made DCCT teams aware that dietitians needed to become more active in recruiting and selecting study volunteers and in implementing and evaluating all aspects of intensive diabetes treatment. Increased involvement in these activities allowed dietitians to develop relationships with research patients that were necessary to negotiate treatment goals and improve insights into dietary issues affecting care. Recognition of the importance of dietitians to the DCCT and the empowering nature of the annual meeting of DCCT dietitians fostered continued expansion of the dietitians' role in the clinical centers and in studywide activities such as promotion of dietary adherence, ancillary studies, and publications. Dietitians participating in clinical trials are encouraged to develop their communication and counseling skills, seek out alliances with other team members, and explore opportunities for ancillary research. Such efforts will help to perpetuate this expanded model of the dietitians' role in clinical trials. PMID:8320401

  2. Consent for Genetics Studies Among Clinical Trial Participants: Findings from Action for Health in Diabetes (Look AHEAD)

    PubMed Central

    Espeland, Mark A.; Dotson, Kathy; Jaramillo, Sarah A.; Kahn, Steven E.; Harrison, Barbara; Montez, Maria; Foreyt, John P.; Montgomery, Brenda; Knowler, William C.

    2008-01-01

    Background Increasingly, genetic specimens are collected to expand the value of clinical trials through study of genetic effects on disease incidence, progression, or response to interventions. Purpose and methods We describe the experience obtaining IRB-approved DNA consent forms across the 19 institutions in the Action for Health in Diabetes (Look AHEAD), a clinical trial examining the effect of a lifestyle intervention for weight loss on the risk of serious cardiovascular events among individuals with type 2 diabetes. We document the rates participants provided consent for DNA research, identify participant characteristics associated with consent, and discuss implications for genetics research. Results IRB approval to participate was obtained from 17 of 19 institutions. The overall rate of consent was 89.6% among the 15 institutions that had completed consenting at the time of our analysis, which was higher than reported for other types of cohort studies. Consent rates were associated with factors expected to be associated with weight loss and cardiovascular disease and to affect the distribution of candidate genes. Non-consent occurred more frequently among participants grouped as African-American, Hispanic, female, more highly educated, or not dyslipidemic. Limitations The generalizabilty of results is limited by the inclusion/exclusion criteria of the trial. Conclusions Barriers to obtaining consent to participate in genetic studies may differ from other recruitment settings. Because of the potentially complex associations between personal characteristics related to adherence, outcomes, and gene distributions, differential rates of consent may introduce biases in estimates of genetic relationships. PMID:17060218

  3. Microbiological effects of periodontal therapy plus azithromycin in patients with diabetes: results from a randomized clinical trial.

    PubMed

    Hincapié, Juan P; Castrillón, Cesar A; Yepes, Fanny L; Roldan, Natalia; Becerra, María A; Moreno, Sandra M; Consuegra, Jessika; Contreras, Adolfo; Botero, Javier E

    2014-01-01

    Current evidence suggests that periodontal infection may aggravate diabetes control. The aim of this study was to determine the changes in the frequency with which Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetemcomitans were detected in patients with diabetes with the use of non-surgical therapy plus azithromycin in a randomized clinical trial. One hundred and five (105) patients with diabetes and chronic periodontitis were randomly assigned to three treatment groups: subgingival mechanical therapy with azithromycin, subgingival mechanical therapy with placebo and supragingival prophylaxis with azithromycin. Complete periodontal clinical examinations and detection of periodontal pathogens using polymerase chain reaction were carried out at baseline, 3, 6 and 9 months after periodontal therapy. The frequency with which Porphyromonas gingivalis, Treponemadenticola and Aggregatibacter actinomycetemcomitans were detected decreased at 3 months in all groups. Tannerella forsythia increased after3 months in all groups. All organisms had similar frequencies at 9 months in all groups. Subgingival mechanical therapy with adjunctive azithromycin had no additional effect on the frequency with which the periodontal pathogens investigated were detected in patients with diabetes. PMID:25523961

  4. Reduction of atherogenic risk in patients with type 2 diabetes by curcuminoid extract: a randomized controlled trial.

    PubMed

    Chuengsamarn, Somlak; Rattanamongkolgul, Suthee; Phonrat, Benjaluck; Tungtrongchitr, Rungsunn; Jirawatnotai, Siwanon

    2014-02-01

    Curcumin is a phytocompound found in the root of turmeric, a common herbal ingredient in many Asian cuisines. The compound contains anti-inflammatory activity, which is mediated through an up-regulation of adiponectin and reduction of leptin. Consumption of curcumin was shown to prevent some deteriorative conditions caused by inflammation, such as ulcerative colitis, rheumatoid arthritis and esophagitis, and so on. Inflammation-associated cardiovascular conditions such as atherosclerosis are common in diabetes patients. The anti-inflammation effect of curcumin might be beneficial to prevent such condition in these patients. We aim to evaluate an antiatherosclerosis effect of curcumin in diabetes patients. Effects of curcumin on risk factors for atherosclerosis were investigated in a 6-month randomized, double-blinded and placebo-controlled clinical trial that included subjects diagnosed with type 2 diabetes. An atherosclerosis parameter, the pulse wave velocity, and other metabolic parameters in patients treated with placebo and curcumin were compared. Our results showed that curcumin intervention significantly reduced pulse wave velocity, increased level of serum adiponectin and decreased level of leptin. These results are associated with reduced levels of homeostasis model assessment-insulin resistance, triglyceride, uric acid, visceral fat and total body fat. In summary, a 6-month curcumin intervention in type 2 diabetic population lowered the atherogenic risks. In addition, the extract helped to improve relevant metabolic profiles in this high-risk population. PMID:24445038

  5. The Effect of Intensive Glycemic Treatment on Coronary Artery Calcification in Type 1 Diabetic Participants of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study

    PubMed Central

    Cleary, Patricia A.; Orchard, Trevor J.; Genuth, Saul; Wong, Nathan D.; Detrano, Robert; Backlund, Jye-Yu C.; Zinman, Bernard; Jacobson, Alan; Sun, Wanjie; Lachin, John M.; Nathan, David M.

    2008-01-01

    The Epidemiology of Diabetes Interventions and Complications (EDIC) study, an observational follow-up of the Diabetes Control and Complications Trial (DCCT) type 1 diabetes cohort, measured coronary artery calcification (CAC), an index of atherosclerosis, with computed tomography (CT) in 1,205 EDIC patients at ~7–9 years after the end of the DCCT. We examined the influence of the 6.5 years of prior conventional versus intensive diabetes treatment during the DCCT, as well as the effects of cardiovascular disease risk factors, on CAC. The prevalences of CAC >0 and >200 Agatston units were 31.0 and 8.5%, respectively. Compared with the conventional treatment group, the intensive group had significantly lower geometric mean CAC scores and a lower prevalence of CAC >0 in the primary retinopathy prevention cohort, but not in the secondary intervention cohort, and a lower prevalence of CAC >200 in the combined cohorts. Waist-to-hip ratio, smoking, hypertension, and hypercholesterolemia, before or at the time of CT, were significantly associated with CAC in univariate and multivariate analyses. CAC was associated with mean HbA1c (A1C) levels before enrollment, during the DCCT, and during the EDIC study. Prior intensive diabetes treatment during the DCCT was associated with less atherosclerosis, largely because of reduced levels of A1C during the DCCT. PMID:17130504

  6. DEPRESSION AND DIABETES AMONG LOW-INCOME HISPANICS: DESIGN ELEMENTS OF A SOCIO-CULTURALLY ADAPTED COLLABORATIVE CARE MODEL RANDOMIZED CONTROLLED TRIAL*

    PubMed Central

    ELL, KATHLEEN; KATON, WAYNE; CABASSA, LEOPOLDO J.; XIE, BIN; LEE, PEY-JIUAN; KAPETANOVIC, SUAD; GUTERMAN, JEFFRY

    2012-01-01

    Objective This article describes design elements of the Multifaceted Depression and Diabetes Program (MDDP) randomized clinical trial. The MDDP trial hypothesizes that a socioculturally adapted collaborative care depression management intervention will reduce depressive symptoms and improve patient adherence to diabetes self-care regimens, glycemic control, and quality-of-life. In addition, baseline data of 387 low-income, 96% Hispanic, enrolled patients with major depression and diabetes are examined to identify study population characteristics consistent with trial design adaptations. Methods The PHQ-9 depression scale was used to identify patients meeting criteria for major depressive disorder (1 cardinal depression symptom + a PHQ-9 score of ≥ 10) from two community safety net clinics. Design elements included sociocultural adaptations in recruitment and efforts to reduce attrition and collaborative depression care management. Results Of 1,803 diabetes patients screened, 30.2% met criteria for major depressive disorder. Of 387 patients enrolled in the clinical trial, 98% had Type 2 diabetes, and 83% had glycated hemoglobin (HbA1c) levels ≥ 7%. Study recruitment rates and baseline data analyses identified socioeconomic and clinical factors that support trial design and intervention adaptations. Depression severity was significantly associated with diabetes complications, medical comorbidity, greater anxiety, dysthymia, financial worries, social stress, and poorer quality-of-life. Conclusion Low-income Hispanic patients with diabetes experience high prevalence of depressive disorder and depression severity is associated with socioeconomic stressors and clinical severity. Improving depression care management among Hispanic patients in public sector clinics should include intervention components that address self-care of diabetes and socioeconomic stressors. PMID:19860071

  7. Recruiting South Asians to a lifestyle intervention trial: experiences and lessons from PODOSA (Prevention of Diabetes & Obesity in South Asians)

    PubMed Central

    2011-01-01

    Background Despite the growing emphasis on the inclusion of ethnic minority patients in research, there is little published on the recruitment of these populations especially to randomised, community based, lifestyle intervention trials in the UK. Methods We share our experience of recruitment to screening in the PODOSA (Prevention of Diabetes and Obesity in South Asians) trial, which screened 1319 recruits (target 1800) for trial eligibility. A multi-pronged recruitment approach was used. Enrolment via the National Health Service included direct referrals from health care professionals and written invitations via general practices. Recruitment within the community was carried out by both the research team and through our partnerships with local South Asian groups and organisations. Participants were encouraged to refer friends and family throughout the recruitment period. Results Health care professionals referred only 55 potential participants. The response to written invitations via general practitioners was 5.2%, lower than reported in other general populations. Community orientated, personal approaches for recruitment were comparatively effective yielding 1728 referrals (82%) to the screening stage. Conclusions The PODOSA experience shows that a community orientated, personal approach for recruiting South Asian ethnic minority populations can be successful in a trial setting. We recommend that consideration is given to cover recruitment costs associated with community engagement and other personalised approaches. Researchers should consider prioritising approaches that minimise interference with professionals' work and, particularly in the current economic climate, keep costs to a minimum. The lessons learned in PODOSA should contribute to future community based trials in South Asians. Trial Registration Current Controlled Trials ISRCTN25729565 PMID:21978409

  8. Japan Diabetes Outcome Intervention Trial-1(J-DOIT1), a nationwide cluster randomized trial of type 2 diabetes prevention by telephone-delivered lifestyle support for high-risk subjects detected at health checkups: rationale, design, and recruitment

    PubMed Central

    2013-01-01

    Background Lifestyle modifications are considered the most effective means of delaying or preventing the development of type 2 diabetes (T2DM). To contain the growing population of T2DM, it is critical to clarify effective and efficient settings for intervention and modalities for intervention delivery with a wide population reach. The Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1) is a cluster randomized controlled trial to test whether goal-focused lifestyle coaching delivered by telephone can prevent the development of T2DM in high-risk individuals in a real-world setting. This paper describes the study design and recruitment of the study subjects. Methods For the recruitment of study subjects and their follow-up annually over 3 years, we employed health checkups conducted annually at communities and worksites. Health care divisions recruited from communities and companies across Japan formed groups as a cluster randomization unit. Candidates for the study, aged 20-65 years with fasting plasma glucose (FPG) of 5.6-6.9 mmol/l, were recruited from each group using health checkups results in 2006. Goal-focused lifestyle support is delivered by healthcare providers via telephone over a one-year period. Study subjects will be followed-up for three years by annual health checkups. Primary outcome is the development of diabetes defined as FPG≥7.0 mmol/l on annual health checkup or based on self-report, which is confirmed by referring to medical cards. Results Forty-three groups (clusters), formed from 17 health care divisions, were randomly assigned to an intervention arm (22 groups) or control arm (21 clusters) between March 2007 and February 2008. A total of 2840 participants, 1336 from the intervention and 1504 from the control arm, were recruited. Consent rate was about 20%, with no difference between the intervention and control arms. There were no differences in cluster size and characteristics of cluster between the groups. There were no differences in

  9. The Association of Genetic Markers for Type 2 Diabetes with Prediabetic Status - Cross-Sectional Data of a Diabetes Prevention Trial

    PubMed Central

    Zyriax, Birgit-Christiane; Salazar, Ramona; Hoeppner, Wolfgang; Vettorazzi, Eik; Herder, Christian; Windler, Eberhard

    2013-01-01

    Objective To investigate the association of risk alleles for type 2 diabetes with prediabetes accounting for age, anthropometry, inflammatory markers and lifestyle habits. Design Cross-sectional study of 129 men and 157 women of medium-sized companies in northern Germany in the Delay of Impaired Glucose Tolerance by a Healthy Lifestyle Trial (DELIGHT). Methods Besides established risk factors, 41 single nucleotide polymorphisms (SNPs) that have previously been found to be associated with type 2 diabetes were analyzed. As a nonparametric test a random forest approach was used that allows processing of a large number of predictors. Variables with the highest impact were entered into a multivariate logistic regression model to estimate their association with prediabetes. Results Individuals with prediabetes were characterized by a slightly, but significantly higher number of type 2 diabetes risk alleles (42.5±4.1 vs. 41.3±4.1, p = 0.013). After adjustment for age and waist circumference 6 SNPs with the highest impact in the random forest analysis were associated with risk for prediabetes in a logistic regression model. At least 5 of these SNPs were positively related to prediabetic status (odds ratio for prediabetes 1.57 per allele (Cl 1.21–2.10, p = 0.001)). Conclusions This explorative analysis of data of DELIGHT demonstrates that at least 6 out of 41 genetic variants characteristic of individuals with type 2 diabetes may also be associated with prediabetes. Accumulation of these risk alleles may markedly increase the risk for prediabetes. However, prospective studies are required to corroborate these findings and to demonstrate the predictive value of these genetic variants for the risk to develop prediabetes. PMID:24098730

  10. Baseline Characteristics of Patients with Diabetes and Coronary Artery Disease Enrolled in the BARI 2D Trial

    PubMed Central

    Brooks, Maria Mori; Barsness, Gregory; Chaitman, Bernard; Chung, Sheng-Chia; Faxon, David; Feit, Frederick; Frye, Robert; Genuth, Saul; Green, Jennifer; Hlatky, Mark; Kelsey, Sheryl; Kennedy, Frank; Krone, Ronald; Nesto, Richard; Orchard, Trevor; O'Rourke, Robert; Rihal, Charanjit; Tardif, Jean-Claude

    2009-01-01

    Background The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) was undertaken to determine whether early revascularization intervention is superior to deferred intervention in the presence of aggressive medical therapy and whether antidiabetes regimens targeting insulin sensitivity are more or less effective than regimens targeting insulin provision in reducing cardiovascular events among patients with type 2 diabetes mellitus and stable coronary artery disease (CAD). Methods BARI 2D is an NIH-sponsored randomized clinical trial with a 2×2 factorial design. Between 2001 and 2005, 49 clinical sites in North America, South America and Europe randomized 2,368 patients. At baseline, the trial collected data on clinical history, symptoms and medications along with centralized evaluations of angiograms, electrocardiograms, and blood and urine specimens. Results The majority of BARI 2D patients were referred from the cardiac catheterization laboratory (54%) or cardiology clinic (27%). Of the randomized participants, 30% were women, 34% were minorities, 61% had angina, and 67% had multi-region CAD. Moreover, 29% had been treated with insulin, 58% had HbA1c > 7.0%, 41% LDL cholesterol ≥ 100 mg/dl, 52% blood pressure > 130/80 mmHg, and 56% BMI ≥ 30 kg/m2. Conclusions Baseline characteristics in BARI 2D are well-balanced between the randomized treatment groups, and the clinical profile of the study cohort is representative of the target population. As a result, the BARI 2D clinical trial is in an excellent position to evaluate alternative treatment approaches for diabetes and CAD. PMID:18760137

  11. Cost effectiveness of group follow-up after structured education for type 1 diabetes: a cluster randomised controlled trial

    PubMed Central

    2014-01-01

    Background This study examines the cost effectiveness of group follow-up after participation in the Dose Adjustment for Normal Eating (DAFNE) structured education programme for type 1 diabetes. Methods Economic evaluation conducted alongside a cluster randomised controlled trial involving 437 adults with type 1 diabetes in Ireland. Group follow-up involved two group education ‘booster’ sessions post-DAFNE. Individual follow-up involved two standard one-to-one hospital clinic visits. Incremental costs, quality-adjusted life years (QALYs) gained and cost effectiveness were estimated at 18 months. Uncertainty was explored using sensitivity analysis and by estimating cost effectiveness acceptability curves. Results Group follow-up was associated with a mean reduction in QALYs gained of 0.04 per patient (P value, 0.052; 95% CI, −0.08 to 0.01, intra-class correlation (ICC), 0.033) and a mean reduction in total healthcare costs of €772 (P value, 0.020; 95% CI, −1,415 to −128: ICC, 0.016) per patient. At alternative threshold values of €5,000, €15,000, €25,000, €35,000, and €45,000, the probability of group follow-up being cost effective was estimated to be 1.000, 0.762, 0.204, 0.078, and 0.033 respectively. Conclusions The results do not support implementation of group follow-up as the sole means of follow-up post-DAFNE. Given the reported cost savings, future studies should explore the cost effectiveness of alternative models of group care for diabetes. Trial registration Current Controlled Trials ISRCTN79759174 (assigned: 9 February 2007). PMID:24927851

  12. Amlodipine versus angiotensin II receptor blocker; control of blood pressure evaluation trial in diabetics (ADVANCED-J)

    PubMed Central

    Kawamori, Ryuzo; Daida, Hiroyuki; Tanaka, Yasushi; Miyauchi, Katsumi; Kitagawa, Akira; Hayashi, Dobun; Kishimoto, Junji; Ikeda, Shunya; Imai, Yutaka; Yamazaki, Tsutomu

    2006-01-01

    Background The coexistence of type 2 diabetes mellitus and hypertension increases the risk of cardiovascular diseases. The U.K. Prospective Diabetes Study has shown that blood pressure control as well as blood glucose control is efficient for prevention of complications in hypertensive patients with diabetes mellitus. However, some reports have shown that it is difficult to control the blood pressure and the concomitant use of a plurality of drugs is needed in hypertensive patients with diabetes mellitus. In recent years renin-angiotensin system depressants are increasingly used for the blood pressure control in diabetic patients. Particularly in Japan, angiotensin II (A II) antagonists are increasingly used. However, there is no definite evidence of the point of which is efficient for the control, the increase in dose of A II antagonist or the concomitant use of another drug, in hypertensive patients whose blood pressure levels are inadequately controlled with A II antagonist. Methods/Design Hypertensive patients of age 20 years or over with type 2 diabetes mellitus who have been treated by the single use of AII antagonist at usual doses for at least 8 weeks or patients who have been treated by the concomitant use of AII antagonist and an antihypertensive drug other than calcium channel blockers and ACE inhibitors at usual doses for at least 8 weeks are included. Discussion We designed a multi-center, prospective, randomized, open label, blinded-endpoint trial, ADVANCED-J, to compare the increases in dose of A II antagonist and the concomitant use of a Ca-channel blocker (amlodipine) and A II antagonist in hypertensive patients with diabetes mellitus, whose blood pressure levels were inadequately controlled with A II antagonist. This study is different from the usual previous studies in that home blood pressures are assessed as indicators of evaluation of blood pressure. The ADVANCED-J study may have much influence on selection of antihypertensive drugs for

  13. Informed shared decision-making programme on the prevention of myocardial infarction in type 2 diabetes: a randomised controlled trial

    PubMed Central

    Buhse, Susanne; Mühlhauser, Ingrid; Heller, Tabitha; Kuniss, Nadine; Müller, Ulrich Alfons; Kasper, Jürgen; Lehmann, Thomas; Lenz, Matthias

    2015-01-01

    Objective To evaluate an informed shared decision-making programme (ISDM-P) for people with type 2 diabetes under high fidelity conditions. Design Randomised, single-blinded trial with sham control intervention and follow-up of 6 months. Setting Single-centre diabetes clinic providing care according to the national disease management programme in Germany. Participants 154 people with type 2 diabetes without diagnosis of ischaemic heart disease or stroke. Interventions The ISDM-P is executed by diabetes educators. Core component is a patient decision aid on the prevention of myocardial infarction supplemented by a 90 min group teaching session. The structurally equivalent control intervention addresses stress issues. Main outcome measures Primary outcome was risk comprehension, including realistic expectations about benefits and harms of interventions. It was assessed by a 12-item questionnaire after the teaching session when patients set and prioritise their treatment goals. Key secondary outcome was adherence to treatment goals, operationalised as achievement of individual goals and medication uptake. ISDM-P teaching sessions were video-taped to monitor intervention fidelity. Results 72 of 77 ISDM-P and 71 of 77 control patients completed the questionnaire (score 0–12). ISDM-P patients achieved higher levels of risk comprehension, mean score 8.25 vs 2.62, difference 5.63 (95% CI 4.82 to 6.44), and realistic expectations (score 0–6), 4.51 vs 0.85, 3.67 (3.23 to 4.11). More ISDM-P patients wished to take statins, 59.2% vs 30.4%, 28.7% (12.9% to 44.5%); more prioritised blood pressure control, 51.4% vs 25.7%, and fewer intensive glucose control, 33.3% vs 60%, p=0.002. More ISDM-P patients achieved their glycated haemoglobin goals, 95.8% vs 85.7%, 10.1% (0.6% to 19.5%). Achievement of prioritised goals and medication uptake were comparable between groups. Conclusions The ISDM-P on preventive measures in type 2 diabetes was effective under high fidelity

  14. Public affairs plan

    SciTech Connect

    Not Available

    1994-09-01

    The purpose of the Uranium Mill Tailings Remedial Action (UMTRA) Project Public Affairs Plan is to establish goals for the Fiscal Year 1995 UMTRA public affairs program and identify specific activities to be conducted during the year. It also describes the roles of various agencies involved in the conduct of the public affairs program and defines the functions of the Technical Assistance Contractor (TAC) Public Affairs Department. It integrates and replaces the Public Participation Plan (DOE/AL/62350-47D) and Public Information Plan (DOE/AL/623590-71). The plan describes the US Department of Energy`s (DOE) plans to keep stakeholders and other members of the public informed about project policies, plans, and activities, and provide opportunities for stakeholders and interested segments of the public to participate in project decision-making processes. The plan applies to the UMTRA Project Office; the DOE Albuquerque Operations Office, Office of Intergovernmental and External Affairs (OIEA); the UMTRA TAC; the UMTRA Remedial Action Contractor (RAC); and other cooperating agencies.

  15. Intensive Weight Loss Intervention in Older Individuals: Results from the Action for Health in Diabetes Type 2 Diabetes Mellitus Trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    OBJECTIVES: To compare the effects of 4 years of intensive lifestyle intervention on weight, fitness, and cardiovascular disease risk factors in older and younger individuals. DESIGN: Randomized controlled clinical trial. SETTING: Sixteen U.S. clinical sites. PARTICIPANTS: Individuals with type 2 di...

  16. Parental Characteristics Associated With Outcomes in Youth With Type 2 Diabetes: Results From the TODAY Clinical Trial

    PubMed Central

    Weinstock, Ruth S.; Trief, Paula M.; Goland, Robin; McKay, Siripoom; Milaszewski, Kerry; Preske, Jeff; Willi, Steven; Yasuda, Patrice M.

    2015-01-01

    OBJECTIVE This study examined parental factors associated with outcomes of youth in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial. RESEARCH DESIGN AND METHODS Of 699 youth with type 2 diabetes in the TODAY cohort, 623 (89.1%) had a parent participate and provide data at baseline, including weight, HbA1c, blood pressure, symptoms of depression, binge eating (BE), and medical history. Youth were followed 2–6.5 years. Data were analyzed using regression models and survival curve methods. RESULTS Parental diabetes (43.6% of parents) was associated with higher baseline HbA1c (P < 0.0001) and failure of youths to maintain glycemic control on study treatment (53.6% vs. 38.2% failure rate among those without a diabetic parent, P = 0.0002). Parental hypertension (40.6% of parents) was associated with hypertension in youth during TODAY (40.4% vs. 27.4% of youth with and without parental hypertension had hypertension, P = 0.0008) and with higher youth baseline BMI z scores (P = 0.0038). Parents had a mean baseline BMI of 33.6 kg/m2. Parental obesity (BMI >30 kg/m2) was associated with higher baseline BMI z scores in the youth (P < 0.0001). Depressive symptoms in parents (20.6% of parents) were related to youth depressive symptoms at baseline only (P = 0.0430); subclinical BE in parents was related to the presence of subclinical BE (P = 0.0354) and depressive symptoms (P = 0.0326) in youth throughout the study period. CONCLUSIONS Parental diabetes and hypertension were associated with lack of glycemic control, hypertension, and higher BMI z scores in youth. Further research is needed to better understand and address parental biological and behavioral factors to improve youth health outcomes. PMID:25784663

  17. Autologous platelet-rich gel for treatment of diabetic chronic refractory cutaneous ulcers: A prospective, randomized clinical trial.

    PubMed

    Li, Lan; Chen, Dawei; Wang, Chun; Yuan, Nanbing; Wang, Yan; He, Liping; Yang, Yanzhi; Chen, Lihong; Liu, Guanjian; Li, Xiujun; Ran, Xingwu

    2015-01-01

    The purpose of the study is to examine the safety and effectiveness of topical autologous platelet-rich gel (APG) application on facilitating the healing of diabetic chronic refractory cutaneous ulcers. The study was designed as a prospective, randomized controlled trial between January 1, 2007 and December 31, 2011. Eligible inpatients at the Diabetic Foot Care Center of West China Hospital, Sichuan University (China) were randomly prescribed with a 12-week standard treatment of ulcers (the control group) or standard treatment plus topical application APG (the APG group). The wound healing grades (primary endpoint), time to complete healing, and healing velocity within 12 weeks were monitored as short-term effectiveness measurements, while side effects were documented safety endpoints. The rates of survival and recurrence within the follow up were recorded as long-term effectiveness endpoints. Analysis on total diabetic ulcers (DUs) (n = 117) and subgroup analysis on diabetic foot ulcers (DFUs) (n = 103) were both conducted. Standard treatment plus APG treatment was statistically more effective than standard treatment (p < 0.05 in both total DUs and subgroup of DFUs). The subjects defined as healing grade 1 were 50/59 (84.8%) in total DUs and 41/48 (85.4%) in DFUs in the APG group compared with 40/58 (69.0%) and 37/55 (67.3%) in the control group from intent to treat population. The Kaplan-Meier time-to-healing were significantly different between the two groups (p < 0.05 in both total DUs and subgroup of DFUs). No side effects were identified after topical APG application. The long-term survival and recurrence rates were comparative between groups (p > 0.05). This study shows that topical APG application plus standard treatment is safe and quite effective on diabetic chronic refractory cutaneous ulcers, compared with standard treatment. PMID:25847503

  18. The impact of supported telemetric monitoring in people with type 2 diabetes: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Diabetes prevalence is increasing and current methods of management are unsustainable. Effective approaches to supporting self-management are required. The aim of this randomized controlled trial is to establish whether supported telemetric monitoring of glycemic control and blood pressure results in reductions in glycosylated hemoglobin (HbA1c; the primary outcome of a measure of long-term glycemic control) and secondary outcomes of blood pressure and weight among people with poorly controlled diabetes compared to a control group receiving usual care. Methods/Design Design: multi-center, randomized controlled trial with embedded qualitative study. Setting: primary care in Lothian, Kent, Glasgow and Borders regions in the UK. Participants: people with type 2 diabetes and confirmed HbA1c >7.5% (58 mmol/mol). Intervention/comparison: randomization to intervention or control groups will be performed by the Edinburgh Clinical Trials Unit. Participants in the intervention group will be shown how to use blood glucose and blood pressure monitors and weighing scales which use Bluetooth wireless technology to transmit readings via modem to a remote server. These participants will be asked to provide at least twice weekly measurements of morning and evening blood glucose and weekly measurements of weight and blood pressure. Measurements will be checked at least weekly by practice nurses who will contact the patients to adjust therapy according to guidelines and reinforce lifestyle advice. Participants in the control group will receive usual care. All participants will receive an individual education session. Follow-up: measurements will be performed at practices 9 months after randomization by research nurses blinded to allocation. The primary outcome measure is HbA1c and secondary outcomes measure are daytime systolic and diastolic blood pressure, weight and cost per quality-adjusted life year. Analysis: intention-to-treat analyses will be performed. The sample

  19. Lifestyle change in Kerala, India: needs assessment and planning for a community-based diabetes prevention trial

    PubMed Central

    2013-01-01

    Background Type 2 Diabetes Mellitus (T2DM) has become a major public health challenge in India. Factors relevant to the development and implementation of diabetes prevention programmes in resource-constrained countries, such as India, have been under-studied. The purpose of this study is to describe the findings from research aimed at informing the development and evaluation of a Diabetes Prevention Programme in Kerala, India (K-DPP). Methods Data were collected from three main sources: (1) a systematic review of key research literature; (2) a review of relevant policy documents; and (3) focus groups conducted among individuals with a high risk of progressing to diabetes. The key findings were then triangulated and synthesised. Results Prevalence of risk factors for diabetes is very high and increasing in Kerala. This situation is largely attributable to rapid changes in the lifestyle of people living in this state of India. The findings from the systematic review and focus groups identified many environmental and personal determinants of these unhealthy lifestyle changes, including: less than ideal accessibility to and availability of health services; cultural values and norms; optimistic bias and other misconceptions related to risk; and low expectations regarding one’s ability to make lifestyle changes in order to influence health and disease outcomes. On the other hand, there are existing intervention trials conducted in India which suggests that risk reduction is possible. These programmes utilize multi-level strategies including mass media, as well as strategies to enhance community and individual empowerment. India’s national programme for the prevention and control of major non-communicable diseases (NCD) also provide a supportive environment for further community-based efforts to prevent diabetes. Conclusion These findings provide strong support for undertaking more research into the conduct of community-based diabetes prevention in the rural areas of

  20. A low-fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74-wk clinical trial1234

    PubMed Central

    Barnard, Neal D; Cohen, Joshua; Jenkins, David JA; Turner-McGrievy, Gabrielle; Gloede, Lise; Green, Amber; Ferdowsian, Hope

    2009-01-01

    Background: Low-fat vegetarian and vegan diets are associated with weight loss, increased insulin sensitivity, and improved cardiovascular health. Objective: We compared the effects of a low-fat vegan diet and conventional diabetes diet recommendations on glycemia, weight, and plasma lipids. Design: Free-living individuals with type 2 diabetes were randomly assigned to a low-fat vegan diet (n = 49) or a diet following 2003 American Diabetes Association guidelines (conventional, n = 50) for 74 wk. Glycated hemoglobin (Hb A1c) and plasma lipids were assessed at weeks 0, 11, 22, 35, 48, 61, and 74. Weight was measured at weeks 0, 22, and 74. Results: Weight loss was significant within each diet group but not significantly different between groups (−4.4 kg in the vegan group and −3.0 kg in the conventional diet group, P = 0.25) and related significantly to Hb A1c changes (r = 0.50, P = 0.001). Hb A1c changes from baseline to 74 wk or last available values were −0.34 and −0.14 for vegan and conventional diets, respectively (P = 0.43). Hb A1c changes from baseline to last available value or last value before any medication adjustment were −0.40 and 0.01 for vegan and conventional diets, respectively (P = 0.03). In analyses before alterations in lipid-lowering medications, total cholesterol decreased by 20.4 and 6.8 mg/dL in the vegan and conventional diet groups, respectively (P = 0.01); LDL cholesterol decreased by 13.5 and 3.4 mg/dL in the vegan and conventional groups, respectively (P = 0.03). Conclusions: Both diets were associated with sustained reductions in weight and plasma lipid concentrations. In an analysis controlling for medication changes, a low-fat vegan diet appeared to improve glycemia and plasma lipids more than did conventional diabetes diet recommendations. Whether the observed differences provide clinical benefit for the macro- or microvascular complications of diabetes remains to be established. This trial was registered at clinicaltrials

  1. Early Urinary Markers of Diabetic Kidney Disease: A Nested Case-Control Study From the Diabetes Control and Complications Trial (DCCT)

    PubMed Central

    Kern, Elizabeth O; Erhard, Penny; Sun, Wanjie; Genuth, Saul; Weiss, Miriam F

    2010-01-01

    Background Urinary markers were tested as predictors of macroalbuminuria or microalbuminuria in type 1 diabetes. Study Design Nested case:control of participants in the Diabetes Control and Complications Trial (DCCT) Setting & Participants Eighty-seven cases of microalbuminuria were matched to 174 controls in a 1:2 ratio, while 4 cases were matched to 4 controls in a 1:1 ratio, resulting in 91 cases and 178 controls for microalbuminuria. Fifty-five cases of macroalbuminuria were matched to 110 controls in a 1:2 ratio. Controls were free of micro/macroalbuminuria when their matching case first developed micro/macroalbuminuria. Predictors Urinary N-acetyl-β-D-glucosaminidase, pentosidine, AGE fluorescence, albumin excretion rate (AER) Outcomes Incident microalbuminuria (two consecutive annual AER > 40 but <= 300 mg/day), or macroalbuminuria (AER > 300 mg/day) Measurements Stored urine samples from DCCT entry, and 1–9 years later when macroalbuminuria or microalbuminuria occurred, were measured for the lysosomal enzyme, N-acetyl-β-D-glucosaminidase, and the advanced glycosylation end-products (AGEs) pentosidine and AGE-fluorescence. AER and adjustor variables were obtained from the DCCT. Results Sub-microalbuminuric levels of AER at baseline independently predicted microalbuminuria (adjusted OR 1.83; p<.001) and macroalbuminuria (adjusted OR 1.82; p<.001). Baseline N-acetyl-β-D-glucosaminidase independently predicted macroalbuminuria (adjusted OR 2.26; p<.001), and microalbuminuria (adjusted OR 1.86; p<.001). Baseline pentosidine predicted macroalbuminuria (adjusted OR 6.89; p=.002). Baseline AGE fluorescence predicted microalbuminuria (adjusted OR 1.68; p=.02). However, adjusted for N-acetyl-β-D-glucosaminidase, pentosidine and AGE-fluorescence lost predictive association with macroalbuminuria and microalbuminuria, respectively. Limitations Use of angiotensin converting-enzyme inhibitors was not directly ascertained, although their use was proscribed during the

  2. Cognitive behavioural therapy in elderly type 2 diabetes patients with minor depression or mild major depression: study protocol of a randomized controlled trial (MIND-DIA)

    PubMed Central

    2010-01-01

    Background The global prevalence of diabetes among adults will be 6.4% in 2010 and will increase to 7.7% by 2030. Diabetes doubles the odds of depression, and 9% of patients with diabetes are affected by depressive disorders. When subclinical depression is included, the proportion of patients who have clinically relevant depressive symptoms increases to 26%. In patients aged over 65 years, the interaction of diabetes and depression has predicted increased mortality, complications, disability, and earlier occurrence of all of these adverse outcomes. These deleterious effects were observed even in minor depression, where the risk of mortality within 7 years was 4.9 times higher compared with diabetes patients who did not have depressive symptoms. In this paper we describe the design and methods of the Minor Depression and Diabetes trial, a clinical trial within the 'Competence Network for Diabetes mellitus', which is funded by the German Federal Ministry of Education and Research. Methods/Design Patients' inclusion criteria are: Type 2 diabetes mellitus, 65 to 85 years of age, 3 to 6 depressive symptoms (minor depression or mild major depression). Our aim is to compare the efficacy of diabetes-specific cognitive behavioural therapy adapted for the elderly vs. intensified treatment as usual vs. a guided self-help intervention regarding improvement of health related quality of life as the primary outcome. The trial will be conducted as a multicentre, open, observer-blinded, parallel group (3 groups) randomized controlled trial. Patients will be randomized to one of the three treatment conditions. After 12 weeks of open-label therapy in all treatment conditions, both group interventions will be reduced to one session per month during the one-year long-term phase of the trial. At the one-year follow-up, all groups will be re-examined regarding the primary and secondary parameters, for example reduction of depressive symptoms, prevention of moderate/severe major

  3. Comparison of Azelnidipine and Trichlormethiazide in Japanese Type 2 Diabetic Patients with Hypertension: The COAT Randomized Controlled Trial

    PubMed Central

    Takihata, Masahiro; Nakamura, Akinobu; Kondo, Yoshinobu; Kawasaki, Satsuki; Kimura, Mari; Terauchi, Yasuo

    2015-01-01

    Objective This study compared the efficacy and safety of azelnidipine with that of trichlormethiazide in Japanese type 2 diabetic patients with hypertension. Methods In a multicenter, open-label trial, 240 patients with adequately controlled diabetes (HbA1c ≤ 7.0%) under lifestyle modification and/or administration of hypoglycemic agents and inadequately controlled hypertension (systolic blood pressure [sBP] ≥ 130 mmHg or diastolic blood pressure [dBP] ≥ 80 mmHg) who were being treated with olmesartan were enrolled. Participants were randomly assigned to an azelnidipine group or a trichlormethiazide group and were followed up for 48 weeks. Main outcome measure was the difference in the change in HbA1c levels from the baseline values at 48 weeks between these two groups. Results Of the 240 subjects that were enrolled, 209 subjects (azelnidipine group: 103 patients, trichlormethiazide group: 106 patients) completed this trial. At 48 weeks, the following changes were observed in the azelnidipine and trichlormethiazide groups, respectively: HbA1c levels, 0.19 ± 0.52% and 0.19 ± 0.54%; sBP/dBP, -10.7 ± 9.6/-6.6 ± 6.6 mmHg and -7.1 ± 7.7/-3.3 ± 6.1 mmHg (P < 0.001 for both sBP and dBP). In both groups, dizziness (12 patients [11.7%] and 16 patients [15.1%]) and edema (16 patients [15.5%] and 7 patients [6.6%], P = 0.047) were observed during the 48-week follow-up period. Conclusions Azelnidipine was more effective for controlling blood pressure than trichlormethiazide in Japanese type 2 diabetes patients, whereas trichlormethiazide was more effective for reducing albuminuria than azelnidipine. Both of these agents, however, similarly exacerbated glycemic control in type 2 diabetic patients with hypertension. Trial Registration UMIN 000006081. PMID:25938807

  4. Effects of aggressive cholesterol lowering and low-dose anticoagulation on clinical and angiographic outcomes in patients with diabetes: the Post Coronary Artery Bypass Graft Trial.

    PubMed

    Hoogwerf, B J; Waness, A; Cressman, M; Canner, J; Campeau, L; Domanski, M; Geller, N; Herd, A; Hickey, A; Hunninghake, D B; Knatterud, G L; White, C

    1999-06-01

    Diabetic patients have greater risk for coronary heart disease (CHD) events after coronary artery bypass graft (CABG) surgery than nondiabetic patients. The Post CABG trial studied the effects of aggressive cholesterol lowering and low-dose anticoagulation in diabetic patients compared with nondiabetic patients. A double-blind, randomized clinical trial in 1,351 patients (1-11 years after CABG), the Post CABG trial consisted of two interventions (aggressive cholesterol-lowering versus moderate lowering and low-dose warfarin versus placebo) on angiographic end points. Angiographic changes in saphenous vein graft conduits 4.3 years after entry were compared in 116 diabetic and 1,235 nondiabetic patients. Seven clinical centers participated in the trial, as well as the National Institutes of Health project office (National Heart, Lung, and Blood Institute), the coordinating center (Maryland Medical Research Institute), and the Angiogram Reading Center (University of Minnesota). Baseline characteristics of the diabetic patients differed from the nondiabetic patients in the following ways: percentage of women participants, 15 vs. 7%, P = 0.002; mean baseline weight, 87.4 vs. 82.8 kg, P = 0.006; mean BMI, 29.5 vs. 27.6 kg/m2, P = 0.0002; mean systolic blood pressure, 141.7 vs. 133.6, P < 0.0001; mean triglyceride concentrations, 2.09 vs. 1.77 mmol/l, P < 0.0001; and mean HDL cholesterol concentrations, 0.93 vs. 1.02 mmol, P = 0.0001. The percentage of clinical events was higher in diabetic than nondiabetic patients (20.6 vs. 13.4, P = 0.033) and angiographic outcomes were not different. The benefits of aggressive cholesterol lowering were comparable in diabetic and nondiabetic patients for the angiographic end points. Warfarin use was not associated with clinical or angiographic benefit. Diabetic patients in the Post CABG trial had more CHD risk factors at study entry and higher clinical event rates during the study than nondiabetic patients. The benefits of aggressive

  5. Multisystemic therapy for adolescents with poorly controlled type I diabetes: Stability of treatment effects in a randomized controlled trial.

    PubMed

    Ellis, Deborah A; Templin, Thomas; Naar-King, Sylvie; Frey, Maureen A; Cunningham, Phillippe B; Podolski, Cheryl-Lynn; Cakan, Nedim

    2007-02-01

    The primary purpose of the present study was to determine whether multisystemic therapy (MST), an intensive, home-based psychotherapy, improved regimen adherence, metabolic control, and rates of hospitalization for diabetic ketoacidosis (DKA) among adolescents with chronically poorly controlled Type 1 diabetes 6 months after the completion of treatment. A randomized controlled trial was conducted with 127 adolescents and their families. Mean participant age was 13.2 years. Sixty-three percent of participants were African American, and 51% were female. Data were collected at baseline, treatment termination, and 6-month follow-up. Changes in glycated hemoglobin (HbA1c), frequency of blood glucose testing (BGT), and rate of DKA admissions were assessed. In intent-to-treat analyses, a main effect of MST on DKA admissions was found at both treatment termination and follow-up. Improvements in BGT were moderated by family composition; only 2-parent MST families maintained improvements at follow-up. Improvements in HbA1c for the MST group at treatment termination were lost at follow-up. Results show that intensive, home-based psychotherapy created stable reductions in serious lapses in adherence, as indexed by episodes of DKA, among youth with poorly controlled diabetes. PMID:17295576

  6. Effect of Camel Milk on Blood Sugar and Lipid Profile of Patients With Type 2 Diabetes: A Pilot Clinical Trial

    PubMed Central

    Ejtahed, Hanieh Sadat; Niasari Naslaji, Amir; Mirmiran, Parvin; Zraif Yeganeh, Maryam; Hedayati, Mehdi; Azizi, Fereidoun; Moosavi Movahedi, Aliakbar

    2015-01-01

    Background: It has been shown that camel milk consumption has a definite decreasing effect on the prevalence of diabetes. However, most of these studies were conducted on patients with type 1 diabetes, whereas studies on patients with type 2 diabetes mellitus (T2DM) are limited. In vitro experiments have shown that camel milk was able to decrease blood glucose concentration. Objectives: The purpose of this study was to investigate effects of camel and cow milk on blood sugar, lipid profile, and blood pressure of patients with T2DM. Patients and Methods: In a randomized single-blinded controlled clinical trial, 20 patients with T2DM were randomly allocated into two groups. Participants consumed 500 mL of either camel milk (intervention group) or cow milk (control group) daily for two months. Results: Mean of insulin concentration was significantly increased from 64.59 to 84.03 pmol/L in the camel milk group during the study (P < 0.05). No significant differences were shown in fasting blood sugar, lipid profile, and blood pressure between the two groups at the end of study. There was significant increase in homeostasis model assessment of insulin resistance (HOMA-IR) during the study in both groups, but no significant difference was seen between the two groups. Conclusions: Camel milk increased insulin level in patients with T2DM and might contribute to glycemic control in T2DM. PMID:25745496

  7. Erectile Dysfunction in Type 2 Diabetic Men: Relationship to Exercise Fitness and Cardiovascular Risk Factors in the Look AHEAD Trial

    PubMed Central

    Rosen, Raymond C.; Wing, Rena R.; Schneider, Stephen; Wadden, Thomas A.; Foster, Gary D.; West, Delia Smith; Kitabchi, Abbas E.; Brancati, Frederick L.; Maschak-Carey, Barbara J.; Bahnson, Judy L.; Lewis, Cora E.; Gendrano, Isaias N.

    2016-01-01

    Introduction Determinants of erectile dysfunction in diabetic men have not been adequately investigated as potential mediators of change. Aim To determine the prevalence and correlates of erectile dysfunction (ED) in overweight men with type 2 diabetes in the multicenter, Look AHEAD trial (Action for Health in Diabetes). Main Outcome Measures International Index of Erectile Function (IIEF), self-reported use of phosphodiesterase type 5 inhibitors, laboratory measures of adiposity, cardiometabolic parameters, and exercise fitness. Methods Male participants aged 45–75 in the Look AHEAD trial in a committed relationship were recruited for an ongoing study of sexual function and diabetes. Eligible participants completed the IIEF questionnaire and provided updated information on use of medical treatments for sexual dysfunction. Baseline sexual function results for participants in the male ancillary study are reported here; intervention data and results for female participants are presented elsewhere. Results A total of 373 eligible male participants completed all sexual function questionnaires, of whom 263 (68.7%) were sexually active at the time of the study. Almost half (49.8%) of the men reported mild or moderate degrees of ED, and 24.8% had complete ED. Among sexually active participants, 42.6% had sought medical help for their problem, and 39.7% reported use of ED medications. ED was significantly associated with age (odds ratio [OR] = 1.05; confidence interval [CI]: 1.01–1.10) baseline HbA1c (OR = 1.31; CI: 1.05–1.63), hypertension history (OR = 2.41; CI: 1.34–4.36), and metabolic syndrome (OR = 3.05, CI: 1.31–7.11). Of note, cardiorespiratory fitness was found to be protective of ED in a multivariable analysis (OR = 0.61; P < 0.001). Conclusions ED is prevalent in this sample of obese, type 2 diabetic men in the Look AHEAD study. Cardiovascular risk factors were highly associated with ED in this population, and cardiorespiratory fitness was protective

  8. Adjustable Gastric Band Surgery or Medical Management in Patients With Type 2 Diabetes: A Randomized Clinical Trial

    PubMed Central

    Ding, Su-Ann; Simonson, Donald C.; Wewalka, Marlene; Halperin, Florencia; Foster, Kathleen; Goebel-Fabbri, Ann; Hamdy, Osama; Clancy, Kerri; Lautz, David; Vernon, Ashley

    2015-01-01

    Context: Recommendations for surgical, compared with lifestyle and pharmacologically based, approaches for type 2 diabetes (T2D) management remain controversial. Objective: The objective was to compare laparoscopic adjustable gastric band (LAGB) to an intensive medical diabetes and weight management (IMWM) program for T2D. Design: This was designed as a prospective, randomized clinical trial. Setting: The setting was two Harvard Medical School-affiliated academic institutions. Interventions and Participants: A 12-month randomized trial comparing LAGB (n = 23) vs IMWM (n = 22) in persons aged 21–65 years with body mass index of 30–45 kg/m2, T2D diagnosed more than 1 year earlier, and glycated hemoglobin (HbA1c) ≥ 6.5% on antihyperglycemic medication(s). Main Outcome Measure: The proportion meeting the prespecified primary glycemic endpoint, defined as HbA1c < 6.5% and fasting glucose < 7.0 mmol/L at 12 months, on or off medication. Results: After randomization, five participants did not undergo the surgical intervention. Of the 40 initiating intervention (22 males/18 females; age, 51 ± 10 y; body mass index, 36.5 ± 3.7 kg/m2; diabetes duration, 9 ± 5 y; HbA1c, 8.2 ± 1.2%; 40% on insulin), the proportion meeting the primary glycemic endpoint was achieved in 33% of the LAGB patients and 23% of the IMWM patients (P = .457). HbA1c reduction was similar between groups at both 3 and 12 months (−1.2 ± 0.3 vs −1.0 ± 0.3%; P = .496). Weight loss was similar at 3 months but greater 12 months after LAGB (−13.5 ± 1.7 vs −8.5 ± 1.6 kg; P = .027). Systolic blood pressure reduction was greater after IMWM than LAGB, whereas changes in diastolic blood pressure, lipids, fitness, and cardiovascular risk scores were similar between groups. Patient-reported health status, assessed using the Short Form-36, Impact of Weight on Quality of Life, and Problem Areas in Diabetes, all improved similarly between groups. Conclusions: LAGB and a multidisciplinary IMWM program

  9. Influence of Total Coronary Occlusion on Clinical Outcomes (from the Bypass Angioplasty Revascularization Investigation 2 DiabetesTrial).

    PubMed

    Damluji, Abdulla A; Pomenti, Sydney F; Ramireddy, Archana; Al-Damluji, Mohammed S; Alfonso, Carlos E; Schob, Alan H; Marso, Steven P; Gilchrist, Ian C; Moscucci, Mauro; Kandzari, David E; Cohen, Mauricio G

    2016-04-01

    Our aim was to evaluate the influence of chronic total occlusions (CTOs) on long-term clinical outcomes of patients with coronary heart disease and diabetes mellitus. We evaluated patients with coronary heart disease and diabetes mellitus enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes, who underwent either prompt revascularization (PR) with intensive medical therapy (IMT) or IMT alone according to the presence or absence of CTO. Of 2,368 patients enrolled in the trial, 972 patients (41%) had CTO of coronary arteries. Of those, 482 (41%) and 490 (41%) were in the PR with IMT versus IMT only groups, respectively. In the PR group, patients with CTO were more likely to be selected for the coronary artery bypass grafting stratum (coronary artery bypass grafting 62% vs percutaneous coronary intervention 31%, p <0.001). Compared to the non-CTO group, patients with CTO had more abnormal Q wave, abnormal ST depression, and abnormal T waves. The myocardial jeopardy score was higher in the CTO versus non-CTO group (52 [36 to 69] vs 37 [21 to 53], p <0.001). After adjustment, 5-year mortality rate was significantly higher in the CTO group in the entire cohort (hazard ratio [HR] 1.35, p = 0.013) and in patients with CTO managed with IMT (HR 1.46, p = 0.031). However, the adjusted risk of death was not increased in patients managed with PR (HR 1.26, p = 0.180). In conclusion, CTO of coronary arteries is associated with increased mortality in patients treated medically. However, the presence of a CTO may not increase mortality in patients treated with revascularization. Larger randomized trials are needed to evaluate the effects of revascularization on long-term survival in patients with CTO. PMID:26853953

  10. Prevention of Gestational Diabetes: Design of a Cluster-Randomized Controlled Trial and One-Year Follow-Up

    PubMed Central

    2010-01-01

    Background Annual prevalence of gestational diabetes mellitus (GDM) is 12.5% among Finnish pregnant women. The prevalence is expected to rise with the increasing overweight among women before pregnancy. Physical activity and diet are both known to have favourable effects on insulin resistance and possibly on the risk of GDM. We aimed to investigate, whether GDM can be prevented by counseling on diet, physical activity and gestational weight gain during pregnancy. Methods/Design A cluster-randomized controlled trial was conducted in 14 municipalities in the southern part of Finland. Pairwise randomization was performed in order to take into account socioeconomic differences. Recruited women were at 8-12 weeks' gestation and fulfilled at least one of the following criteria: body mass index ≥ 25 kg/m2, history of earlier gestational glucose intolerance or macrosomic newborn (> 4500 g), age ≥ 40 years, first or second degree relative with history of type 1 or 2 diabetes. Main exclusion criterion was pathological oral glucose tolerance test (OGTT) at 8-12 weeks' gestation. The trial included one counseling session on physical activity at 8-12 weeks' gestation and one for diet at 16-18 weeks' gestation, and three to four booster sessions during other routine visits. In the control clinics women received usual care. Information on height, weight gain and other gestational factors was obtained from maternity cards. Physical activity, dietary intake and quality of life were followed by questionnaires during pregnancy and at 1-year postpartum. Blood samples for lipid status, hormones, insulin and OGTT were taken at 8-12 and 26-28 weeks' gestation and 1 year postpartum. Workability and return to work were elicited by a questionnaire at 1- year postpartum. Linkage to the national birth register of years 2007-2009 will provide information on perinatal complications and GDM incidence among the non-participants of the study. Cost-effectiveness evaluation will be based on

  11. Effects of a Topical Saffron (Crocus sativus L) Gel on Erectile Dysfunction in Diabetics: A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial.

    PubMed

    Mohammadzadeh-Moghadam, Hossein; Nazari, Seyed Mohammad; Shamsa, Ali; Kamalinejad, Mohammad; Esmaeeli, Habibollah; Asadpour, Amir Abbas; Khajavi, Abdoljavad

    2015-10-01

    Erectile dysfunction is a man's persistent or recurrent inability to achieve and maintain erection for a satisfactory sexual relationship. As diabetes is a major risk factor for erectile dysfunction, the prevalence of erectile dysfunction among diabetic men has been reported as 35% to 90%. This randomized, parallel-group, double-blind, placebo-controlled trial investigated the effects of a topical saffron (Crocus sativus L) gel on erectile dysfunction in diabetic men. Patients were randomly allocated to 2 equal groups (with 25 patients each). The intervention group was treated with topical saffron, and the control received a similar treatment with placebo. The 2 groups were assessed using the International Index of Erectile Function Questionnaire before the intervention and 1 month after the intervention. Compared to placebo, the prepared saffron gel could significantly improve erectile dysfunction in diabetic patients (P < .001). This preliminary evidence suggests that saffron can be considered as a treatment option for diabetic men with erectile dysfunction. PMID:25948674

  12. The impact of tailored diabetes registry report cards on measures of disease control: a nested randomized trial

    PubMed Central

    2011-01-01

    Background Most studies of diabetes self-management that show improved clinical outcome performance involve multiple, time-intensive educational sessions in a group format. Most provider performance feedback interventions do not improve intermediate outcomes, yet lack targeted, patient-level feedback. Methods 5,457 low-income adults with diabetes at eight federally-qualified community health centers participated in this nested randomized trial. Half of the patients received report card mailings quarterly; patients at 4 of 8 clinics received report cards at every clinic visit; and providers at 4 of 8 clinics received quarterly performance feedback with targeted patient-level data. Expert-recommended glycemic, lipid, and blood pressure outcomes were assessed. Assessment of report card utility and patient and provider satisfaction was conducted through mailed patient surveys and mid- and post-intervention provider interviews. Results Many providers and the majority of patients perceived the patient report card as being an effective tool. However, patient report card mailings did not improve process outcomes, nor did point-of-care distribution improve intermediate outcomes. Clinics with patient-level provider performance feedback achieved a greater absolute increase in the percentage of patients at target for glycemic control compared to control clinics (6.4% vs 3.8% respectively, Generalized estimating equations Standard Error 0.014, p < 0.001, CI -0.131 - -0.077). Provider reaction to performance feedback was mixed, with some citing frustration with the lack of both time and ancillary resources. Conclusions Patient performance report cards were generally well received by patients and providers, but were not associated with improved outcomes. Targeted, patient-level feedback to providers improved glycemic performance. Provider frustration highlights the need to supplement provider outreach efforts. Trial Registration ClinicalTrials.gov: NCT00827710 PMID:21329495

  13. Diabetes Nurse Case Management and Motivational Interviewing for Change (DYNAMIC): Results of a 2-year Randomized Controlled Pragmatic Trial

    PubMed Central

    Gabbay, Robert A.; Añel-Tiangco, Raquel M.; Dellasega, Cheryl; Mauger, David T.; Adelman, Alan; Van Horn, Deborah H.A.

    2013-01-01

    Objective To determine if the addition of nurse case managers (NCMs) trained in motivational interviewing (MI) to usual care would result in improved outcomes in high risk type 2 diabetes patients. Methods A 2-year randomized controlled pragmatic trial randomized 545 patients to usual care control (n=313) or those who received the intervention (n= 232) with additional practice embedded NCM care, including MI-guided behavior change counseling. NCMs received intensive MI training with ongoing fidelity assessment. Results Systolic BP was better in the intervention group (131±15.9 vs. 135±18.2, p < 0.05). HbA1c, LDL, and diastolic BP improved in both groups: HbA1c (control group 9.1% to 8.0%, intervention group 8.8% to 7.8%), LDL (control group 127 to 100 mg/dL, intervention group 128 to 102 mg/dL), diastolic BP (control group 78 to 74 mm Hg, intervention group 80 to 74 mm Hg). Depression symptom scores were better in the intervention group. The reduction in diabetes-related distress approached statistical significance. Conclusions NCMs and MI improved systolic BP and complications screening. The large decrease in HbA1C and LDL in the control group may have obscured any further intervention effect. Although nurses prompted providers for medication titration, strategies to reduce provider clinical inertia might also be needed. Significant findings of the study In patients with type 2 diabetes, an intervention with nurse case management and motivational interviewing improves systolic blood pressure, depression, and screening for complications. What this study adds First study to look at the benefit of the addition of motivational interviewing to nurse case management in the care of the high-risk adult with type 2 diabetes. Particular attention was given to ensuring fidelity to the motivational interviewing approach. PMID:23368423

  14. Anatomical effects of dexamethasone intravitreal implant in diabetic macular oedema: a pooled analysis of 3-year phase III trials

    PubMed Central

    Danis, Ronald P; Sadda, Srinivas; Li, Xiao-Yan; Cui, Harry; Hashad, Yehia; Whitcup, Scott M

    2016-01-01

    Background/aim To assess long-term effects of dexamethasone intravitreal implant (DEX implant) monotherapy on retinal morphology in diabetic macular oedema (DME). Methods Two multicentre, masked, phase III studies with identical protocols randomised patients with DME, best-corrected visual acuity of 34–68 Early Treatment Diabetic Retinopathy Study letters and central subfield retinal thickness (CSRT) ≥300 µm to DEX implant 0.7, 0.35 mg or sham procedure. Patients were followed up for 3 years (39 months if treated at month 36), with retreatment allowed at ≥6-month intervals. Patients needing other macular oedema (ME) therapy exited the study. Changes from baseline in CSRT, macular volume and ME grade, area of retinal thickening, macular leakage, macular capillary loss and diabetic retinopathy severity were assessed. Results After 3 years, more eyes treated with DEX implant 0.7 and 0.35 mg than sham showed improvement (although small) in ME grade (p<0.05 vs sham). DEX implant 0.7 mg delayed time to onset of two-step progression in diabetic retinopathy severity by ∼12 months. DEX implant 0.7 and 0.35 mg produced small, non-sustained reductions in macular leakage but had no significant effect on macular capillary loss. Conclusions DEX implant 0.7 or 0.35 mg, administered at ≥6-month intervals over 3 years, produced sustained retinal structural improvement in DME. Trial registration number NCT00168337 and NCT00168389. PMID:26581718

  15. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial

    PubMed Central

    Lee, Yu-Mi; Kim, Se-A; Lee, In-Kyu; Kim, Jung-Guk; Park, Keun-Gyu; Jeong, Ji-Yun; Jeon, Jae-Han; Shin, Ji-Yeon; Lee, Duk-Hee

    2016-01-01

    Objective Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Materials and Methods Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks. Results The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks. Conclusion Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms. Trial Registration CRiS KCT0001771 PMID:27253526

  16. The Celiac Disease and Diabetes-Dietary Intervention and Evaluation Trial (CD-DIET) protocol: a randomised controlled study to evaluate treatment of asymptomatic coeliac disease in type 1 diabetes

    PubMed Central

    Mahmud, Farid H; De Melo, Emilia N; Noordin, Karima; Assor, Esther; Sahota, Kamaljeet; Davies-Shaw, Jolie; Cutz, Ernest; Somers, Gino; Lawson, Margaret; Mack, David R; Gallego, Patricia; McDonald, Charlotte; Beaton, Melanie D; Bax, Kevin; Saibil, Fred; Gilbert, Jeremy; Kirsch, Susan; Perkins, Bruce A; Cino, Maria; Szentgyorgyi, Eva; Koltin, Dror; Parikh, Amish; Mukerji, Geetha; Advani, Andrew; Lou, Olivia; Marcon, Margaret A

    2015-01-01

    Introduction Coeliac disease (CD) is an autoimmune condition characterised by gluten-induced intestinal inflammation, and observed at a 5–10 fold greater prevalence in type 1 diabetes. While universal screening for CD in patients with diabetes is frequently advocated, objective data is limited as to benefits on diabetes control, bone health or quality of life related to the adoption of a gluten-free diet (GFD) in the large proportion of patients with diabetes with asymptomatic CD. The Celiac Disease and Diabetes-Dietary Intervention and Evaluation Trial (CD-DIET) study is a multicenter, randomised controlled trial to evaluate the efficacy and safety of a GFD in patients with type 1 diabetes with asymptomatic CD. Methods and analysis Children and adults (8–45 years) with type 1 diabetes will be screened for asymptomatic CD. Eligible patients with biopsy-proven CD will be randomly assigned in a 1:1 ratio to treatment with a GFD for 1 year, or continue with a gluten-containing diet. The primary outcome will evaluate the impact of the GFD on change in glycated haemoglobin. Secondary outcomes will evaluate changes in bone mineral density, blood glucose variability and health-related quality of life between GFD-treated and the regular diet group over a 1-year period. The study was initiated in 2012 and has subsequently expanded to multiple paediatric and adult centres in Ontario, Canada. Ethics and dissemination The findings from this study will provide high-quality evidence as to the impact of GFD treatment on glycaemic control and complications in asymptomatic children and adults with CD and type 1 diabetes. Trial registration number NCT01566110. PMID:25968008

  17. Peer Support for Achieving Independence in Diabetes (Peer-AID): Design, methods and baseline characteristics of a randomized controlled trial of community health worker assisted diabetes self-management support

    PubMed Central

    Nelson, Karin; Drain, Nathan; Robinson, June; Kapp, Janet; Hebert, Paul; Taylor, Leslie; Silverman, Julie; Kiefer, Meghan; Lessler, Dan; Krieger, James

    2014-01-01

    Background & Objectives Community health workers (CHWs) may be an important mechanism to provide diabetes self-management to disadvantaged populations. We describe the design and baseline results of a trial evaluating a home-based CHW intervention. Methods & Research Design Peer Support for Achieving Independence in Diabetes (Peer-AID) is a randomized, controlled trial evaluating a home-based CHW-delivered diabetes self-management intervention versus usual care. The study recruited participants from 3 health systems. Change in A1c measured at 12 months is the primary outcome. Change in blood pressure, lipids, health care utilization, health-related quality of life, self-efficacy and diabetes self-management behaviors at 12 months are secondary outcomes. Results A total of 1,438 patients were identified by medical record review as potentially eligible, 445 patients were screened by telephone for eligibility and 287 were randomized. Groups were comparable at baseline on socio-demographic and clinical characteristics. All participants were low-income and were from diverse racial and ethnic backgrounds. The mean A1c was 8.9%, mean BMI was above the obese range, and non-adherence to diabetes medications was high. The cohort had high rates of co-morbid disease and low self-reported health status. Although one-third reported no health insurance, the mean number of visits to a physician in the past year was 5.7. Trial results are pending. Conclusions Peer-AID recruited and enrolled a diverse group of low income participants with poorly controlled type 2 diabetes and delivered a home-based diabetes self-management program. If effective, replication of the Peer-AID intervention in community based settings could contribute to improved control of diabetes in vulnerable populations. PMID:24956324

  18. Prospective clinical trial of hepatitis B vaccination in adults with and without type-2 diabetes mellitus

    PubMed Central

    Van Der Meeren, Olivier; Peterson, James T.; Dionne, Marc; Beasley, Richard; Ebeling, Peter R.; Ferguson, Murdo; Nissen, Michael D.; Rheault, Paul; Simpson, Richard W.; De Ridder, Marc; Crasta, Priya D.; Miller, Jacqueline M.; Trofa, Andrew F.

    2016-01-01

    ABSTRACT  Objective: Patients with diabetes mellitus are at increased risk for hepatitis B virus (HBV) infection and its complications. HBV vaccination is recommended for adults with diabetes in the United States and other countries. However, few studies have assessed safety and immunogenicity of hepatitis B vaccine in such patients. We assessed the safety and immunogenicity of recombinant hepatitis B vaccine in subjects with and without diabetes mellitus. Methods: Prospective, multi-country controlled study in 21 centers (www.clinicaltrials.gov NCT01627340). Four hundred and sixteen participants with Type-2 diabetes and 258 controls matched for age and body mass index (BMI) (2:1 ratio) received 3-doses of HBV vaccine (Engerix-B™, GSK Vaccines, Belgium) according to a 0, 1, 6 months schedule. Antibodies were measured against HBV surface antigen and expressed as seroprotection rates (anti-HBs ≥10mIU/mL) and geometric mean concentration (GMC). Results: The median age and BMI in patients with diabetes and controls (according-to-protocol cohort) were 54 y and 32.1 kg/m2, and 53 y and 30.8 kg/m2, respectively. Seroprotection rates (GMCs) one month post-dose-3 were 75.4% (147.6 mIU/mL) and 82.0% (384.2 mIU/mL) in patients with diabetes and controls, respectively. Age-stratified seroprotection rates for patients with diabetes were 88.5% (20–39 years), 81.2% (40–49 years), 83.2% (50–59 years), and 58.2% (≥60 years). The overall safety profile of hepatitis B vaccine was similar between groups. Conclusions: Hepatitis B vaccine is immunogenic in patients with diabetes and has a similar safety profile to vaccination in healthy controls. Because increasing age was generally associated with a reduction in seroprotection rates, hepatitis B vaccine should be administered as soon as possible after the diagnosis of diabetes. PMID:27123743

  19. Inclusion of Ethnic Minorities in Telehealth Trials for Type 2 Diabetes: Protocol for a Systematic Review Examining Prevalence and Language Issues

    PubMed Central

    Rooshenas, Leila

    2016-01-01

    Background Type 2 diabetes is common, on the rise, and disproportionately affects ethnic minority groups. Telehealth interventions may mitigate diabetes-related complications, but might under-recruit or even exclude ethnic minorities, in part because of English language requirements. The under-representation of minority patients in trials could threaten the generalizability of the findings, whereby the patients who might stand to benefit most from such interventions are not being included in their evaluation. Objective The aims of this systematic review are twofold: (1) to assess the reporting and prevalence of ethnic minorities in published telehealth trials for type 2 diabetes, including identifying trial features associated with successful patient recruitment; and (2) to determine the proportion of such trials that report English language proficiency as an inclusion/exclusion criterion, including how and why they do so. Methods Randomized controlled trials (RCTs) of adults with type 2 diabetes in Western, English-speaking countries that included telehealth interventions targeting diabetes as a primary condition, and those that did not specifically recruit minority groups will be included. Search strategies were devised for indexed and keyword terms capturing type 2 diabetes, telehealth/health technology, and RCTs in English language publications from 2000 to July 2015 in MEDLINE, PsycINFO, EMBASE, CINAHL, and CENTRAL. Reference lists of included studies will also be searched. Two reviewers will independently screen abstracts and full-text articles against inclusion criteria, mediated by a third reviewer if consensus cannot be reached. Data extracted from included studies will be checked by a second reviewer and will be summarized using narrative synthesis. Results This research is in progress, with findings expected by Spring 2016. Conclusions This review will address research reporting and recruitment practices of ethnic minorities in telehealth RCTs for type 2

  20. A Randomised Controlled Trial to Reduce Sedentary Time in Young Adults at Risk of Type 2 Diabetes Mellitus: Project STAND (Sedentary Time ANd Diabetes)

    PubMed Central

    Biddle, Stuart J. H.; Edwardson, Charlotte L.; Wilmot, Emma G.; Yates, Thomas; Gorely, Trish; Bodicoat, Danielle H.; Ashra, Nuzhat; Khunti, Kamlesh; Nimmo, Myra A.; Davies, Melanie J.

    2015-01-01

    Aims Type 2 diabetes mellitus (T2DM), a serious and prevalent chronic disease, is traditionally associated with older age. However, due to the rising rates of obesity and sedentary lifestyles, it is increasingly being diagnosed in the younger population. Sedentary (sitting) behaviour has been shown to be associated with greater risk of cardio-metabolic health outcomes, including T2DM. Little is known about effective interventions to reduce sedentary behaviour in younger adults at risk of T2DM. We aimed to investigate, through a randomised controlled trial (RCT) design, whether a group-based structured education workshop focused on sitting reduction, with self-monitoring, reduced sitting time. Methods Adults aged 18–40 years who were either overweight (with an additional risk factor for T2DM) or obese were recruited for the Sedentary Time ANd Diabetes (STAND) RCT. The intervention programme comprised of a 3-hour group-based structured education workshop, use of a self-monitoring tool, and follow-up motivational phone call. Data were collected at three time points: baseline, 3 and 12 months after baseline. The primary outcome measure was accelerometer-assessed sedentary behaviour after 12 months. Secondary outcomes included other objective (activPAL) and self-reported measures of sedentary behaviour and physical activity, and biochemical, anthropometric, and psycho-social variables. Results 187 individuals (69% female; mean age 33 years; mean BMI 35 kg/m2) were randomised to intervention and control groups. 12 month data, when analysed using intention-to-treat analysis (ITT) and per-protocol analyses, showed no significant difference in the primary outcome variable, nor in the majority of the secondary outcome measures. Conclusions A structured education intervention designed to reduce sitting in young adults at risk of T2DM was not successful in changing behaviour at 12 months. Lack of change may be due to the brief nature of such an intervention and lack of focus

  1. Effect of aliskiren on post-discharge outcomes among diabetic and non-diabetic patients hospitalized for heart failure: insights from the ASTRONAUT trial

    PubMed Central

    Maggioni, Aldo P.; Greene, Stephen J.; Fonarow, Gregg C.; Böhm, Michael; Zannad, Faiez; Solomon, Scott D.; Lewis, Eldrin F.; Baschiera, Fabio; Hua, Tsushung A.; Gimpelewicz, Claudio R.; Lesogor, Anastasia; Gheorghiade, Mihai; Ramos, Silvina; Luna, Alejandra; Miriuka, Santiago; Diez, Mirta; Perna, Eduardo; Luquez, Hugo; Pinna, Jorge Garcia; Castagnino, Jorge; Alvarenga, Pablo; Ibañez, Julio; Blumberg, Eduardo Salmon; Dizeo, Claudio; Guerrero, Rodolfo Ahuad; Schygiel, Pablo; Milesi, Rodolfo; Sosa, Carlos; Hominal, Miguel; Marquez, Lilia Lobo; Poy, Carlos; Hasbani, Eduardo; Vico, Marisa; Fernandez, Alberto; Vita, Nestor; Vanhaecke, Johan; De Keulenaer, Gilles; Striekwold, Harry; Vervoort, Geert; Vrolix, Mathias; Henry, Philippe; Dendale, Paul; Smolders, Walter; Marechal, Patrick; Vandekerckhove, Hans; Oliveira, Mucio; Neuenschwande, Fernando; Reis, Gilmar; Saraiva, Jose; Bodanese, Luiz; Canesin, Manoel; Greco, Oswaldo; Bassan, Roberto; Marino, Roberto Luis; Giannetti, Nadia; Moe, Gordon; Sussex, Bruce; Sheppard, Richard; Huynh, Thao; Stewart, Robert; Haddad, Haissam; Echeverria, Luis; Quintero, Adalberto; Torres, Adriana; Jaramillo, Mónica; Lopez, Mónica; Mendoza, Fernan; Florez, Noel; Cotes, Carlos; Garcia, Magali; Belohlavek, Jan; Hradec, Jaromir; Peterka, Martin; Gregor, Pavel; Monhart, Zdenek; Jansky, Petr; Kettner, Jiri; Reichert, Petr; Spinar, Jindrich; Brabec, Tomas; Hutyra, Martin; Solar, Miroslav; Pietilä, Mikko; Nyman, Kai; Pajari, Risto; Cohen, Ariel; Galinier, Michel; Gosse, Philippe; Livarek, Bernard; Neuder, Yannick; Jourdain, Patrick; Picard, François; Isnard, Richard; Hoppe, Uta; Kaeaeb, Stefan; Rosocha, Stefan; Prondzinsky, Roland; Felix, Stephan; Duengen, Hans-Dirk; Figulla, Hans-Reiner; Fischer, Sven; Behrens, Steffen; Stawowy, Philipp; Kruells-Muench, Juergen; Knebel, Fabian; Nienaber, Christoph; Werner, Dierk; Aron, Wilma; Remppis, Bjoern; Hambrecht, Rainer; Kisters, Klaus; Werner, Nikos; Hoffmann, Stefan; Rossol, Siegbert; Geiss, Ernst; Graf, Kristof; Hamann, Frank; von Scheidt, Wolfgang; Schwinger, Robert; Tebbe, Ulrich; Costard-Jaeckle, Angelika; Lueders, Stephan; Heitzer, Thomas; Leutermann-Oei, Marie-Louise; Braun-Dullaeus, Ruediger; Roehnisch, Jens-Uwe; Muth, Gerhard; Goette, Andreas; Rotter, Achim; Ebelt, Henning; Olbrich, Hans-Georg; Mitrovic, Veselin; Hengstenberg, Christian; Schellong, Sebastian; Zamolyi, Karoly; Vertes, Andras; Matoltsy, Andras; Palinkas, Attila; Herczeg, Bela; Apro, Dezso; Lupkovics, Geza; Tomcsanyi, Janos; Toth, Kalman; Mathur, Atul; Banker, Darshan; Bharani, Anil; Arneja, Jaspal; Khan, Aziz; Gadkari, Milind; Hiremath, Jagdish; Patki, Nitin; Kumbla, Makund; Santosh, M.J.; Ravikishore, A.G.; Abhaichand, Rajpal; Maniyal, Vijayakukmar; Nanjappa, Manjunath; Reddy, P. Naveen; Chockalingam, Kulasekaran; Premchand, Rajendra; Mahajan, Vijay; Lewis, Basil; Wexler, Dov; Shochat, Michael; Keren, Andre; Omary, Muhamad; Katz, Amos; Marmor, Alon; Lembo, Giuseppe; Di Somma, Salvatore; Boccanelli, Alessandro; Barbiero, Mario; Pajes, Giuseppe; De Servi, Stefano; Greco, Dott Cosimo; De Santis, Fernando; Floresta, Agata; Visconti, Luigi Oltrona; Piovaccari, Giancarlo; Cavallini, Claudio; Di Biase, Matteo; Masini, Dott Franco; Vassanelli, Corrado; Viecca, Maurizio; Cangemi, Dott Francesco; Pirelli, Salvatore; Borghi, Claudio; Volpe, Massimo; Branzi, Angelo; Percoco, Dott Giovanni; Severi, Silvia; Santini, Alberto; De Lorenzi, Ettore; Metra, Marco; Zacà, Valerio; Mortara, Andrea; Tranquilino, Francisco P.; Babilonia, Noe A.; Ferrolino, Arthur M.; Manlutac, Benjamin; Dluzniewski, Miroslaw; Dzielinska, Zofia; Nowalany-Kozie, Ewa; Mazurek, Walentyna; Wierzchowiecki, Jerzy; Wysokinski, Andrzej; Szachniewicz, Joanna; Romanowski, Witold; Krauze-Wielicka, Magdalena; Jankowski, Piotr; Berkowski, Piotr; Szelemej, Roman; Kleinrok, Andrzej; Kornacewicz-Jac, Zdzislawa; Vintila, Marius; Vladoianu, Mircea; Militaru, Constantin; Dan, Gheorghe; Dorobantu, Maria; Dragulescu, Stefan; Kostenko, Victor; Vishnevsky, Alexandr; Goloschekin, Boris; Tyrenko, Vadim; Gordienko, Alexander; Kislyak, Oxana; Martsevich, Sergey; Kuchmin, Alexey; Karpov, Yurii; Fomin, Igor; Shvarts, Yury; Orlikova, Olga; Ershova, Olga; Berkovich, Olga; Sitnikova, Maria; Pakhomova, Inna; Boldueva, Svetlana; Tyurina, Tatiana; Simanenkov, Vladimir; Boyarkin, Mikhail; Novikova, Nina; Tereschenko, Sergey; Zadionchenko, Vladimir; Shogenov, Zaur; Gordeev, Ivan; Moiseev, Valentin; Wong, Raymond; Ong, Hean Yee; Le Tan, Ju; Goncalvesova, Eva; Kovar, Frantisek; Skalina, Ivan; Kasperova, Viera; Hojerova, Silvia

    2013-01-01

    Aims The objective of the Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT) was to determine whether aliskiren, a direct renin inhibitor, would improve post-discharge outcomes in patients with hospitalization for heart failure (HHF) with reduced ejection fraction. Pre-specified subgroup analyses suggested potential heterogeneity in post-discharge outcomes with aliskiren in patients with and without baseline diabetes mellitus (DM). Methods and results ASTRONAUT included 953 patients without DM (aliskiren 489; placebo 464) and 662 patients with DM (aliskiren 319; placebo 343) (as reported by study investigators). Study endpoints included the first occurrence of cardiovascular death or HHF within 6 and 12 months, all-cause death within 6 and 12 months, and change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 1, 6, and 12 months. Data regarding risk of hyperkalaemia, renal impairment, and hypotension, and changes in additional serum biomarkers were collected. The effect of aliskiren on cardiovascular death or HHF within 6 months (primary endpoint) did not significantly differ by baseline DM status (P = 0.08 for interaction), but reached statistical significance at 12 months (non-DM: HR: 0.80, 95% CI: 0.64–0.99; DM: HR: 1.16, 95% CI: 0.91–1.47; P = 0.03 for interaction). Risk of 12-month all-cause death with aliskiren significantly differed by the presence of baseline DM (non-DM: HR: 0.69, 95% CI: 0.50–0.94; DM: HR: 1.64, 95% CI: 1.15–2.33; P < 0.01 for interaction). Among non-diabetics, aliskiren significantly reduced NT-proBNP through 6 months and plasma troponin I and aldosterone through 12 months, as compared to placebo. Among diabetic patients, aliskiren reduced plasma troponin I and aldosterone relative to placebo through 1 month only. There was a trend towards differing risk of post-baseline potassium ≥6 mmol/L with aliskiren by underlying DM status (non-DM: HR: 1.17, 95% CI: 0.71–1.93; DM: HR: 2.39, 95% CI: 1.30

  2. Diabetes

    MedlinePlus

    ... to develop type 2 diabetes later in life. Polycystic ovary syndrome Polycystic ovary syndrome (PCOS) is a condition that occurs when an imbalance ... to form on the ovaries. Women who have PCOS are at an increased risk of developing type ...

  3. Horizon 2020 in Diabetic Kidney Disease: The Clinical Trial Pipeline for Add-On Therapies on Top of Renin Angiotensin System Blockade

    PubMed Central

    Perez-Gomez, Maria Vanessa; Sanchez-Niño, Maria Dolores; Sanz, Ana Belen; Martín-Cleary, Catalina; Ruiz-Ortega, Marta; Egido, Jesus; Navarro-González, Juan F.; Ortiz, Alberto; Fernandez-Fernandez, Beatriz

    2015-01-01

    Diabetic kidney disease is the most frequent cause of end-stage renal disease. This implies failure of current therapeutic approaches based on renin-angiotensin system (RAS) blockade. Recent phase 3 clinical trials of paricalcitol in early diabetic kidney disease and bardoxolone methyl in advanced diabetic kidney disease failed to meet the primary endpoint or terminated on safety concerns, respectively. However, various novel strategies are undergoing phase 2 and 3 randomized controlled trials targeting inflammation, fibrosis and signaling pathways. Among agents currently undergoing trials that may modify the clinical practice on top of RAS blockade in a 5-year horizon, anti-inflammatory agents currently hold the most promise while anti-fibrotic agents have so far disappointed. Pentoxifylline, an anti-inflammatory agent already in clinical use, was recently reported to delay estimated glomerular filtration rate (eGFR) loss in chronic kidney disease (CKD) stage 3–4 diabetic kidney disease when associated with RAS blockade and promising phase 2 data are available for the pentoxifylline derivative CTP-499. Among agents targeting chemokines or chemokine receptors, the oral small molecule C-C chemokine receptor type 2 (CCR2) inhibitor CCX140 decreased albuminuria and eGFR loss in phase 2 trials. A dose-finding trial of the anti-IL-1β antibody gevokizumab in diabetic kidney disease will start in 2015. However, clinical development is most advanced for the endothelin receptor A blocker atrasentan, which is undergoing a phase 3 trial with a primary outcome of preserving eGFR. The potential for success of these approaches and other pipeline agents is discussed in detail. PMID:26239562

  4. Prevention of diabetes in hypertensive patients: Results and implications from the VALUE trial

    PubMed Central

    Zhou, Ming-Sheng; Schulman, Ivonne Hernandez

    2009-01-01

    A growing number of experimental and clinical studies have provided evidence indicating that pharmacological blockade of the renin–angiotensin system (RAS) by either angiotensin-converting enzyme inhibitors or angiotensin type 1 receptor blockers reduces the incidence of new onset type 2 diabetes in subjects with hypertension and/or cardiovascular disease, independently of antihypertensive and cardiovascular protective effects. The beneficial effects of RAS inhibition on the development of diabetes have been largely attributed to improvements in peripheral insulin sensitivity and glucose metabolism. This review focuses on recent experimental and clinical evidence supporting the role of RAS inhibition in the reduction of new onset type 2 diabetes and the mechanisms that may be involved. PMID:19475773

  5. Improvement in medication adherence and self-management of diabetes with a clinical pharmacy program: a randomized controlled trial in patients with type 2 diabetes undergoing insulin therapy at a teaching hospital

    PubMed Central

    Cani, Catarina Gomes; da Silva Girão Lopes, Laura; Queiroz, Márcia; Nery, Márcia

    2015-01-01

    OBJECTIVE: To evaluate the impact of a clinical pharmacy program on health outcomes in patients with type 2 diabetes undergoing insulin therapy at a teaching hospital in Brazil. METHOD: A randomized controlled trial with a 6-month follow-up period was performed in 70 adults, aged 45 years or older, with type 2 diabetes who were taking insulin and who had an HbA1c level ≥8%. Patients in the control group (CG) (n = 36) received standard care, patients in the intervention group (IG) (n = 34) received an individualized pharmacotherapeutic care plan and diabetes education. The primary outcome measure was change in HbA1c. Secondary outcomes included diabetes and medication knowledge, adherence to medication, insulin injection and home blood glucose monitoring techniques and diabetes-related quality of life. Outcomes were evaluated at baseline and 6 months using questionnaires. RESULTS: Diabetes knowledge, medication knowledge, adherence to medication and correct insulin injection and home blood glucose monitoring techniques significantly improved in the intervention group but remained unchanged in the control group. At the end of the study, mean HbA1c values in the control group remained unchanged but were significantly reduced in the intervention group. Diabetes-related quality of life significantly improved in the intervention group but worsened significantly in the control group. CONCLUSION: The program improved health outcomes and resulted in better glycemic control in patients with type 2 diabetes undergoing insulin therapy. PMID:25789518

  6. Partial meal replacement plan and quality of the diet at one year: Action for Health in Diabetes (Look AHEAD) Trial

    PubMed Central

    Raynor, Hollie A.; Anderson, Andrea M.; Miller, Gary D.; Reeves, Rebecca; Delahanty, Linda M.; Vitolins, Mara Z.; Harper, Patricia; Mobley, Connie; Konersman, Kati; Mayer-Davis, Elizabeth

    2014-01-01

    Background Little is known about diet quality with a reduced-energy, low-fat, partial meal replacement (PMR) plan, especially in individuals with type 2 diabetes. The Action for Health in Diabetes (Look AHEAD) trial implemented a PMR plan in the intensive lifestyle intervention (ILI). Objective Compare dietary intake and percent meeting fat-related and food group dietary recommendations in ILI and diabetes support and education (DSE) groups at 12 months. Design Randomized controlled trial, comparing ILI to DSE, at 0- and 12-months. Participants/setting From 16 United States sites, the first 50% of participants (aged 45 to 76 years, overweight or obese, with type 2 diabetes) were invited to complete dietary assessments. Complete 0- and 12-month dietary assessments (collected between 2001 and 2004) were available on 2,397 participants (46.6% of total participants), with 1,186 randomized to DSE and 1,211 randomized to ILI. Main outcome measures A food frequency questionnaire assessed intake: energy; percent energy from protein, fat, carbohydrate, polyunsaturated fatty acids (PUFA), and saturated fats; trans fatty acids; cholesterol; fiber; weekly meal replacements (MRs); and daily servings from food groups from the Food Guide Pyramid. Statistical analyses performed Mixed-factor analyses of covariance (ANCOVA), using Proc MIXED with a repeated statement, with age, sex, race/ethnicity, education, and income controlled. Unadjusted chi-square tests compared percent meeting fat-related and food group recommendations at 12 months. Results At 12 months, ILI had a significantly lower fat and cholesterol intake and greater fiber intake than DSE. ILI consumed more servings/day of fruits; vegetables; and milk, yogurt & cheese; and fewer servings/day of fats, oils & sweets than DSE. A greater percentage of ILI than DSE participants met fat-related and most food group recommendations. Within ILI, a greater percentage of participants consuming ≥ 2 MRs/day than < 1 MR/day met most

  7. Transcatheter versus Surgical Aortic Valve Replacement in Patients with Diabetes and Severe Aortic Stenosis at High Risk for Surgery: An Analysis of the PARTNER Trial

    PubMed Central

    Lindman, Brian R.; Pibarot, Philippe; Arnold, Suzanne V.; Suri, Rakesh; McAndrew, Thomas C.; Maniar, Hersh S.; Zajarias, Alan; Kodali, Susheel; Kirtane, Ajay J.; Thourani, Vinod H.; Tuzcu, E. Murat; Svensson, Lars G.; Waksman, Ron; Smith, Craig R.; Leon, Martin B.

    2013-01-01

    Objectives To determine whether a less invasive approach to aortic valve replacement (AVR) improves clinical outcomes in diabetic patients with aortic stenosis (AS). Background Diabetes is associated with increased morbidity and mortality after surgical AVR for AS. Methods Among treated patients with severe symptomatic AS at high-risk for surgery in the PARTNER trial, we examined outcomes stratified by diabetes status of patients randomly assigned to transcatheter or surgical AVR. The primary outcome was all-cause mortality at 1 year. Results Among 657 patients enrolled in PARTNER who underwent treatment, there were 275 patients with diabetes (145 transcatheter, 130 surgical). There was a significant interaction between diabetes and treatment group for 1-year all-cause mortality (p=0.048). Among diabetic patients, all-cause mortality at 1 year was 18.0% in the transcatheter group and 27.4% in the surgical group (HR 0.60; 95% CI, 0.36–0.99; p=0.04). Results were consistent among patients treated via transfemoral or transapical routes. In contrast, among non-diabetic patients, there was no significant difference in all-cause mortality at 1 year (p=0.48). Among diabetic patients, the 1-year rates of stroke were similar between treatment groups (3.5% transcatheter vs. 3.5% surgery, p=0.88), but the rates of renal failure requiring dialysis >30 days were lower in the transcatheter group (0% vs. 6.1%, p=0.003). Conclusions Among patients with diabetes and severe symptomatic AS at high-risk for surgery, this post-hoc stratified analysis of the PARTNER trial suggests there is a survival benefit, no increase in stroke, and less renal failure from treatment with transcatheter compared to surgical AVR. PMID:24291272

  8. The Schoen Affair

    NASA Astrophysics Data System (ADS)

    Reich, Eugenie Samuel

    2010-03-01

    The Schoen Affair was a series of groundbreaking fraudulent claims in the fields of organic, plastic and molecular electronics. The Affair was exposed in 2002 and perpetrated by Jan Hendrik Schoen, a researcher at Bell Laboratories in New Jersey. In this talk, I draw on interviews with 125 scientists, emails by Schoen and colleagues, reviews of the fraudulent papers, and analyses of the fake data to illuminate Schoen's motive and modus operandi. I focus particularly on how Schoen first began to fake data as a graduate student, and how he progressed to make fraudulent claims that appeared plausible to managers at Bell Labs and other colleagues. I also describe how his claims were handled by the journals, mostly with respect to the actions of editors and reviewers at the journals Nature and Science.

  9. An Innovative Multiphased Strategy to Recruit Underserved Adults into a Randomized Trial of a Community-Based Diabetes Risk Reduction Program

    ERIC Educational Resources Information Center

    Santoyo-Olsson, Jasmine; Cabrera, Julissa; Freyre, Rachel; Grossman, Melanie; Alvarez, Natalie; Mathur, Deepika; Guerrero, Maria; Delgadillo, Adriana T.; Kanaya, Alka M.; Stewart, Anita L.

    2011-01-01

    Purpose: To conduct and evaluate a two-phased community-based approach to recruit lower socioeconomic status, minority, or Spanish-speaking adults at risk of developing diabetes to a randomized trial of a lifestyle intervention program delivered by a public health department. Design: Within geographic areas comprising our target population, 4…

  10. Assessing social determinants of health in a pediatric diabetes clinical research trial: Are recruited subjects representative of the larger clinical population?

    PubMed

    Inman, Mark; Daneman, Denis; Curtis, Jacqueline; Sochett, Etienne; Elia, Yesmino; Dunger, David B; Deanfield, John; Mahmud, Farid H

    2016-03-01

    Social determinants of health (SDH) impact clinical outcomes and are often poorly described in research trials. Using a validated tool, SDH dimensions were compared between adolescents enrolled and not enrolled into a large diabetes study. We observed that our study cohort reflected a SDH profile mirroring the eligible population. PMID:26972960

  11. Intensive lifestyle intervention reduces urinary incontinence in overweight/obese men with Type 2 diabetes: Results from the look AHEAD trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Purpose: We determined the effect of an intensive lifestyle intervention on the prevalence, incidence and resolution of bothersome nocturia, increased daytime urinary voiding and urinary incontinence in overweight/obese men with type 2 diabetes after 1 year in the Look AHEAD trial. Materials and Me...

  12. Reduction in weight and cardiovascular diasease risk factors in individuals with type 2 diabetes: One-year results of the Look AHEAD trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The effectiveness of intentional weight loss in reducing cardiovascular disease (CVD) events in type 2 diabetes is unknown. This report describes 1-year changes in CVD risk factors in a trial designed to examine the long-term effects of an intensive lifestyle intervention on the incidence of major C...

  13. Retinopathy in youth with type 2 diabetes participating in the TODAY clinical trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The objective of this study was to determine the prevalence of retinopathy in 517 youth with type 2 diabetes of 2–8 years duration enrolled in the TODAY study. Retinal photographs were graded centrally for retinopathy using established standards. Retinopathy was identified in 13.7% of subjects. Prev...

  14. Data on carotid intima-media thickness and lipoprotein subclasses in type 1 diabetes from the Diabetes Control and Complications Trial and the Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC)

    PubMed Central

    Basu, Arpita; Jenkins, Alicia J.; Zhang, Ying; Stoner, Julie A.; Klein, Richard L.; Lopes-Virella, Maria F.; Timothy Garvey, W.; Lyons, Timothy J.

    2015-01-01

    Type 1 diabetes (T1DM) is associated with increased risk of macrovascular complications. We examined longitudinal associations of serum conventional lipids and nuclear magnetic resonance (NMR)-determined lipoprotein subclasses with carotid intima-media thickness (IMT) in adults with T1DM (n=455) enrolled in the Diabetes Control and Complications Trial (DCCT). Data on serum lipids and lipoproteins were collected at DCCT baseline (1983–89) and were correlated with common and internal carotid IMT determined by ultrasonography during the observational follow-up of the DCCT, the Epidemiology of Diabetes Interventions and Complications (EDIC) study, at EDIC ‘Year 1’ (199–1996) and EDIC ‘Year 6’ (1998–2000). This article contains data on the associations of DCCT baseline lipoprotein profiles (NMR-based VLDL & chylomicrons, IDL/LDL and HDL subclasses and ‘conventional’ total, LDL-, HDL-, non-HDL-cholesterol and triglycerides) with carotid IMT at EDIC Years 1 and 6, stratified by gender. The data are supplemental to our original research article describing detailed associations of DCCT baseline lipids and lipoprotein profiles with EDIC Year 12 carotid IMT (Basu et al. in press) [1]. PMID:26759826

  15. Effects of Pistachio Nut Supplementation on Blood Glucose in Patients with Type 2 Diabetes: A Randomized Crossover Trial

    PubMed Central

    Parham, Mahmoud; Heidari, Saeide; Khorramirad, Ashraf; Hozoori, Mohammad; Hosseinzadeh, Fatemeh; Bakhtyari, Lida; Vafaeimanesh, Jamshid

    2014-01-01

    BACKGROUND: Diabetes is a chronic, potentially debilitating, and often fatal disease. Dietary strategies to reduce postprandial glycemia are important in the prevention and treatment of diabetes. Nuts are rich in mono- and polyunsaturated fatty acids, which may reduce hyperglycemia and improve metabolism. OBJECTIVES: To evaluate the effectiveness of pistachio nut supplementation on glycemic and inflammatory measures in patients with type 2 diabetes. METHODS: In this double-blind, randomized, placebo-controlled, crossover trial, 48 diabetic patients were equally assigned to groups A and B. Patients in group A received a snack of 25 g pistachio nuts twice a day for 12 weeks and group B received a control meal without nuts. After 12 weeks of intervention, the patients had an 8-week washout. Then the groups were displaced, and group B received the same amount of pistachios for 12 weeks. RESULTS: With respect to the total change in variables over both phases, there was a marked decrease in HbA1c (-0.4%) and fasting blood glucose (FBG) concentrations (-16 mg/dl) in the pistachio group compared with the control group (p ≤ 0.001 for both). There was no overall significant change in BMI, blood pressure, HOMA-IR, and C-reactive protein (CRP) concentrations. Analysis of the two phases separately showed a decrease in FBG by 14 mg/dl and in HbA1c by 0.45% in the treatment group (A) after 12 weeks, while no significant differences were seen in group B (control group). In the second phase, FBG decreased from 151.36 ± 39.22 to 137.28 ± 28.65 mg/dl (-14 mg/dl) and HbA1c decreased from 7.42 ± 0.97 to 7.15 ± 0.68 mg/dl (-0.28%, p = 0.013 and p = 0.033, respectively) in the pistachio group (B). Pistachio consumption reduced systolic blood pressure (p = 0.007), BMI (p = 0.011), and CRP (p = 0.002) in patients from the treatment groups, but not insulin resistance. CONCLUSIONS: Dietary consumption of pistachio nuts as a snack has beneficial effects on glycemic control, blood

  16. Internet-delivered cognitive behaviour therapy for depression in people with diabetes: study protocol for a randomised controlled trial

    PubMed Central

    Robins, Lisa; Newby, Jill; Wilhelm, Kay; Smith, Jessica; Fletcher, Therese; Ma, Trevor; Finch, Adam; Campbell, Lesley; Andrews, Gavin

    2015-01-01

    Introduction Depression substantially contributes to the personal burden and healthcare costs of living with diabetes mellitus (DM). Comorbid depression and DM are associated with poorer quality of life, poorer self-management and glycemic control, increased risk for DM complications and higher mortality rates, and higher health service utilization. Depression remains under-recognized and undertreated in people with DM, which may, in part, result from barriers associated with accessing face-to-face treatment. This study will examine the efficacy of an internet-based cognitive behaviour therapy programme for major depressive disorder (iCBT-MDD) in people with DM. Methods and analysis A CONSORT 2010 compliant, registered randomised controlled trial of the intervention (iCBT-MDD) versus a treatment as usual control group will be conducted. The study will include 100 adults aged 18 years and over with a diagnosis of type 1 or type 2 DM and self-reported symptoms that satisfy MDD which will enable us to detect a statistically significant difference with a group effect size of 0.6 at a power of 80% and significance level of p=0.05. Participants will be randomised to receive the iCBT-MDD programme immediately, or to wait 10 weeks before accessing the programme. Primary outcomes will be self-reported depression severity, DM-related distress, and glycemic control (glycosylated hemoglobin). Secondary outcomes will be general distress and disability, generalized anxiety, lifestyle behaviours, somatization, eating habits, alcohol use, and acceptability of the iCBT programme to participants, and practicality for clinicians. Data will be analyzed with linear mixed models for each outcome measure. Ethics and dissemination The Human Research Ethics Committee of St Vincent's Hospital Australia have given ethics approval (HREC/13/SVH/291). Results will be disseminated via peer-reviewed publication and social media channels of Australian Diabetes Consumer Representative Bodies

  17. Benefits of Fixed Dose Combination of Ramipril/Amlodipine in Hypertensive Diabetic Patients: A Subgroup Analysis of RAMONA Trial

    PubMed Central

    Simonyi, Gabor

    2016-01-01

    Background: Combination of angiotensin-converting enzyme inhibitors and calcium channel blockers has been successfully used in the antihypertensive therapy for many years. Fixed dose combinations of ramipril/amlodipine have a benefit effect for patients to achieve target blood pressure (BP). This study aimed to assess the efficacy and safety of fixed dose combinations of ramipril and amlodipine (Egiramlon®) in hypertensive diabetic patients. Methods: Hypertensive diabetic patients who were enrolled into the RAMONA trial were included in this open, prospective, Phase IV observational clinical study. Patients had mild-to-moderate hypertension and failed to reach target BP levels through their previous therapy. During the four months of observation, patients took part in three visits (1st day = visit 1, 1st month = visit 2, and 4th month = visit 3) where they received a fixed dose combination of 5/5, 5/10, 10/5, or 10/10 mg ramipril/amlodipine, respectively, with the possibly required dose titrations, based on the decision of their attending physician. Target BP for diabetic patients was <140/85 mmHg. BP levels were measured in all visits, by taking two readings at 2-min interval. Laboratory tests including full blood count, renal function test, electrolytes, blood glucose, serum cholesterol, uric acid, triglycerides, liver function test, creatinine kinase, and midstream urinalysis were performed at visit 1 and visit 3. Results: The 6423 patients completed the study. Among these patients, 1276 (19.9%) patients suffered from type 2 diabetes mellitus. The mean age of these diabetic patients was 64.2 ± 10.0 years; 707 (55.4%) patients were males. Target BP was achieved by 891 (69.8%) of diabetic patients at visit 3 (primary endpoint). BP decreased from 157.5/91.3 ± 9.6/7.6 mmHg (visit 1) to 130.9/79.6 ± 7.4/5.8 mmHg (visit 3). As for the secondary endpoint of the study, total cholesterol decreased from 5.50 ± 1.13 mmol/L (visit 1) to 5.20 ± 0.95 mmol/L (P = 0

  18. A clinical trial testing the efficacy of PDT in preventing amputation in diabetic patients.

    PubMed

    Tardivo, João Paulo; Adami, Fernando; Correa, João Antonio; Pinhal, Maria Aparecida S; Baptista, Mauricio S

    2014-09-01

    The feet of diabetic patients continue to be an unsolved problem in medicine. Uncontrolled neuropathy, ulceration and infection usually lead to amputation and presently there is no effective and reliable method that can be used to provide an efficient cure. Overall improvement in the salvage strategies, based on comprehensive pre-clinical evaluation, debridement, antibiotic therapy and follow up, has shown improvements in certain hospital settings, but the general picture for patients with diabetic foot is to have some sort of amputation, especially in underserved populations. It is clearly necessary to develop novel treatment strategies for this worldwide health problem. Photodynamic therapy (PDT) is a treatment modality that uses light to generate in situ reactive oxygen species, which can cause cell death. PDT can be used to treat several diseases, including foot infections that do not respond well to antibiotic therapy. There are several characteristics of PDT that make it potentially ideal to treat diabetic feet: the photosensitizer is non-toxic in the dark, but after illumination it becomes a very efficient antimicrobial agent with topical use, and it can regenerate small bones, such as the phalanges. However, PDT is still not used in clinical practice to treat diabetic feet. Therefore, we decided to perform a clinical study to prove that PDT is an effective method to avoid amputation of infected diabetic feet. An inexpensive PDT protocol was developed and applied to 18 patients with osteomyelitis, classified as Grade 3 on the Wagner scale. Only one of these patients suffered amputation. At least two of them were cured from resistant bacteria strains without intravenous antibiotic therapy. In the control group of 16 patients, all of them ended up suffering amputation. The rate of amputation in the PDT group was 0.029 times the rate in the control group and the difference is clearly statistically significant (p=0.002). PMID:24814697

  19. Therapeutic effects of Citrullus colocynthis fruit in patients with type II diabetes: A clinical trial study

    PubMed Central

    Barghamdi, Batol; Ghorat, Fereshteh; Asadollahi, Khairollah; Sayehmiri, Kourosh; Peyghambari, Robab; Abangah, Ghobad

    2016-01-01

    Aim: Citrullus colocynthis plant was traditionally used for the treatment of diabetes in Sabzevar city, Iran. This study aimed to investigate the effects of C. colocythis on fasting blood sugar (FBS) and HbA1c in patients with type II diabetes. Materials and Methods: Totally 70 patients with type II diabetes attending the diabetes clinic in Sabzevar city were investigated. Patients were divided into two groups of intervention and placebo randomly and were studied for 2 months. Mean serum level of FBS and HbA1c was compared within and between groups at the end of the study. Data were analyzed using student and paired t-tests via SPSS software version 16. Results: A significant difference was revealed between before and after intervention for HbA1c and FBS levels in the intervention group (P = 0.01 and P = 0.04, respectively). The difference between before and after intervention for FBS and HbA1c levels in the placebo group were not significant (P = 0.8, P = 0.68 respectively). This study showed a negative relationship between either the mean ± standard deviation serum level of FBS or HbA1c and body mass index in the treatment group significantly (P = 0.03, 0.008, respectively). The present study did not identify any side effects during the study period among the treatment group. Conclusion: According to the findings of this study, application of 125 mg C. colocynthis once per day for 2 months can lead to considerable decrease in the mean levels of HbA1c and FBS among the patients with type II diabetes without any side effects. PMID:27134465

  20. Educating Resident Physicians Using Virtual Case-Based Simulation Improves Diabetes Management: A Randomized Controlled Trial

    PubMed Central

    Sperl-Hillen, JoAnn; O’Connor, Patrick J.; Ekstrom, Heidi L.; Rush, William A.; Asche, Stephen E.; Fernandes, Omar D.; Apana, Deepika; Amundson, Gerald H.; Johnson, Paul E.; Curran, Debra M.

    2014-01-01

    Purpose To test a virtual case-based Simulated Diabetes Education (SimDE) intervention developed to teach primary care residents how to manage diabetes. Method Nineteen primary care residency programs, with 341 volunteer residents in all post-graduate years (PGY), were randomly assigned to a SimDE intervention group or control group (CG). The web-based interactive educational intervention used computerized virtual patients who responded to provider actions through programmed simulation models. Eighteen distinct learning cases (L-cases) were assigned to SimDE residents over 6 months from 2010–2011. Impact was assessed using performance on 4 virtual assessment cases (A-cases), an objective knowledge test, and pre-post changes in self-assessed diabetes knowledge and confidence. Group comparisons were analyzed using generalized linear mixed models, controlling for clustering of residents within residency programs and differences in baseline knowledge. Results The percentage of residents appropriately achieving A-case composite clinical goals for glucose, blood pressure, and lipids was: A-Case 1, SimDE = 21.2%, CG = 1.8%, P = .002; A-Case 2, SimDE = 15.7%, CG = 4.7%, P = .02; A-Case 3, SimDE = 48.0%, CG = 10.4%, P < .001; A-Case 4, SimDE = 42.1%, CG = 18.7%, P = .004. The mean knowledge score and pre-post changes in self-assessed knowledge and confidence were significantly better for SimDE group than CG participants. Conclusions A virtual case-based simulated diabetes education intervention improved diabetes management skills, knowledge, and confidence for primary care residents. PMID:25006707

  1. In Silico Preclinical Trials: A Proof of Concept in Closed-Loop Control of Type 1 Diabetes

    PubMed Central

    Kovatchev, Boris P.; Breton, Marc; Man, Chiara Dalla; Cobelli, Claudio

    2009-01-01

    Arguably, a minimally invasive system using subcutaneous (s.c.) continuous glucose monitoring (CGM) and s.c. insulin delivery via insulin pump would be a most feasible step to closed-loop control in type 1 diabetes mellitus (T1DM). Consequently, diabetes technology is focusing on developing an artificial pancreas using control algorithms to link CGM with s.c. insulin delivery. The future development of the artificial pancreas will be greatly accelerated by employing mathematical modeling and computer simulation. Realistic computer simulation is capable of providing invaluable information about the safety and the limitations of closed-loop control algorithms, guiding clinical studies, and out-ruling ineffective control scenarios in a cost-effective manner. Thus computer simulation testing of closed-loop control algorithms is regarded as a prerequisite to clinical trials of the artificial pancreas. In this paper, we present a system for in silico testing of control algorithms that has three principal components: (1) a large cohort of n = 300 simulated “subjects” (n = 100 adults, 100 adolescents, and 100 children) based on real individuals' data and spanning the observed variability of key metabolic parameters in the general population of people with T1DM; (2) a simulator of CGM sensor errors representative of Freestyle Navigator™, Guardian RT, or Dexcom™ STS™, 7-day sensor; and (3) a simulator of discrete s.c. insulin delivery via OmniPod Insulin Management System or Deltec Cozmo® insulin pump. The system has been shown to represent adequate glucose fluctuations in T1DM observed during meal challenges, and has been accepted by the Food and Drug Administration as a substitute to animal trials in the preclinical testing of closed-loop control strategies. PMID:19444330

  2. Effects of Minocycline on Urine Albumin, Interleukin-6, and Osteoprotegerin in Patients with Diabetic Nephropathy: A Randomized Controlled Pilot Trial

    PubMed Central

    Wang, Ying; Tong, Lili; Pak, Youngju; Andalibi, Ali; LaPage, Janine A.; Adler, Sharon G.

    2016-01-01

    Background We tested minocycline as an anti-proteinuric adjunct to renin-angiotensin-aldosterone system inhibitors (RAASi) in diabetic nephropathy (DN) and measured urinary biomarkers to evaluate minocycline’s biological effects. Methods Design: Prospective, single center, randomized, placebo-controlled, intention-to-treat pilot trial. Inclusion. Type 2 diabetes/DN; Baseline creatinine clearance > 30 mL/min; proteinuria ≥ 1.0 g/day; Age ≥30 years; BP <150/95 mm Hg; intolerant of/at maximum RAASi dose. Protocol. 3-wk screening; Baseline randomization; Urine and blood measures at months 1, 2, 4, and Month 6 study completion. Urine interleukin-6 (IL-6) and osteoprotegerin were measured in a subset. Primary outcome. Natural log of urine protein/creatinine (ln U P:Cr) ratio at Month 6 vs Baseline. Results 30 patients completed the study. The 15% decline in U P: Cr in minocycline patients (6 month P:Cr ÷ Baseline P:Cr, 0.85 vs. 0.92) was not significant (p = 0.27). Creatinine clearance did not differ in the 2 groups. Urine IL-6:Cr (p = 0.03) and osteoprotegerin/Cr (p = 0.046) decrements were significant. Minocycline modified the relationship between urine IL-6 and proteinuria, suggesting a protective biological effect. Conclusions Although the decline in U P:Cr in minocycline patients was not statistically significant, the significant differences in urine IL-6 and osteoprotegerin suggest that minocycline may confer cytoprotection in patients with DN, providing a rationale for further study. Trial Registration Clinicaltrials.gov NCT01779089 PMID:27019421

  3. A Randomized Trial of Peribulbar Triamcinolone Acetonide with and without Focal Photocoagulation for Mild Diabetic Macular Edema: A Pilot Study

    PubMed Central

    2008-01-01

    Objective To provide pilot data on the safety and efficacy of anterior and posterior subtenon's injections of triamcinolone either alone or in combination with focal photocoagulation in the treatment of mild diabetic macular edema (DME). Design Prospective phase 2 multi-center randomized clinical trial. Participants 109 patients (129 eyes) with mild diabetic macular edema and visual acuity 20/40 or better. Methods The participants were randomly assigned to receive either focal photocoagulation (N = 38), 20 mg anterior subtenon's injection of triamcinolone (N = 23), 20 mg anterior subtenon's injection followed by focal photocoagulation after 4 weeks (N = 25), 40 mg posterior subtenon's injection of triamcinolone (N = 21), or 40 mg posterior subtenon's injection followed by focal photocoagulation after 4 weeks (N = 22). Follow-up visits were performed at 4, 8, 17, and 34 weeks. Main Outcome Measures Change in visual acuity and retinal thickness measured with the Optical Coherence Tomography (OCT). Results At baseline, mean visual acuity in the study eyes was 20/25 and mean OCT central subfield thickness was 328 microns. Changes in retinal thickening and in visual acuity were not significantly different among the five groups at 34 weeks (P=0.46 and P=0.94, respectively). There was a suggestion of a greater proportion of eyes having a central subfield thickness < 250 microns at 17 weeks when the peribulbar triamcinolone was combined with focal photocoagulation. Elevated intraocular pressure and ptosis were adverse effects attributable to the injections. Conclusion In cases of DME with good visual acuity, peribulbar triamcinolone, with or without focal photocoagulation, is unlikely to be of substantial benefit. Based on these results, a phase 3 trial to evaluate the benefit of these treatments for mild DME is not warranted. PMID:17544778

  4. Effect of Sulodexide on Urinary Biomarkers of Kidney Injury in Normoalbuminuric Type 2 Diabetes: A Randomized Controlled Trial

    PubMed Central

    Satirapoj, Bancha; Kaewput, Wisit; Supasyndh, Ouppatham; Ruangkanchanasetr, Prajej

    2015-01-01

    Glycosaminoglycans or sulodexide has shown benefits in early experimental diabetic nephropathy (DN) models, but its efficacy in patients with early stage of DN is unknown. Methods. Twenty patients were randomly assigned to the placebo group and another 20 patients were randomly assigned to receive sulodexide 100 mg/day for 14 weeks. Primary outcome was a change of urinary TGF-beta1, albuminuria, and glomerular filtration rate (GFR). All patients had stable metabolic profiles for at least 90 days before randomization. Results. Urinary TGF-beta1 increased significantly in the placebo group but did not change significantly in the sulodexide group. Additionally, the mean change of urine TGF-beta1 in the placebo group was significantly higher than that in the sulodexide group (8.44 ± 9.21 versus 2.17 ± 6.96 pg/mg Cr, P = 0.02). Mean changes of urinary albumin were 15.05 ± 30.09 μg/mg Cr (P = 0.038) in the placebo group and 13.89 ± 32.25 μg/mg Cr (P = 0.069) in the sulodexide group. No consistent patterns of side effects were observed. Conclusion. In this 14-week trial, benefits of sulodexide in preventing the increase of urinary TGF-beta1 were observed in patients with normoalbuminuric type 2 diabetes. The study suggests that sulodexide treatment may provide additional renoprotection in early stage DN. This trial is registered with TCTR20140806001. PMID:25918727

  5. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes

    PubMed Central

    Mathiesen, Elisabeth R; Jovanovič, Lois; McCance, David R; Ivanisevic, Marina; Durán-Garcia, Santiago; Brøndsted, Lise; Nazeri, Avideh; Damm, Peter

    2014-01-01

    Objective This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented. Methods Subjects were randomized to IDet (n = 152) or NPH (n = 158) ≤12 months before pregnancy or at 8–12 gestational weeks. Results For IDet and NPH, there were 128 and 136 live births, 11 and 9 early fetal losses, and two and one perinatal deaths, respectively. Gestational age at delivery was greater for children from the IDet arm than the NPH arm (treatment difference: 0.49 weeks [95% CI 0.11;0.88], p = 0.012, linear regression). Sixteen children had a malformation (IDet: n = 8/142, 5.6%; NPH: n = 8/145, 5.5%). The incidence of adverse events was similar between treatments. Conclusion IDet is as well tolerated as NPH as regards perinatal outcomes in pregnant women with type 1 diabetes and no safety issues were identified. PMID:23617228

  6. Topical Administration of a Connexin43-based peptide Augments Healing of Chronic Neuropathic Diabetic Foot Ulcers: A Multicenter, Randomized Trial

    PubMed Central

    Grek, Christina L.; Prasad, G.M.; Viswanathan, Vijay; Armstrong, David G.; Gourdie, Robert G.; Ghatnekar, Gautam S.

    2015-01-01

    Nonhealing neuropathic foot ulcers remain a significant problem in individuals with diabetes. The gap-junctional protein connexin43 (Cx43) has roles in dermal wound healing and targeting Cx43 signaling accelerates wound reepithelialization. In a prospective, randomized, multi-center clinical trial we evaluated the efficacy and safety of a peptide mimetic of the C-terminus of Cx43, ACT1, in accelerating the healing of chronic diabetic foot ulcers (DFUs) when incorporated into standard of care protocols. Adults with DFUs of at least four weeks duration were randomized to receive standard of care with or without topical application of ACT1. Primary outcome was mean percent ulcer reepithelialization and safety variables included incidence of treatment related adverse events and detection of ACT1 immunogenicity. ACT1 treatment was associated with a significantly greater reduction in mean percent ulcer area from baseline to 12 weeks (72.1% vs. 57.1%; p = 0.03). Analysis of incidence and median time-to-complete-ulcer closure revealed that ACT1 treatment was associated with a greater percentage of participants that reached 100% ulcer reepitheliazation and a reduced median time-to-complete-ulcer closure. No adverse events reported were treatment related, and ACT1 was not immunogenic. Treatment protocols that incorporate ACT1 may present a therapeutic strategy that safely augments the reepithelialization of chronic DFUs. PMID:25703647

  7. Engaging South Asian women with type 2 diabetes in a culturally relevant exercise intervention: a randomized controlled trial

    PubMed Central

    Natesan, Alamelu; Nimbal, Vani C; Ivey, Susan L; Wang, Elsie J; Madsen, Kristine A; Palaniappan, Latha P

    2015-01-01

    Background We examined the efficacy of a culturally relevant exercise program in improving glycated hemoglobin (HbA1c) among South Asian women with type 2 diabetes, compared with usual care. Methods This was a randomized controlled 8-week pilot study of Bollywood dance among South Asian women with type 2 diabetes. The intervention consisted of 1 h Bollywood dance classes offered twice per week. The primary outcome was change in HbA1c. The effect of attendance on this outcome was also examined. Results The intervention group demonstrated a decrease in HbA1c from baseline (−0.18% (0.2%); p=0.018) compared with a non-significant increase in the usual care group (+0.03% (0.2%)); p value for difference between groups was 0.032. Participants attending at least 10 of 16 sessions had a statistically significant reduction in weight (−0.69 kg (0.76 kg)) compared with those attending fewer sessions (+0.86 kg (0.71 kg)). Conclusions These results support culturally relevant dance as a successful exercise intervention to promote HbA1c control, compared with usual care. Trial registration number NCT02061618. PMID:26566446

  8. Silymarin in Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Voroneanu, Luminita; Nistor, Ionut; Dumea, Raluca; Apetrii, Mugurel; Covic, Adrian

    2016-01-01

    Type 2 diabetes mellitus (T2DM) is associated with increased risk of cardiovascular disease and nephropathy—now the leading cause of end-stage renal disease and dialysis in Europe and the United States. Inflammation and oxidative stress play a pivotal role in the development of diabetic complications. Silymarin, an herbal drug with antioxidant and anti-inflammatory properties, may improve glycemic control and prevent the progression of the complications. In a systematic review and meta-analysis including five randomized controlled trials and 270 patients, routine silymarin administration determines a significant reduction in fasting blood glucose levels (−26.86 mg/dL; 95% CI −35.42–18.30) and HbA1c levels (−1.07; 95% CI −1.73–0.40) and has no effect on lipid profile. Benefits for silymarin on proteinuria and CKD progressions are reported in only one small study and are uncertain. However, being aware of the low quality of the available evidence and elevated heterogeneity of these studies, no recommendation can be made and further studies are needed. PMID:27340676

  9. Linagliptin monotherapy compared with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis: a 12-week randomized trial

    PubMed Central

    Mori, Katsuhito; Emoto, Masanori; Shoji, Tetsuo; Inaba, Masaaki

    2016-01-01

    Objective Focusing on efficacy and tolerability, we compared linagliptin monotherapy with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis (HD). Research design and methods In this multicenter, randomized, open-label, parallel-group, active-controlled study, 78 patients were randomized (1:1) to receive a 12-week treatment with 5 mg linagliptin once daily or 0.2 mg voglibose three times a day. To assess whether linagliptin was superior to voglibose, the primary efficacy end point was the change in glycated hemoglobin (HbA1c) level between baseline and week 12. Secondary efficacy end points included changes between baseline and week 12 in glycated albumin (GA) and casual plasma glucose (PG) levels. Results At week 12, the adjusted mean HbA1c levels had decreased by −0.60% after treatment with linagliptin and by −0.20% after treatment with voglibose (treatment difference: −0.40%, 95% CI −0.74% to −0.06%, p=0.022). A significant reduction in casual PG level was also observed after treatment with linagliptin compared with treatment with voglibose. Relative to voglibose, linagliptin tended to elicit reductions in GA, although without statistical significance. No hypoglycemic symptoms or severe hypoglycemia occurred during the study. Conclusions In patients with type 2 diabetes undergoing HD, linagliptin monotherapy provided significantly better glycemic control without severe hypoglycemia than voglibose monotherapy. Linagliptin represents a promising agent for glycemic management in patients with type 2 diabetes undergoing HD. Trial registration number UMIN000007635; results. PMID:27547421

  10. Effects of Cardiovascular Disease Risk Communication for Patients With Type 2 Diabetes on Risk Perception in a Randomized Controlled Trial

    PubMed Central

    Welschen, Laura M.C.; Bot, Sandra D.M.; Kostense, Piet J.; Dekker, Jacqueline M.; Timmermans, Daniëlle R.M.; van der Weijden, Trudy; Nijpels, Giel

    2012-01-01

    OBJECTIVE Patients with type 2 diabetes mellitus (T2DM) underestimate their risk of developing severe complications, and they do not always understand the risk communication by their caregivers. The aim of this study was to investigate the effects of an intervention focused on the communication of the absolute 10-year risk of developing cardiovascular disease (CVD) in patients with T2DM. RESEARCH DESIGN AND METHODS A randomized controlled trial was performed in T2DM patients newly referred to the Diabetes Care System (DCS) West-Friesland, a managed-care system in the Netherlands. The intervention group (n = 131) received a six-step CVD risk communication. Control subjects (n = 130) received standard managed care. The primary outcome measure was appropriateness of risk perception (difference between actual CVD risk calculated by the UK Prospective Diabetes Study risk engine and risk perception). Secondary outcome measures were illness perceptions, attitude and intention to change behavior, satisfaction with the communication, and anxiety and worry about CVD risk. Patients completed questionnaires at baseline, at 2 weeks (immediately after the intervention), and at 12 weeks. RESULTS Appropriateness of risk perception improved between the intervention and control groups at 2 weeks. This effect disappeared at 12 weeks. No effects were found on illness perceptions, attitude and intention to change behavior, or anxiety and worry about CVD risk. Patients in the intervention group were significantly more satisfied with the communication. CONCLUSIONS This risk communication method improved patients’ risk perception at 2 weeks but not at 12 weeks. Negative effects were not found, as patients did not become anxious or worried after the CVD risk communication. PMID:22923669

  11. An Education- and Telephone-Based Intervention to Improve Follow-up to Vision Care in Patients With Diabetes: A Prospective, Single-Blinded, Randomized Trial.

    PubMed

    Zangalli, Camila S; Murchison, Ann P; Hale, Nicole; Hark, Lisa A; Pizzi, Laura T; Dai, Yang; Leiby, Benjamin E; Haller, Julia A

    2016-01-01

    The aim was to evaluate the effectiveness of a multipronged intervention on diabetic dilated fundus examination (DFE) adherence. In a prospective trial, 521 patients with diabetes who were due for follow-up DFEs were randomized to usual care or the intervention group. Usual care received a form letter reminder to schedule and an automated reminder phone call prior to their appointment. Intervention participants received an educational brochure about diabetic eye disease and a personalized letter reminder to schedule. A research assistant called intervention participants to help schedule the appointment, and they received a reminder letter and an automated phone call prior to the scheduled visit. Patients in the intervention group were significantly more likely to schedule (63% vs 40%; P < .0001) and complete their appointment (48% vs 30%; P < .0001) compared with usual care. A multipronged intervention, including an educational mailing and telephone assistance with scheduling an appointment, significantly improved diabetic DFE adherence. PMID:25270737

  12. Scaling-up from an implementation trial to state-wide coverage: results from the preliminary Melbourne Diabetes Prevention Study

    PubMed Central

    2012-01-01

    Background The successful Greater Green Triangle Diabetes Prevention Program (GGT DPP), a small implementation trial, has been scaled-up to the Victorian state-wide ‘Life!’ programme with over 10,000 individuals enrolled. The Melbourne Diabetes Prevention Study (MDPS) is an evaluation of the translation from the GGT DPP to the Life! programme. We report results from the preliminary phase (pMDPS) of this evaluation. Methods The pMDPS is a randomised controlled trial with 92 individuals aged 50 to 75 at high risk of developing type 2 diabetes randomised to Life! or usual care. Intervention consisted of six structured 90-minute group sessions: five fortnightly sessions and the final session at 8 months. Participants underwent anthropometric and laboratory tests at baseline and 12 months, and provided self-reported psychosocial, dietary, and physical activity measures. Intervention group participants additionally underwent these tests at 3 months. Paired t tests were used to analyse within-group changes over time. Chi-square tests were used to analyse differences between groups in goals met at 12 months. Differences between groups for changes over time were tested with generalised estimating equations and analysis of covariance. Results Intervention participants significantly improved at 12 months in mean body mass index (−0.98 kg/m2, standard error (SE) = 0.26), weight (−2.65 kg, SE = 0.72), waist circumference (−7.45 cm, SE = 1.15), and systolic blood pressure (−3.18 mmHg, SE = 1.26), increased high-density lipoprotein-cholesterol (0.07 mmol/l, SE = 0.03), reduced energy from total (−2.00%, SE = 0.78) and saturated fat (−1.54%, SE = 0.41), and increased fibre intake (1.98 g/1,000 kcal energy, SE = 0.47). In controls, oral glucose at 2 hours deteriorated (0.59 mmol/l, SE = 0.27). Only waist circumference reduced significantly (−4.02 cm, SE = 0.95). Intervention participants significantly outperformed controls

  13. A Randomised Controlled Trial to Delay or Prevent Type 2 Diabetes after Gestational Diabetes: Walking for Exercise and Nutrition to Prevent Diabetes for You.

    PubMed

    Peacock, A S; Bogossian, F E; Wilkinson, S A; Gibbons, K S; Kim, C; McIntyre, H D

    2015-01-01

    Aims. To develop a program to support behaviour changes for women with a history of Gestational Diabetes Mellitus (GDM) and a Body Mass Index (BMI) > 25 kg/m(2) to delay or prevent Type 2 Diabetes Mellitus. Methods. Women diagnosed with GDM in the previous 6 to 24 months and BMI > 25 kg/m(2) were randomized to an intervention (I) (n = 16) or a control (C) (n = 15) group. The intervention was a pedometer program combined with nutrition coaching, with the primary outcome increased weight loss in the intervention group. Secondary outcomes included decreased waist and hip measurements, improved insulin sensitivity and body composition, increased physical activity, and improved self-efficacy in eating behaviours. Results. Median (IQR) results were as follows: weight: I -2.5 (2.3) kg versus C +0.2 (1.6) kg (P = 0.009), waist: I -3.6 (4.5) cm versus C -0.1 (3.6) cm (P = 0.07), and hip: I -5.0 (3.3) cm versus C -0.2 (2.6) cm (P = 0.002). There was clinical improvement in physical activity and eating behaviours and no significant changes in glucose metabolism or body composition. Conclusion. A pedometer program and nutrition coaching proved effective in supporting weight loss, waist circumference, physical activity, and eating behaviours in women with previous GDM. PMID:26089886

  14. The Role of Hypoglycemia in Cardiovascular Outcomes in Diabetes.

    PubMed

    Paty, Breay W

    2015-12-01

    Intensive glucose management, targeting lower glycated hemoglobin (A1C) levels, has been shown to reduce the microvascular complications of diabetes, but the effect on cardiovascular (CV) outcomes is less clear. Observational follow-up of intensive glucose management studies suggest possible long-term CV benefits, but no clear reduction in CV events has been seen over 3 to 5 years. Intensive glucose management also increases the risk for hypoglycemia, particularly in patients with longstanding diabetes, cognitive impairment and hypoglycemia unawareness. Severe hypoglycemia has been linked to adverse consequences, including cardiac dysrhythmias, CV events and death, but the precise role of hypoglycemia in CV outcomes is uncertain. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial was terminated early because of a higher rate of CV events in the intensive arm. Post hoc analyses of ACCORD and other trials suggest that cardiac autonomic neuropathy may be a predisposing factor to CV events. The Analyses of the Action in Diabetes and Vascular Disease (ADVANCE) trial and the Veterans Affairs Diabetes Trial (VADT) showed that subjects with severe hypoglycemia had more frequent adverse outcomes. However, rather than causing adverse events, it appears that severe hypoglycemia may be a marker of vulnerability for such events. This review focuses on the current understanding of the association between hypoglycemia and CV risk. PMID:26654859

  15. Nurse-led telecoaching of people with type 2 diabetes in primary care: rationale, design and baseline data of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Despite the efforts of the healthcare community to improve the quality of diabetes care, about 50% of people with type 2 diabetes do not reach their treatment targets, increasing the risk of future micro-and macro-vascular complications. Diabetes self-management education has been shown to contribute to better disease control. However, it is not known which strategies involving educational programs are cost-effective. Telehealth applications might support chronic disease management. Transferability of successful distant patient self-management support programs to the Belgian setting needs to be confirmed by studies of a high methodological quality. “The COACH Program” was developed in Australia as target driven educational telephone delivered intervention to support people with different chronic conditions. It proved to be effective in patients with coronary heart disease after hospitalization. Clinical and cost-effectiveness of The COACH Program in people with type 2 diabetes in Belgium needs to be assessed. Methods/Design Randomized controlled trial in patients with type 2 diabetes. Patients were selected based on their medication consumption data and were recruited by their sickness fund. They were randomized to receive either usual care plus “The COACH Program” or usual care alone. The study will assess the difference in outcomes between groups. The primary outcome measure is the level of HbA1c. The secondary outcomes are: Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Blood Pressure, body mass index, smoking status; proportion of people at target for HbA1c, LDL-Cholesterol and Blood Pressure; self-perceived health status, diabetes-specific emotional distress and satisfaction with diabetes care. The follow-up period is 18 months. Within-trial and modeled cost-utility analyses, to project effects over life-time horizon beyond the trial duration, will be undertaken from the perspective of the health care system if the

  16. Medication burden in the first 5 years following diagnosis of type 2 diabetes: findings from the ADDITION-UK trial cohort

    PubMed Central

    Black, James A; Simmons, Rebecca K; Boothby, Clare E; Davies, Melanie J; Webb, David; Khunti, Kamlesh; Long, Gráinne H; Griffin, Simon J

    2015-01-01

    Introduction Individuals with screen-detected diabetes are likely to receive intensified pharmacotherapy to improve glycaemic control and general cardiometabolic health. Individuals are often asymptomatic, and little is known about the degree to which polypharmacy is present both before, and after diagnosis. We aimed to describe and characterize the pharmacotherapy burden of individuals with screen-detected diabetes at diagnosis, 1 and 5 years post-diagnosis. Methods The prescription histories of 1026 individuals with screen-detected diabetes enrolled in the ADDITION-UK trial of the promotion of intensive treatment were coded into general medication types at diagnosis, 1 and 5 years post-diagnosis. The association between change in the count of several medication types and age, baseline 10-year UK Prospective Diabetes Study (UKPDS) cardiovascular disease (CVD risk), sex, intensive treatment group and number of medications was explored. Results Just under half of individuals were on drugs unrelated to cardioprotection before diagnosis (42%), and this increased along with a rise in the number of prescribed diabetes-related and cardioprotective drugs. The medication profile over the first 5 years suggests multimorbidity and polypharmacy is present in individuals with screen-detected diabetes. Higher modeled CVD risk at baseline was associated with a greater increase in cardioprotective and diabetes-related medication, but not an increase in other medications. Conclusion As recommended in national guidelines, our results suggest that treatment of diabetes was influenced by the underlying risk of CVD. While many individuals did not start glucose lowering and cardioprotective therapies in the first 5 years after diagnosis, more information is required to understand whether this represents unmet need, or patient-centered care. Trial registration number CNT00237549. PMID:26448867

  17. Psychosocial and Clinical Outcomes of a Cognitive Behavioral Therapy for Asians and Pacific Islanders with Type 2 Diabetes: A Randomized Clinical Trial.

    PubMed

    Inouye, Jillian; Li, Dongmei; Davis, James; Arakaki, Richard

    2015-11-01

    Asian Americans and Pacific Islanders are twice as likely to be diagnosed with type 2 diabetes compared to Caucasians. The objective was to determine the effect of cognitive behavioral therapy on quality of life, general health perceptions, depressive symptoms, and glycemia in Asians and Pacific Islanders with type 2 diabetes. The design was a randomized controlled clinical trial comparing cognitive behavioral therapy to diabetes education and support for six weekly sessions. Participants were recruited from two endocrinology practices; 207 were enrolled. The cognitive behavioral therapy group was provided self-management tools which included biofeedback, breathing exercises, and stress relievers, while the diabetes education and support group included diabetes education and group discussions. Assessments of psychosocial and clinical outcomes were obtained before and after sessions and 12 months PostSession. Differences between the two groups were examined using linear mixed-effects models with linear contrasts. The cognitive behavioral therapy group had improved depressive symptom scores from PreSession to EndSession compared to the diabetes education and support group (P < .03), but the improvement did not extend to 12 months PostSession. Similar results were observed with misguided support scores in the Multidimensional Diabetes Questionnaire (P < .03) and susceptibility in health beliefs (P < .01), but no significant differences in HbA1c improvement were found between the two groups. Both interventions improved outcomes from baseline but were not sustained for 1 year. PMID:26568899

  18. Psychosocial and Clinical Outcomes of a Cognitive Behavioral Therapy for Asians and Pacific Islanders with Type 2 Diabetes: A Randomized Clinical Trial

    PubMed Central

    Li, Dongmei; Davis, James; Arakaki, Richard

    2015-01-01

    Asian Americans and Pacific Islanders are twice as likely to be diagnosed with type 2 diabetes compared to Caucasians. The objective was to determine the effect of cognitive behavioral therapy on quality of life, general health perceptions, depressive symptoms, and glycemia in Asians and Pacific Islanders with type 2 diabetes. The design was a randomized controlled clinical trial comparing cognitive behavioral therapy to diabetes education and support for six weekly sessions. Participants were recruited from two endocrinology practices; 207 were enrolled. The cognitive behavioral therapy group was provided self-management tools which included biofeedback, breathing exercises, and stress relievers, while the diabetes education and support group included diabetes education and group discussions. Assessments of psychosocial and clinical outcomes were obtained before and after sessions and 12 months PostSession. Differences between the two groups were examined using linear mixed-effects models with linear contrasts. The cognitive behavioral therapy group had improved depressive symptom scores from PreSession to EndSession compared to the diabetes education and support group (P < .03), but the improvement did not extend to 12 months PostSession. Similar results were observed with misguided support scores in the Multidimensional Diabetes Questionnaire (P < .03) and susceptibility in health beliefs (P < .01), but no significant differences in HbA1c improvement were found between the two groups. Both interventions improved outcomes from baseline but were not sustained for 1 year. PMID:26568899

  19. Cardiovascular outcomes with antihypertensive therapy in type 2 diabetes: an analysis of intervention trials.

    PubMed

    Jerums, G; Panagiotopoulos, S; Ekinci, E; MacIsaac, R J

    2015-08-01

    In studies of antihypertensive therapy, relative cardiovascular (CV) risk reduction is largely independent of attained systolic blood pressure (SBP). How this translates to absolute risk reduction (ARR) in diabetes is not clear. We have compared 5-year CV outcomes in 10 studies of intensive versus moderate or active versus placebo therapy in subjects with type 2 diabetes and attained SBP < or ⩾ 140 mm Hg. Attained SBP ⩾ 140 mm Hg occurred in five early studies (HOT n = 1001, UKPDS n = 1148, SHEP n = 583, SYSTEUR n = 422, MICRO_HOPE n = 3377) and attained SBP<140 mm Hg occurred in five recent studies (ABCD-NT n = 480, ADVANCE n = 11,140 INVEST n = 4266, ACCORD n = 4733, ROADMAP n= 4447). In each study, ARR was calculated from group mean data and expressed as % change in CV events over 5 years per 10 mm Hg decrease in attained SBP. In studies with attained SBP ⩾ 140 mm Hg, ARR was 13 ± 2.6% per 10 mm Hg, and the number needed to treat (NNT) to prevent one event in 5 years was 8. In studies with attained SBP < 140 mm Hg, ARR was 1.6 ± 1 .9% per 10 mm Hg (P = 0.0007), and NNT was 68. The present analysis indicates that CV outcomes reach a plateau after attaining SBP of 140 mm Hg in patients with type 2 diabetes. PMID:25608943

  20. Determination of efficacy of reflexology in managing patients with diabetic neuropathy: a randomized controlled clinical trial.

    PubMed

    Dalal, Krishna; Maran, V Bharathi; Pandey, Ravindra M; Tripathi, Manjari

    2014-01-01

    Background. The restricted usage of existing pharmacological methods which do not seem to provide the treatment of diabetic neuropathy may lead to exploring the efficacy of a complementary therapy. In this context, this paper was devoted to evaluate the efficacy of foot reflexology. This health science works on the hypothesis that the dysfunctional states of body parts could be identified by observing certain skin features and be rectified by stimulating certain specific areas mapped on feet. Method. Subjects (N = 58) with diagnosed diabetic neuropathy were randomly distributed into reflexology and control groups in which both group patients were treated with ongoing pharmacological drugs. Reflexology group patients were additionally treated holistically with the hypothesis that this therapy would bring homeostasis among body organ functions. This was a caregiver-based study with a follow-up period of 6 months. The outcome measures were pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities. The skin features leading to the detection of the abnormal functional states of body parts were also recorded and analyzed. Results. Reflexology group showed more improvements in all outcome measures than those of control subjects with statistical significance. Conclusion. This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy. PMID:24527055

  1. DIABETES

    PubMed Central

    Urano, Fumihiko

    2014-01-01

    Limited options for clinical management of patients with juvenile-onset diabetes mellitus call for a novel therapeutic paradigm. Two innovative studies support endoplasmic reticulum as an emerging target for combating both autoimmune and heritable forms of this disease. PMID:24393784

  2. Effect of breviscapine injection on clinical parameters in diabetic nephropathy: A meta-analysis of randomized controlled trials

    PubMed Central

    Liu, Xiaodan; Yao, Li; Sun, Da; Zhu, Xinwang; Liu, Qiang; Xu, Tianhua; Wang, Lining

    2016-01-01

    Diabetic nephropathy (DN) is currently a major public health problem worldwide. The objective of the present study was to evaluate the clinical effect of breviscapine injections in patients with DN. A meta-analysis was performed using the following databases to obtain published reports in any language: PubMed/MEDLINE, Embase, China National Knowledge Infrastructure, Chinese Evidence-Based Medicine, Wanfang Digital Periodicals, Chinese Academic Journals Full-text Database, Chinese Biological and Medical Database, China Doctoral and Masters Dissertations Full-text Database and the Chinese Proceedings of Conference Full-text Database. Two assessors independently reviewed each trial. A total of 35 randomized controlled trials, which performed studies on a total of 2,320 patients (1,188 in treatment groups and 1,132 in control groups), were included in the present meta-analysis. Data were analyzed using Stata version 11.0 for Windows. The results from the analysis demonstrated that breviscapine injections have greater therapeutic effects in patients with DN in comparison with the control group, including renal protective effects (reducing urine protein, serum creatinine and blood urea nitrogen) and adjustment for dyslipidemia (affecting levels of cholesterol, triglycerides and high density lipoproteins). These effects indicate that breviscapine injections are beneficial to patients with DN. Further studies are required to determine the mechanisms underlying the therapeutic effects of breviscapine. PMID:27588060

  3. The Management of Diabetic Foot Ulcers with Porcine Small Intestine Submucosa Tri-Layer Matrix: A Randomized Controlled Trial

    PubMed Central

    Cazzell, Shawn M.; Lange, Darrell L.; Dickerson, Jaime E.; Slade, Herbert B.

    2015-01-01

    Objective: This study demonstrates that superior outcomes are possible when diabetic foot ulcers (DFU) are managed with tri-layer porcine small intestine submucosa (SIS). Approach: Patients with DFU from 11 centers participated in this prospective randomized controlled trial. Qualified subjects were randomized (1:1) to either SIS or standard care (SC) selected at the discretion of the Investigator and followed for 12 weeks or complete ulcer closure. Results: Eighty-two subjects (41 in each group) were evaluable in the intent-to-treat analysis. Ulcers managed with SIS had a significantly greater proportion closed by 12 weeks than for the Control group (54% vs. 32%, p=0.021) and this proportion was numerically higher at all visits. Time to closure for ulcers achieving closure was 2 weeks earlier for the SIS group than for SC. Median reduction in ulcer area was significantly greater for SIS at each weekly visit (all p values<0.05). Review of reported adverse events found no safety concerns. Innovation: These data support the use of tri-layer SIS for the effective management of DFU. Conclusion: In this randomized controlled trial, SIS was found to be associated with more rapid improvement, and a higher likelihood of achieving complete ulcer closure than those ulcers treated with SC. PMID:26634183

  4. A Randomised Controlled Trial to Delay or Prevent Type 2 Diabetes after Gestational Diabetes: Walking for Exercise and Nutrition to Prevent Diabetes for You

    PubMed Central

    Bogossian, F. E.; Wilkinson, S. A.; Gibbons, K. S.; Kim, C.

    2015-01-01

    Aims. To develop a program to support behaviour changes for women with a history of Gestational Diabetes Mellitus (GDM) and a Body Mass Index (BMI) > 25 kg/m2 to delay or prevent Type 2 Diabetes Mellitus. Methods. Women diagnosed with GDM in the previous 6 to 24 months and BMI > 25 kg/m2 were randomized to an intervention (I) (n = 16) or a control (C) (n = 15) group. The intervention was a pedometer program combined with nutrition coaching, with the primary outcome increased weight loss in the intervention group. Secondary outcomes included decreased waist and hip measurements, improved insulin sensitivity and body composition, increased physical activity, and improved self-efficacy in eating behaviours. Results. Median (IQR) results were as follows: weight: I −2.5 (2.3) kg versus C +0.2 (1.6) kg (P = 0.009), waist: I −3.6 (4.5) cm versus C −0.1 (3.6) cm (P = 0.07), and hip: I −5.0 (3.3) cm versus C −0.2 (2.6) cm (P = 0.002). There was clinical improvement in physical activity and eating behaviours and no significant changes in glucose metabolism or body composition. Conclusion. A pedometer program and nutrition coaching proved effective in supporting weight loss, waist circumference, physical activity, and eating behaviours in women with previous GDM. PMID:26089886

  5. Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial

    PubMed Central

    McAlister, Finlay Aleck; Wood, Peter William; Boulanger, Pierre; Fradette, Miriam; Klarenbach, Scott; Edwards, Alun L; Holroyd-Leduc, Jayna M; Alagiakrishnan, Kannayiram; Rabi, Doreen; Majumdar, Sumit Ranjan

    2016-01-01

    Background Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving “optimal BP control” (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring—the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management. Objective To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with “enhanced usual care” in community-dwelling seniors with diabetes and hypertension. Methods A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors’ residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management. Results Outcomes will be

  6. Revolution in Detection Affairs

    SciTech Connect

    Stern W.

    2013-11-02

    The detection of nuclear or radioactive materials for homeland or national security purposes is inherently difficult. This is one reason detection efforts must be seen as just one part of an overall nuclear defense strategy which includes, inter alia, material security, detection, interdiction, consequence management and recovery. Nevertheless, one could argue that there has been a revolution in detection affairs in the past several decades as the innovative application of new technology has changed the character and conduct of detection operations. This revolution will likely be most effectively reinforced in the coming decades with the networking of detectors and innovative application of anomaly detection algorithms.

  7. Treatment of chronic diabetic lower leg ulcers with activated protein C: a randomised placebo-controlled, double-blind pilot clinical trial.

    PubMed

    Whitmont, Kaley; McKelvey, Kelly J; Fulcher, Gregory; Reid, Ian; March, Lyn; Xue, Meilang; Cooper, Alan; Jackson, Christopher J

    2015-08-01

    Lower leg ulcers are a serious and long-term complication in patients with diabetes and pose a major health concern because of the increasing number of patients diagnosed with diabetes each year. This study sought to evaluate the clinical benefit of topical activated protein C (APC) on chronic lower leg ulcers in patients with diabetes. Twelve patients were randomly assigned to receive either APC (N = 6) or physiological saline (placebo; N = 6) in a randomised, placebo-controlled, double-blind pilot clinical trial. Treatment was administered topically, twice weekly for 6 weeks with final follow-up at 20 weeks. Wound area was significantly reduced to 34·8 ± 16·4% of week 0 levels at 20 weeks in APC-treated wounds (p = 0·01). At 20 weeks, three APC-treated wounds had completely healed, compared to one saline-treated wound. Full-thickness wound edge skin biopsies showed reduced inflammatory cell infiltration and increased vascular proliferation following APC treatment. Patient stress scores were also significantly reduced following APC treatment (p < 0·05), demonstrating improved patient quality of life as assessed by the Cardiff Wound Impact Questionnaire. This pilot trial suggests that APC is a safe topical agent for healing chronic lower leg ulcers in patients with diabetes and provides supporting evidence for a larger clinical trial. PMID:23848141

  8. Three Year Outcomes of Bariatric Surgery vs. Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Trial

    PubMed Central

    Courcoulas, Anita P.; Belle, Steven H.; Neiberg, Rebecca H.; Pierson, Sheila K.; Eagleton, Jessie K; Kalarchian, Melissa A.; DeLany, James P.; Lang, Wei; Jakicic, John M.

    2016-01-01

    IMPORTANCE Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM). OBJECTIVE This study compared the remission of T2DM following surgical and non-surgical treatments. DESIGN Randomized Controlled Trial SETTING University of Pittsburgh Medical Center, in the United States. PARTICIPANTS and INTERVENTIONS Outcomes were assessed 3 years after treating 61 obese participants with T2DM who were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a lower lifestyle weight loss intervention (LLLI) for 2 years or surgical treatments [Roux en Y gastric bypass (RYGB) or Laparoscopic adjustable gastric banding (LAGB)] followed by LLLI in years 2 and 3. MAIN OUTCOME MEASURES Primary endpoints were partial and complete diabetes remission and secondary endpoints included diabetes medications and weight change. RESULTS Body mass index was <35kg/m2 for 26 (43%) participants, 50 (82%) were women, and 13 (21%) African American. Mean (SD) values for weight were 100.5 (13.7) kg, age 47.3 (6.6) years, hemoglobin A1c level 7.8% (1.9%), and fasting plasma glucose 171.3 (72.5) mg/dL. Partial or complete T2DM remission was achieved by 40% (n=8) of RYGB, 29% (n=6) of LAGB, and no LWLI participants (p=0.0037). The use of diabetes medications was reduced more in the surgical groups than the lifestyle alone group; with 65% of RYGB, 33% of LAGB, and 0% of LWLI going from using insulin or oral medication at baseline to no medication at year 3 (p<0.0001). Mean (SE) reductions in percent body weight at 3 years was the greatest after RYGB 25.0% (2.0), followed by LAGB 15.0% (2.0) and lifestyle treatment 5.7% (2.4) (p<0.01). CONCLUSIONS Among obese participants with T2DM, bariatric surgery with 2 years of an adjunctive LLLI resulted in more disease remission than did lifestyle intervention alone. PMID:26132586

  9. Breakfast replacement with a low-glycaemic response liquid formula in patients with type 2 diabetes: a randomised clinical trial.

    PubMed

    Stenvers, Dirk J; Schouten, Lydia J; Jurgens, Jordy; Endert, Erik; Kalsbeek, Andries; Fliers, Eric; Bisschop, Peter H

    2014-08-28

    Low-glycaemic index diets reduce glycated Hb (HbA1c) in patients with type 2 diabetes, but require intensive dietary support. Using a liquid meal replacement with a low glycaemic response (GR) may be an alternative dietary approach. In the present study, we investigated whether breakfast replacement with a low-GR liquid meal would reduce postprandial glycaemia and/or improve long-term glycaemia. In the present randomised, controlled, cross-over design, twenty patients with type 2 diabetes consumed either a breakfast replacement consisting of an isoenergetic amount of Glucerna SR or a free-choice breakfast for 3 months. Postprandial AUC levels were measured using continuous glucose measurement at home. After the 3-month dietary period, meal profiles and oral glucose tolerance were assessed in the clinical setting. The low-GR liquid meal replacement reduced the AUC of postprandial glucose excursions at home compared with a free-choice control breakfast (estimated marginal mean 141 (95 % CI 114, 174) v. estimated marginal mean 259 (95 % CI 211, 318) mmol × min/l; P= 0·0002). The low-GR liquid meal replacement also reduced glucose AUC levels in the clinical setting compared with an isoenergetic control breakfast (low GR: median 97 (interquartile range (IQR) 60-188) mmol × min/l; control: median 253 (IQR 162-386) mmol × min/l; P< 0·001). However, the 3-month low-GR liquid meal replacement did not affect fasting plasma glucose, HbA1c or lipid levels, and even slightly reduced oral glucose tolerance. In conclusion, the low-GR liquid meal replacement is a potential dietary approach to reduce postprandial glycaemia in patients with type 2 diabetes. However, clinical trials into the effects of replacing multiple meals on long-term glycaemia in poorly controlled patients are required before a low-GR liquid meal replacement can be adopted as a dietary approach to the treatment of type 2 diabetes. PMID:25091284

  10. Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial

    PubMed Central

    2013-01-01

    Background Diabetic foot ulcers (DFUs) represent a significant source of morbidity and an enormous financial burden. Standard care for DFUs involves systemic glucose control, ensuring adequate perfusion, debridement of nonviable tissue, off-loading, control of infection, local wound care and patient education, all administered by a multidisciplinary team. Unfortunately, even with the best standard of care (SOC) available, only 24% or 30% of DFUs will heal at weeks 12 or 20, respectively. The extracellular matrix (ECM) in DFUs is abnormal and its impairment has been proposed as a key target for new therapeutic devices. These devices intend to replace the aberrant ECM by implanting a matrix, either devoid of cells or enhanced with fibroblasts, keratinocytes or both as well as various growth factors. These new bioengineered skin substitutes are proposed to encourage angiogenesis and in-growth of new tissue, and to utilize living cells to generate cytokines needed for wound repair. To date, the efficacy of bioengineered ECM containing live cellular elements for improving healing above that of a SOC control group has not been compared with the efficacy of an ECM devoid of cells relative to the same SOC. Our hypothesis is that there is no difference in the improved healing effected by either of these two product types relative to SOC. Methods/Design To test this hypothesis we propose a randomized, single-blind, clinical trial with three arms: SOC, SOC plus Dermagraft® (bioengineered ECM containing living fibroblasts) and SOC plus Oasis® (ECM devoid of living cells) in patients with nonhealing DFUs. The primary outcome is the percentage of subjects that achieved complete wound closure by week 12. Discussion If our hypothesis is correct, then immense cost savings could be realized by using the orders-of-magnitude less expensive acellular ECM device without compromising patient health outcomes. The article describes the protocol proposed to test our hypothesis. Trial

  11. Effect of Tree Nuts on Glycemic Control in Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Dietary Trials

    PubMed Central

    Viguiliouk, Effie; Kendall, Cyril W. C.; Blanco Mejia, Sonia; Cozma, Adrian I.; Ha, Vanessa; Mirrahimi, Arash; Jayalath, Viranda H.; Augustin, Livia S. A.; Chiavaroli, Laura; Leiter, Lawrence A.; de Souza, Russell J.; Jenkins, David J. A.; Sievenpiper, John L.

    2014-01-01

    Background Tree nut consumption has been associated with reduced diabetes risk, however, results from randomized trials on glycemic control have been inconsistent. Objective To provide better evidence for diabetes guidelines development, we conducted a systematic review and meta-analysis of randomized controlled trials to assess the effects of tree nuts on markers of glycemic control in individuals with diabetes. Data Sources MEDLINE, EMBASE, CINAHL, and Cochrane databases through 6 April 2014. Study Selection Randomized controlled trials ≥3 weeks conducted in individuals with diabetes that compare the effect of diets emphasizing tree nuts to isocaloric diets without tree nuts on HbA1c, fasting glucose, fasting insulin, and HOMA-IR. Data Extraction and Synthesis Two independent reviewer’s extracted relevant data and assessed study quality and risk of bias. Data were pooled by the generic inverse variance method and expressed as mean differences (MD) with 95% CI’s. Heterogeneity was assessed (Cochran Q-statistic) and quantified (I2). Results Twelve trials (n = 450) were included. Diets emphasizing tree nuts at a median dose of 56 g/d significantly lowered HbA1c (MD = −0.07% [95% CI:−0.10, −0.03%]; P = 0.0003) and fasting glucose (MD = −0.15 mmol/L [95% CI: −0.27, −0.02 mmol/L]; P = 0.03) compared with control diets. No significant treatment effects were observed for fasting insulin and HOMA-IR, however the direction of effect favoured tree nuts. Limitations Majority of trials were of short duration and poor quality. Conclusions Pooled analyses show that tree nuts improve glycemic control in individuals with type 2 diabetes, supporting their inclusion in a healthy diet. Owing to the uncertainties in our analyses there is a need for longer, higher quality trials with a focus on using nuts to displace high-glycemic index carbohydrates. Trial Registration ClinicalTrials.gov NCT01630980 PMID:25076495

  12. A pilot randomised controlled trial of a preconsultation web-based intervention to improve the care quality and clinical outcomes of diabetes outpatients (DIAT)

    PubMed Central

    Frost, Julia; Anderson, Rob; Argyle, Catherine; Daly, Mark; Harris-Golesworthy, Faith; Harris, Jim; Gibson, Andy; Ingram, Wendy; Pinkney, Jon; Ukoumunne, Obioha C; Vaidya, Bijay; Vickery, Jane; Britten, Nicky

    2013-01-01

    Introduction Diabetes is a chronic condition associated with many long-term complications. People with diabetes need to actively manage their condition, which can be complex. In consultations with healthcare professionals, patients receive advice about their diabetes but do not always discuss things which concern them, perhaps because of the perceived limited time or embarrassment. We want to test a ‘preconsultation’ intervention in which the patient is supported by a healthcare assistant to complete a web-based intervention aimed at producing an agenda to help them identify important areas for discussion in the consultation. Use of this agenda may enable the patient to play a more active role in that consultation and consequently become more confident, and hence more successful, in managing their condition. Methods and analysis In this pilot randomised controlled trial, 120 people with diabetes will be randomised with equal allocation to receive the intervention or usual clinical care. The primary outcome is reduction in glycosylated haemoglobin(HbA1c). Secondary outcomes are patient-reported communication, enablement, self-care activity, diabetes-dependent quality of life, empowerment, satisfaction, health-related quality of life and resource use. The aim of the pilot study was to estimate parameters to inform the design of the definitive trial. Follow-up on quantitative outcomes will be at 3 and 6 months. A nested qualitative study will collect data on the patients’ experiences of producing an agenda. Resource use data and medication use will also be collected via a review of medical records for a sample of participants. Ethics and dissemination Approval was granted by the NHS Research Ethics Committee North West—Preston (13/NW/0123). Dissemination will include publication of quantitative and qualitative findings, and experience of public involvement in peer-reviewed journals. Results will also be disseminated to trial participants via workshops led by

  13. Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy in TYpe 2 diabetic patients with normoalbuminuria (PRIORITY): essential study design and rationale of a randomised clinical multicentre trial

    PubMed Central

    Lindhardt, Morten; Currie, Gemma; Pontillo, Claudia; Beige, Joachim; Delles, Christian; von der Leyen, Heiko; Mischak, Harald; Navis, Gerjan; Noutsou, Marina; Ortiz, Alberto; Ruggenenti, Piero Luigi; Rychlik, Ivan; Spasovski, Goce; Rossing, Peter

    2016-01-01

    Introduction Diabetes mellitus affects 9% of the European population and accounts for 15% of healthcare expenditure, in particular, due to excess costs related to complications. Clinical trials aiming for earlier prevention of diabetic nephropathy by renin angiotensin system blocking treatment in normoalbumuric patients have given mixed results. This might reflect that the large fraction of normoalbuminuric patients are not at risk of progression, thereby reducing power in previous studies. A specific risk classifier based on urinary proteomics (chronic kidney disease (CKD)273) has been shown to identify normoalbuminuric diabetic patients who later progressed to overt kidney disease, and may hold the potential for selection of high-risk patients for early intervention. Combining the ability of CKD273 to identify patients at highest risk of progression with prescription of preventive aldosterone blockade only to this high-risk population will increase power. We aim to confirm performance of CKD273 in a prospective multicentre clinical trial and test the ability of spironolactone to delay progression of early diabetic nephropathy. Methods and analysis Investigator-initiated, prospective multicentre clinical trial, with randomised double-masked placebo-controlled intervention and a prospective observational study. We aim to include 3280 type 2 diabetic participants with normoalbuminuria. The CKD273 classifier will be assessed in all participants. Participants with high-risk pattern are randomised to treatment with spironolactone 25 mg once daily, or placebo, whereas, those with low-risk pattern will be observed without intervention other than standard of care. Treatment or observational period is 3 years. The primary endpoint is development of confirmed microalbuminuria in 2 of 3 first morning voids urine samples. Ethics and dissemination The study will be conducted under International Conference on Harmonisation – Good clinical practice (ICH-GCP) requirements

  14. Reduction in Weight and Cardiovascular Disease Risk Factors in Individuals With Type 2 Diabetes: One-Year Results of the Look AHEAD Trial

    PubMed Central

    2008-01-01

    Objective The effectiveness of intentional weight loss in reducing cardiovascular disease (CVD) events in type 2 diabetes is unknown. This report describes one-year changes in CVD risk factors in a trial designed to examine the long-term effects of an intensive lifestyle intervention on the incidence of major CVD events. Research Design and Methods A multi-centered randomized controlled trial of 5,145 individuals with type 2 diabetes, aged 45–74 years, with body mass index ≥25 kg/m2 (≥27 kg/m2 if taking insulin). An Intensive Lifestyle Intervention (ILI) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity was compared to a Diabetes Support and Education (DSE) condition. Results Participants assigned to ILI lost an average 8.6% of their initial weight versus 0.7% in DSE group (p<0.001). Mean fitness increased in ILI by 20.9% versus 5.8% in DSE (p<0.001). A greater proportion of ILI participants had reductions in diabetes, hypertension, and lipid-lowering medicines. Mean HbA1c dropped from 7.3% to 6.6% in ILI (p<0.001) versus from 7.3% to 7.2% in DSE. Systolic and diastolic pressure, triglycerides, HDL-cholesterol, and urine albumin/creatinine improved significantly more in ILI than DSE participants (all p<0.01). Conclusions At 1 year, ILI resulted in clinically significant weight loss in persons with type 2 diabetes. This was associated with improved diabetes control and CVD risk factors and reduced medicine use in ILI versus DSE. Continued intervention and follow-up will determine whether these changes are maintained and will reduce CVD risk. Trial Registration clinicaltrials.gov Identifier: NCT00017953 PMID:17363746

  15. One Year Post Collaborative Depression Care Trial Outcomes among Predominantly Hispanic Diabetes Safety Net Patients

    PubMed Central

    Ell, Kathleen; Katon, Wayne; Xie, Bin; Lee, Pey-Jiuan; Kapetanovic, Suad; Guterman, Jeffery; Chou, Chih-Ping

    2011-01-01

    Objective To determine sustained effectiveness in reducing depression symptoms and improving depression care one year following intervention completion. Method Of 387 low-income, predominantly Hispanic diabetes patients with major depression symptoms randomized to 12-month socio-culturally adapted collaborative care (psychotherapy and/or antidepressants, telephone symptom monitoring/relapse prevention) or enhanced usual care, 264 patients completed two-year follow-up. Depression symptoms (SCL-20, PHQ-9), treatment receipt, diabetes symptoms, and quality of life were assessed 24 months post-enrollment using intent-to-treat analyses. Results At 24 months, more intervention patients received ongoing antidepressant treatment (38% v 25%, chi-square=5.11, df=1, P=0.02); sustained depression symptom improvement (SCL-20<0.5 (adjusted OR=2.06, 95%CI=1.09–3.90, P=0.03), SCL-20 score (adjusted mean difference −0.22, P=0.001), and PHQ-9 ≥50% reduction (adjusted OR=1.87, 95%CI=1.05–3.32, P=0.03). Over 2 years, improved effects were found in significant study group by time interaction for SF-12 mental health, SDS functional impairment, diabetes symptoms, anxiety, and socioeconomic stressors (P=0.02 for SDS, P<0.0001 for all others); however, group differences narrowed over time and were no longer significant at 24 months. Conclusions Socio-culturally tailored collaborative care that included maintenance antidepressant medication, ongoing symptom monitoring and behavioral activation relapse prevention was associated with depression improvement over 24 months for predominantly Hispanic patients in primary safety net care. PMID:21774987

  16. Randomized control trial for the assessment of the anti-albuminuric effects of topiroxostat in hyperuricemic patients with diabetic nephropathy (the ETUDE study)

    PubMed Central

    Kato, Sawako; Ando, Masahiko; Mizukoshi, Toshihiro; Nagata, Takanobu; Katsuno, Takayuki; Kosugi, Tomoki; Tsuboi, Naotake; Maruyama, Shoichi

    2016-01-01

    ABSTRACT Proteinuria is an established risk factor for diabetic nephropathy. Recent studies indicate that some xanthine oxidase inhibitors have a renoprotective effect. The aim of this study was to assess whether topiroxostat reduces albuminuria in hyperuricemic patients with diabetic nephropathy and overt proteinuria. The ETUDE study is an ongoing 24-week, multicenter, open-label, randomized (1:1), parallel group study involving hyperuricemic patients with diabetic nephropathy (estimated glomerular filtration rate [eGFR] ≥ 20 mL/min/1.73 m2) and overt proteinuria (0.3 ≤ urine protein to creatinine ratio (UPCR) < 3.5 g/g Cr). Patients are randomly assigned to high dose (topiroxostat 160 mg daily) or low dose (topiroxostat 40 mg daily) on top of standard of care. The primary endpoint is the change in albuminuria indicated by urine albumin-to-creatinine ratio after 24 treated weeks relative to the baseline values. This trial was registered at the Japanese University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR: UMIN 000015403). The background, rationale, and study design of this trial are presented here. Seventy-six patients from four registered facilities have already been enrolled and received at least one dose of topiroxostat. This trial will end in 2017. The ETUDE trial is the first randomized controlled study of topiroxostat in hyperuricemic patients with diabetic nephropathy and overt proteinuria. We will clarify the pleiotropic function of topiroxostat including an anti-albumiuric effect as well as its effects on safely decreasing serum uric acid levels. PMID:27303100

  17. Can community retail pharmacist and diabetes expert support facilitate insulin initiation by family physicians? Results of the AIM@GP randomized controlled trial

    PubMed Central

    2013-01-01

    Background Limited evidence exists on the effectiveness of external diabetes support provided by diabetes specialists and community retail pharmacists to facilitate insulin-prescribing in family practice. Methods A stratified, parallel group, randomized control study was conducted in 15 sites across Canada. Family physicians received insulin initiation/titration education, a physician-specific ‘report card’ on the characteristics of their type 2 diabetes (T2DM) population, and a registry of insulin-eligible patients at a workshop. Intervention physicians in addition received: (1) diabetes specialist/educator consultation support (active diabetes specialist/educator consultation support for 2 months [the educator initiated contact every 2 weeks] and passive consultation support for 10 months [family physician initiated as needed]); and (2) community retail pharmacist support (option to refer patients to the pharmacist(s) for a 1-hour insulin-initiation session). The primary outcome was the insulin prescribing rate (IPR) per physician defined as the number of insulin starts of insulin-eligible patients during the 12-month strategy. Results Consenting, eligible physicians (n = 151) participated with 15 specialist sites and 107 community pharmacists providing the intervention. Most physicians were male (74%), and had an average of 81 patients with T2DM. Few (9%) routinely initiated patients on insulin. Physicians were randomly allocated to usual care (n = 78) or the intervention (n = 73). Intervention physicians had a mean (SE) IPR of 2.28 (0.27) compared to 2.29 (0.25) for control physicians, with an estimated adjusted RR (95% CI) of 0.99 (0.80 to 1.24), p = 0.96. Conclusions An insulin support program utilizing diabetes experts and community retail pharmacists to enhance insulin prescribing in family practice was not successful. Too few physicians are appropriately intensifying diabetes management through insulin initiation, and aggressive

  18. Changing illness perceptions in patients with poorly controlled type 2 diabetes, a randomised controlled trial of a family-based intervention: protocol and pilot study

    PubMed Central

    Keogh, Karen M; White, Patricia; Smith, Susan M; McGilloway, Sinead; O'Dowd, Tom; Gibney, James

    2007-01-01

    Background This paper presents the pilot study and protocol for a randomised controlled trial to test the effectiveness of a psychological, family-based intervention to improve outcomes in those with poorly controlled type 2 diabetes. The intervention has been designed to change the illness perceptions of patients with poorly controlled type 2 diabetes, and their family members. It is a complex psychological intervention, developed from the Self-Regulatory Model of Illness Behaviour. The important influence the family context can have in psychological interventions and diabetes management is also recognised, by the inclusion of patients' family members. Methods/design We aim to recruit 122 patients with persistently poorly controlled diabetes. Patients are deemed to have persistent poor control when at least two out of their last three HbA1c readings are 8.0% or over. Patients nominate a family member to participate with them, and this patient/family member dyad is randomly allocated to either the intervention or control group. Participants in the control group receive their usual care. Participants in the intervention group participate, with their family members, in three intervention sessions. Sessions one and two are delivered in the participant's home by a health psychologist. Session one takes place approximately one week after session two, with the third session, a follow-up telephone call, one week later. The intervention is based upon clarifying the illness perceptions of both the patient and the family member, examining how they influence self-management behaviours, improving the degree of similarity of patient and family member perceptions in a positive direction and developing personalized action plans to improve diabetes management. Discussion This study is the first of its kind to incorporate the evidence from illness perceptions research into developing and applying an intervention for people with poorly controlled diabetes and their families. This

  19. Improving mental health of adolescents with Type 1 diabetes: protocol for a randomized controlled trial of the Nothing Ventured Nothing Gained online adolescent and parenting support intervention

    PubMed Central

    2013-01-01

    Background Management of Type 1 diabetes comes with substantial personal and psychological demands particularly during adolescence, placing young people at significant risk for mental health problems. Supportive parenting can mitigate these risks, however the challenges associated with parenting a child with a chronic illness can interfere with a parent’s capacity to parent effectively. Interventions that provide support for both the adolescent and their parents are needed to prevent mental health problems in adolescents; to support positive parent-adolescent relationships; and to empower young people to better self-manage their illness. This paper presents the research protocol for a study evaluating the efficacy of the Nothing Ventured Nothing Gained online adolescent and parenting intervention which aims to improve the mental health outcomes of adolescents with Type 1 diabetes. Method/Design A randomized controlled trial using repeated measures with two arms (intervention and wait-list control) will be used to evaluate the efficacy and acceptability of the online intervention. Approximately 120 adolescents with Type 1 diabetes, aged 13–18 years and one of their parents/guardians will be recruited from pediatric diabetes clinics across Victoria, Australia. Participants will be randomized to receive the intervention immediately or to wait 6 months before accessing the intervention. Adolescent, parent and family outcomes will be assessed via self-report questionnaires at three time points (baseline, 6 weeks and 6 months). The primary outcome is improved adolescent mental health (depression and anxiety). Secondary outcomes include adolescent behavioral (diabetes self-management and risk taking behavior), psychosocial (diabetes relevant quality of life, parent reported child well-being, self-efficacy, resilience, and perceived illness benefits and burdens); metabolic (HbA1c) outcomes; parent psychosocial outcomes (negative affect and fatigue, self

  20. Student Affairs Capitalism and Early-Career Student Affairs Professionals

    ERIC Educational Resources Information Center

    Lee, Jenny J.; Helm, Matthew

    2013-01-01

    This study explores student affairs capitalism as the alteration of professional practice towards the financial interests of institutions. Student affairs capitalism has the potential to create dynamics in which the interests of students become secondary to the institution's economic needs. This study examined this phenomenon from the…

  1. Echocardiographic Evidence for Valvular Toxicity of Benfluorex: A Double-Blind Randomised Trial in Patients with Type 2 Diabetes Mellitus

    PubMed Central

    Derumeaux, Geneviève; Ernande, Laura; Serusclat, André; Servan, Evelyne; Bruckert, Eric; Rousset, Hugues; Senn, Stephen; Van Gaal, Luc; Picandet, Brigitte; Gavini, François; Moulin, Philippe

    2012-01-01

    Objectives REGULATE trial was designed to compare the efficacy and safety of benfluorex versus pioglitazone in type 2 diabetes mellitus (DM) patients. Methods Double-blind, parallel-group, international, randomised, non-inferiority trial. More than half of the 196 participating centres were primary care centres. Patients eligible had type 2 DM uncontrolled on sulfonylurea. 846 were randomised. They received study treatment for 1 year. 423 patients were allocated to benfluorex (150 to 450 mg/day) and 423 were allocated to pioglitazone (30 to 45 mg/day). Primary efficacy criterion was HbA1c. Safety assessment included blinded echocardiographic evaluation of cardiac and valvular status. Results At baseline, patients were 59.1±10.5 years old with HbA1c 8.3±0.8%, and DM duration 7.1±6.0 years. During the study, mean HbA1c significantly decreased in both groups (benfluorex: from 8.30±0.80 to 7.77±1.31 versus pioglitazone: from 8.30±0.80 to 7.45±1.30%). The last HbA1c value was significantly lower with pioglitazone than with benfluorex (p<0.001) and non-inferiority of benfluorex was not confirmed (p = 0.19). Among the 615 patients with assessable paired echocardiography (310 benfluorex, 305 pioglitazone), 314 (51%) had at least one morphological valvular abnormality and 515 (84%) at least one functional valvular abnormality at baseline. Emergent morphological abnormalities occurred in 8 patients with benfluorex versus 4 with pioglitazone (OR 1.99), 95% CI (0.59 to 6.69). Emergent regurgitation (new or increased by one grade or more) occurred more frequently with benfluorex (82 patients, 27%) than with pioglitazone (33 patients, 11%) (OR 2.97), 95% CI (1.91 to 4.63) and were mainly rated grade 1; grade 2 (mild) was detected in 2 patients with benfluorex and 3 with pioglitazone. There was no moderate or severe regurgitation. Conclusion After 1 year of exposure, our results show a 2.97 fold increase in the incidence of valvular regurgitation with benfluorex and

  2. Macular laser photocoagulation with or without intravitreal triamcinolone pretreatment for diabetic macular edema: a result from five randomized controlled trials

    PubMed Central

    Liu, Xiang-Dong; Zhou, Xiao-Dong; Wang, Zhi; Shen, Yong-Ming

    2016-01-01

    AIM To assess possible benefits of intravitreal triamcinolone acetonide (IVTA) injection as pretreatment for macular laser photocoagulation (MLP) in patients with diabetic macular edema (DME). METHODS Published randomized controlled trials (RCTs) concerning MLP with or without IVTA pretreatment for DME were retrieved from databases CNKI, Medline, EMbase, Web of Science, and the Cochrane Library. A Meta-analysis on eligible studies was conducted using RevMan 5.0 software. Two investigators independently assessed the quality of the trials and extracted data. Main outcome measures included the change in best corrected visual acuity (BCVA), difference in central macular thickness (CMT) and adverse events reporting in particular elevated intraocular pressure within the follow-up period. The results were pooled using weight mean difference (WMD) or odds risk (OR) with their corresponding 95% confidence intervals (CI). A fixed- or random-effect model was employed depending on the heterogeneity of the inclusion trials. RESULTS Finally, five independent RCTs were identified and used for comparing MLP with IVTA pretreatment (131 eyes) with MLP alone (133 eyes, control group). The overall study quality was relatively higher according to the modified Jadad scale. The Meta-analysis showed that MLP with IVTA pretreatment significantly reduced CMT at one, three and six months (P=0.002, 0.0003 and 0.04, respectively), compared with MLP alone. The IVTA pretreatment group showed statistically significant improvements in BCVA at the one-month follow up as compared with the control group (P=0.03). At three- and six-month follow up, there was a beneficial trend towards improving visual acuity in the IVTA pretreatment group without statistical significance between groups (P=0.06 and 0.20, respectively). The incidence of elevation of intraocular pressure was significantly higher in the IVTA pretreatment group than in the control group (P<0.0001). No evidence of publication bias was

  3. Baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials

    PubMed Central

    Dugel, Pravin U; Hillenkamp, Jost; Sivaprasad, Sobha; Vögeler, Jessica; Mousseau, Marie-Catherine; Wenzel, Andreas; Margaron, Philippe; Hashmonay, Ron; Massin, Pascale

    2016-01-01

    Objective This study was designed to evaluate the correlation of baseline visual acuity (VA) with VA outcome in response to anti-vascular endothelial growth factor (VEGF) in diabetic macular edema using a retrospective analysis of nine clinical trials. The result will help assess the relevance of VA gain comparisons across trials. Methods A correlation analysis was performed between mean baseline VA and VA gain at month 12 for 1,616 diabetic macular edema patients across nine randomized clinical trials (RESOLVE, RISE, RIDE, RESTORE, RETAIN, DRCR.net Protocol I, DA VINCI, VIVID, VISTA) with anti-VEGF treatment regimens ranibizumab 0.5 mg and aflibercept 2 mg. Results The mean baseline VA ranged from 56.9 to 64.8 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. The mean VA gain at month 12 ranged from 6.8 to 13.1 ETDRS letters across trials. There was a strong inverse correlation between mean baseline VA and VA gain at month 12 (r=−0.85). The mean VA at 12 months plateaued at ~70 (68.5–73.0) ETDRS letters (20/40 Snellen VA equivalent) for the anti-VEGF treatment groups from all trials, regardless of dosing regimens and agents. Conclusion Cross-trial comparisons based on changes in best-corrected visual acuity should be done cautiously and only after adjusting for best-corrected visual acuity at baseline. Furthermore, the total VA afforded by treatment appears to be subject to a plateau effect, which warrants further exploration. PMID:27366049

  4. The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial

    PubMed Central

    2010-01-01

    Background Disease management programmes (DMPs) are costly and impose additional work load on general practitioners (GPs). Data on their effectiveness are inconclusive. We therefore conducted a cluster-randomised controlled trial to evaluate the effectiveness of the Austrian DMP for diabetes mellitus type 2 on HbA1c and quality of care for adult patients in primary care. Methods All GPs of Salzburg-province were invited to participate. After cluster-randomisation by district, all patients with diabetes type 2 were recruited consecutively from 7-11/2007. The DMP, consisting mainly of physician and patient education, standardised documentation and agreement on therapeutic goals, was implemented in the intervention group while the control group received usual care. We aimed to show superiority of the intervention regarding metabolic control and process quality. The primary outcome measure was a change in HbA1c after one year. Secondary outcomes were days in the hospital, blood pressure, lipids, body mass index (BMI), enrolment in patient education and regular guideline-adherent examination. Blinding was not possible. Results 92 physicians recruited 1489 patients (649 intervention, 840 control). After 401 ± 47 days, 590 intervention-patients and 754 controls had complete data. In the intention to treat analysis (ITT) of all 1489 patients, HbA1c decreased 0.41% in the intervention group and 0.28% in controls. The difference of -0.13% (95% CI -0.24; -0.02) was significant at p = 0.026. Significance was lost in mixed models adjusted for baseline value and cluster-effects (adjusted mean difference -0.03 (95% CI -0.15; 0.09, p = 0.607). Of the secondary outcome measures, BMI and cholesterol were significantly reduced in the intervention group compared to controls in ITT after adjustments (-0.53 kg/m²; 95% CI -1.03;-0.02; p = 0.014 and -0.10 mmol/l; 95% CI -0.21; -0.003; p = 0.043). Additionally, more patients received patient education (49.5% vs. 20.1%, p < 0.0001), eye

  5. Association of Type 2 Diabetes Susceptibility Loci With One-Year Weight Loss in the Look AHEAD Clinical Trial

    PubMed Central

    Peter, Inga; McCaffery, Jeanne M.; Kelley-Hedgepeth, Alyson; Hakonarson, Hakon; Reis, Steven; Wagenknecht, Lynne E.; Kopin, Alan S.; Huggins, Gondon S.

    2012-01-01

    The importance of lifestyle intervention for the prevention and treatment of type 2 diabetes (T2D) has been underscored by the limited benefit of pharmacologic therapies. We sought to determine whether genetic variants that contribute to T2D risk modify the response of weight and waist circumference to an intensive lifestyle intervention (ILI) in patients with obesity and T2D. Look AHEAD (Action for Health in Diabetes) is a randomized clinical trial comparing an ILI with a control condition on the risk of cardiovascular disease in overweight adults with T2D. We analyzed 28 single-nucleotide polymorphisms (SNPs) at/near 17 T2D-susceptibility genes in 3,903 consented participants. We genetically characterized the cohort by assessing whether T2D-susceptibility loci were overrepresented compared with a nondiabetic community-based cohort (N = 1,016). We evaluated the association of individual variants and a composite genetic risk score (GRS) with anthropometric traits at baseline and after 1-year of intervention. Look AHEAD subjects carried more T2D-susceptibility alleles than the control population. At baseline, TCF7L2 risk alleles and the highest GRS were associated with lower BMI and waist circumference. Nominally significant genotype-by-intervention interactions were detected for 1-year change in waist circumference with JAZF1, MTNR1B, and IRS1, and BMI with JAZF1. Highest GRS was associated with a greater reduction in waist circumference at year 1, although the variance in change attributable to the GRS was small. This study shows that the genetic burden associated with T2D risk does not undermine the effect of lifestyle intervention and suggests the existence of additional genomic regions, distinct from the T2D-susceptibility loci, which may enhance or mitigate weight loss. PMID:22307069

  6. A Randomized Controlled Trial Translating the Diabetes Prevention Program to a University Worksite, Ohio, 2012–2014

    PubMed Central

    Weinhold, Kellie R.; Marrero, David G.; Nagaraja, Haikady N.; Focht, Brian C.; Gascon, Gregg M.

    2015-01-01

    Introduction Working adults spend much time at the workplace, an ideal setting for wellness programs targeting weight loss and disease prevention. Few randomized trials have evaluated the efficacy of worksite diabetes prevention programs.This study evaluated the efficacy of a worksite lifestyle intervention on metabolic and behavioral risk factors compared with usual care. Methods A pretest–posttest control group design with 3-month follow-up was used. Participants with prediabetes were recruited from a university worksite and randomized to receive a 16-week lifestyle intervention (n = 35) or usual care (n = 34). Participants were evaluated at baseline, postintervention, and 3-month follow-up. Dietary intake was measured by a food frequency questionnaire and level of physical activity by accelerometers. Repeated measures analysis of variance compared the change in outcomes between and within groups. Results Mean (standard error [SE]) weight loss was greater in the intervention (−5.5% [0.6%]) than in the control (−0.4% [0.5%]) group (P < .001) postintervention and was sustained at 3-month follow-up (P < .001). Mean (SE) reductions in fasting glucose were greater in the intervention (−8.6 [1.6] mg/dL) than in the control (−3.7 [1.6] mg/dL) group (P = .02) postintervention; both groups had significant glucose reductions at 3-month follow-up (P < .001). In the intervention group, the intake of total energy and the percentage of energy from all fats, saturated fats, and trans fats decreased, and the intake of dietary fiber increased (all P < .01) postintervention. Conclusion The worksite intervention improved metabolic and behavioral risk factors among employees with prediabetes. The long-term impact on diabetes prevention and program sustainability warrant further investigation. PMID:26605710

  7. Effect of various doses of vitamin D supplementation on pregnant women with gestational diabetes mellitus: A randomized controlled trial

    PubMed Central

    Zhang, Qingying; Cheng, Yan; He, Mulan; Li, Tingting; Ma, Ziwen; Cheng, Haidong

    2016-01-01

    It has previously been reported that the influence of vitamin D on the metabolism of calcium and phosphorus is associated with diabetes, cardiovascular disease, Alzheimer's disease, cancer and other systemic diseases, and is considered an important indicator of general health. The present study was conducted to determine the effect of various doses of vitamin D supplementation on glucose metabolism, lipid concentrations, inflammation and the levels of oxidative stress of pregnant women with gestational diabetes mellitus (GDM). The present randomized, double-blind placebo-controlled clinical trial was conducted on 133 pregnant women with GDM during weeks 24–28 of pregnancy. The patients were randomly divided into four groups. The control group (n=20) received a placebo (sucrose; one granule/day), the low dosage group (n=38) received the daily recommended intake of 200 IU vitamin D (calciferol) daily, the medium dosage group (n=38) received 50,000 IU monthly (2,000 IU daily for 25 days) and the high dosage group (n=37) received 50,000 IU every 2 weeks (4,000 IU daily for 12.5 days). The general characteristics and dietary intakes of the patients with GDM were similar between each group. Using ELISA kits, it was determined that insulin, homeostatic model assessment-insulin resistance and total cholesterol were significantly reduced by high dosage vitamin D supplementation (P<0.05). Total antioxidant capacity and total glutathione levels were significantly elevated as a result of high dosage vitamin D supplementation (P<0.01). In conclusion, high-dose vitamin D supplementation (50,000 IU every 2 weeks) significantly improved insulin resistance in pregnant women with GDM. PMID:27588106

  8. Cost-Effectiveness of Bariatric Surgery for Type 2 Diabetes Mellitus: A Randomized Controlled Trial in China.

    PubMed

    Tang, Qi; Sun, Zhipeng; Zhang, Nengwei; Xu, Guangzhong; Song, Peipei; Xu, Lingzhong; Tang, Wei

    2016-05-01

    To compare the remission of type 2 diabetes mellitus (T2DM) through treatment with laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB), and to analyze the cost-effectiveness of medical treatment, LSG, and LRYGB in T2DM patients (BMI ≥ 28).A 2-group randomized controlled trial was conducted at Diabetes Surgery Centre, Beijing Shijitan Hospital in Beijing, China. Subjects were 80 patients ages 16 to 65 years with a body mass index of 28 kg/m or more and duration of T2DM no more than 15 years. Subjects were randomly assigned (1:1) to undergo either LSG (n = 40) or LRYGB (n = 40) between February 3, 2011 and October 31, 2013. Of those patients, 72 (90%) were available at follow-up at 2 years. These patients included 34 (85%) who underwent LSG and 38 (95%) who underwent LRYGB. This study presents the follow-up data at 2 years, which compared LSG and LRYGB in T2DM patients. Partial remission and complete remission were determined, and weight loss, BMI, changes in abdominal circumference, cholesterol, and triglycerides were measured. The cost-effectiveness of each type of bariatric surgery was analyzed with a Markov simulation model that yielded quality-adjusted life-years (QALYs) and costs.From our analysis results, LSG and LRYGB are both have taken a great effect on the reduction of fasting plasma glucose (FPG), hemoglobin A1c (HbA1c), and bodyweight in patients with T2DM. The cost-effectiveness ratios of medical treatment, LSG, and LRYGB respectively are 1589.02, 1028.97, and 1197.44 dollars per QALY.Our analysis indicates that LSG appear to provide a cost-effective method of T2DM treatment for the patients. PMID:27196454

  9. Intensive Weight Loss Intervention in Individuals Ages 65 Years or Older: Results from the Look AHEAD Type 2 Diabetes Trial

    PubMed Central

    Espeland, Mark A.; Rejeski, W. Jack; West, Delia S.; Bray, George A.; Clark, Jeanne M.; Peters, Anne L.; Chen, Haiying; Johnson, Karen C.; Horton, Edward S.; Hazuda, Helen P.

    2013-01-01

    OBJECTIVES To compare the relative effects of four years of intensive lifestyle intervention on weight, fitness, and cardiovascular disease risk factors among older versus younger individuals DESIGN A randomized controlled clinical trial SETTING 16 US clinical sites PARTICIPANTS Individuals with type 2 diabetes: 1,053 aged 65–76 years and 4,092 aged 45–64 years INTERVENTIONS An intensive behavioral intervention designed to promote and maintain weight loss through caloric restriction and increased physical activity compared to a condition of diabetes support and education. MEASUREMENTS Standardized assessments of weight, fitness (based on graded exercise testing), and cardiovascular disease risk factors RESULTS Across four years, older individuals had greater intervention-related mean weight losses than younger participants, 6.2% versus 5.1% (interaction p=0.006) and comparable relative mean increases in fitness, 0.56 versus 0.53 metabolic equivalents (interaction p=0.72). These benefits were seen consistently across subgroups of older adults formed by many demographic and health factors. Among a panel of age-related health conditions, only self-reported worsening vision was associated with poorer intervention-related weight loss in older individuals. The intensive lifestyle intervention produced mean increases in high density lipoprotein cholesterol (2.03 mg/dl; p<0.001) and decreases in glycated hemoglobin (0.21%; p<0.001) and waist girth (3.52 cc; p<0.001) across 4 years that were at least as large in older compared to younger individuals. CONCLUSION Intensive lifestyle intervention targeting weight loss and increased physical activity is effective in overweight and obese older individuals to produce sustained weight loss and improvements in fitness and cardiovascular risk factors. PMID:23668423

  10. Association of type 2 diabetes susceptibility loci with one-year weight loss in the look AHEAD clinical trial.

    PubMed

    Peter, Inga; McCaffery, Jeanne M; Kelley-Hedgepeth, Alyson; Hakonarson, Hakon; Reis, Steven; Wagenknecht, Lynne E; Kopin, Alan S; Huggins, Gondon S

    2012-08-01

    The importance of lifestyle intervention for the prevention and treatment of type 2 diabetes (T2D) has been underscored by the limited benefit of pharmacologic therapies. We sought to determine whether genetic variants that contribute to T2D risk modify the response of weight and waist circumference to an intensive lifestyle intervention (ILI) in patients with obesity and T2D. Look AHEAD (Action for Health in Diabetes) is a randomized clinical trial comparing an ILI with a control condition on the risk of cardiovascular disease in overweight adults with T2D. We analyzed 28 single-nucleotide polymorphisms (SNPs) at/near 17 T2D-susceptibility genes in 3,903 consented participants. We genetically characterized the cohort by assessing whether T2D-susceptibility loci were overrepresented compared with a nondiabetic community-based cohort (N = 1,016). We evaluated the association of individual variants and a composite genetic risk score (GRS) with anthropometric traits at baseline and after 1-year of intervention. Look AHEAD subjects carried more T2D-susceptibility alleles than the control population. At baseline, TCF7L2 risk alleles and the highest GRS were associated with lower BMI and waist circumference. Nominally significant genotype-by-intervention interactions were detected for 1-year change in waist circumference with JAZF1, MTNR1B, and IRS1, and BMI with JAZF1. Highest GRS was associated with a greater reduction in waist circumference at year 1, although the variance in change attributable to the GRS was small. This study shows that the genetic burden associated with T2D risk does not undermine the effect of lifestyle intervention and suggests the existence of additional genomic regions, distinct from the T2D-susceptibility loci, which may enhance or mitigate weight loss. PMID:22307069

  11. Effects of pomegranate juice consumption on inflammatory markers in patients with type 2 diabetes: A randomized, placebo-controlled trial

    PubMed Central

    Sohrab, Golbon; Nasrollahzadeh, Javad; Zand, Hamid; Amiri, Zohreh; Tohidi, Maryam; Kimiagar, Masoud

    2014-01-01

    Background: Diabetes causes the increased concentration of circulatory cytokines as a result of inflammation. Considering that pomegranate juice (PJ) is known to have antioxidant and anti-inflammatory properties, the purpose of this study was to determine the effects of PJ consumption on markers of inflammation in patients with type 2 diabetes (T2D). Materials and Methods: In a randomized, double-blind clinical trial study, 50 patients with T2D (40-65 years old) were randomly assigned to one of two groups. Participants in each group received either 250 mL/day PJ or a control beverage for 12 weeks. Biochemical markers including fasting plasma glucose (FPG), insulin and inflammatory markers were assayed on the baseline and follow-up blood samples. Results: In all, 44 patients in two groups were included in the analysis: PJ (n = 22) and placebo (n = 22). After 12 weeks of intervention, in the PJ group, there were 32% and 30% significant decreases in plasma C-reactive protein (hs-CRP) and Interlukin-6, respectively (P < 0.05). The mean ± SD plasma interlukin-6 (7.1 ± 5.6 vs. 11.9 ± 14.4 mg/L) and hs-CRP (1791 ± 1657 and 1953 ± 1561 ng/mL) concentrations in the PJ group were significantly lower than the placebo group after intervention (P < 0.05). Conclusion: PJ consumption by patients with T2D does not affect FPG or the insulin resistance index (HOMA-IR), whereas it does reduce Interlukin-6 and hs-CRP concentrations in plasma. Therefore, PJ consumption may have an anti-inflammatory effect in patients with T2D. PMID:24949028

  12. A Randomized Cross-Over Trial of the Postprandial Effects of Three Different Diets in Patients with Type 2 Diabetes

    PubMed Central

    Bunjaku, Bekim; Rosenqvist, Ulf; Nystrom, Fredrik H.; Guldbrand, Hans

    2013-01-01

    Background In the clinic setting both fasting levels of glucose and the area under the curve (AUC) of glucose, by determination of HbA1c levels, are used for risk assessments, in type 2 diabetes (NIDDM). However little is known about postprandial levels, and hence AUC, regarding other traditional risk factors such as insulin and blood-lipids and how this is affected by different diets. Objective To study postprandial effects of three diets, during a single day, in NIDDM. Methods A low-fat diet (45–56 energy-% from carbohydrates), and a low-carbohydrate diet (16–24 energy-% from carbohydrates) was compared with a Mediterranean-style diet (black coffee for breakfast and the same total-caloric intake as the other two diets for lunch with red wine, 32–35 energy−% from carbohydrates) in a randomized cross-over design. Total-caloric intake/test-day at the clinic from food was 1025–1080 kCal in men and 905–984 kCal in women. The test meals were consumed at a diabetes ward under supervision. Results Twenty-one participants were recruited and 19 completed the studies. The low-carbohydrate diet induced lower insulin and glucose excursions compared with the low-fat diet (p<0.0005 for both AUC). The insulin-response following the single Mediterranean-style lunch-meal was more pronounced than during the low-fat diet lunch (insulin increase-ratio of the low-fat diet: 4.35±2.2, of Mediterranean-style diet: 8.12±5.2, p = 0.001) while postprandial glucose levels were similar. The increase-ratio of insulin correlated with the elevation of the incretin glucose-dependent insulinotropic-polypeptide following the Mediterranean-style diet lunch (Spearman, r = 0.64, p = 0.003). Conclusions The large Mediterranean-style lunch-meal induced similar postprandial glucose-elevations as the low-fat meal despite almost double amount of calories due to a pronounced insulin-increase. This suggests that accumulation of caloric intake from breakfast and lunch to a single

  13. After the diabetes care trial ends, now what? A 1-year follow-up of the RxING study

    PubMed Central

    Al Hamarneh, Yazid N; Sauriol, Luc; Tsuyuki, Ross T

    2015-01-01

    Introduction There is strong evidence that pharmacist care improves patients’ glycaemic control. However, the sustainability and durability of such interventions beyond the research period is not known. RxING was the first trial of pharmacist prescribing in diabetes and it showed an improvement in glycated haemoglobin (HbA1c) of 1.8% over 6 months. Objective 1° objective: To evaluate glycaemic control in the RxING study patients 12 months after the end of the formal study follow-up. 2° objective: To assess the patients’ risk of cardiovascular events in the next 10 years. Methods We contacted the participating pharmacists to check if the patients who participated in the RxING study are still taking insulin, the dose of insulin they are taking, and their HbA1c. There were no mandated follow-up visits with the pharmacist after the study completion. Results A total of 100 patients with poorly controlled type 2 diabetes were enrolled in the original RxING study; 93 of them completed the study, while 83 participated in the 12-month follow-up. Seventy-five patients were still taking insulin, with the average dose increasing from 31.1 units (SD 18.4) at study completion to 37.4 units (SD 30.8) (95% CI −13.3 to 0.88, p=0.085). HbA1c was reduced from 9.1% (SD 1) at baseline to 7.3% (SD 0.9) at study completion (95% CI 1.4 to 2, p <0.001), and increased to 8.1% (SD 1.3) 12 months later (95% CI −1.1 to −0.5, p <0.001 vs study completion). Conclusions Twelve months after completing the intervention, approximately half of the glycaemic control gains were lost. This highlights the importance of structured follow-up with the pharmacist in this patient population. Trial registration number clinicaltrials.gov; Identifier: NCT01335763. PMID:26270946

  14. Liraglutide's Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Pediatric Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Trial

    PubMed Central

    Battelino, Tadej; Chatterjee, D.J.; Jacobsen, Lisbeth V.; Hale, Paula M.; Arslanian, Silva

    2014-01-01

    Abstract Background: The prevalence of type 2 diabetes (T2D) in youth is increasing. Treatment options beyond metformin and insulin are needed. The safety, tolerability, pharmacokinetics, and pharmacodynamics of liraglutide once daily in youth (10–17 years old) with T2D were investigated in a randomized, double-blind, placebo-controlled trial. Subjects and Methods: Youth treated with diet/exercise alone or with metformin and having a hemoglobin A1c (HbA1c) level of 6.5–11% were randomized to liraglutide (n=14) or placebo (n=7). Starting at 0.3 mg/day, doses were escalated weekly to 0.6, 0.9, 1.2, and 1.8 mg/day (or placebo equivalent) for 5 weeks. Results: Nineteen participants completed the trial. Baseline characteristics were similar between groups, with mean (SD) values for age of 14.8 (2.2) years, weight of 113.2 (35.6) kg (range, 57–214 kg), diabetes duration of 1.7 (1.4) years, and HbA1c level of 8.1% (1.2%). No serious adverse events (AEs), including severe hypoglycemia, occurred. Transient gastrointestinal AEs were most common at lower liraglutide doses during dose escalation. No significant changes in safety and tolerability parameters occurred. There was no evidence of pancreatitis or lipase elevations above three times the upper normal limit; calcitonin levels remained within the normal range. For liraglutide 1.8 mg, mean half-life was 12 h, and clearance was 1.7 L/h. After 5 weeks, the decline in HbA1c level was greater with liraglutide versus placebo (−0.86 vs. 0.04%, P=0.0007), whereas mean body weight remained stable (−0.50 vs. −0.54 kg, P=0.9703). Conclusions: Liraglutide was well tolerated in youth with T2D, with safety, tolerability, and pharmacokinetic profiles similar to profiles in adults. PMID:25036533

  15. Data-Driven Personalized Feedback to Patients with Type 1 Diabetes: A Randomized Trial

    PubMed Central

    Årsand, Eirik; Godtliebsen, Fred; Joakimsen, Ragnar M.

    2015-01-01

    Abstract Background: A mobile phone-based application can be useful for patients with type 1 diabetes in managing their disease. This results in large datasets accumulated on the patient's devices, which can be used for individualized feedback. The effect of such feedback is investigated in this article. Materials and Methods: We developed an application that included a data-driven feedback module known as Diastat for patients on self-measured blood glucose regimens. Using a stepped-wedge design, both groups initially received an application without Diastat. Group 1 activated Diastat after 4 weeks, whereas Group 2 activated Diastat 12 weeks after startup (T1). End points were glycated hemoglobin (HbA1c) level and number of out-of-range (OOR) measurements (i.e., outside the range 72–270 mg/dL). Results: Thirty patients were recruited to the study, and 15 were assigned to each group after the initial meeting. There were no significant differences between groups at T1 in HbA1c or OOR events. Overall, all patients had a decrease of 0.6 percentage points in mean HbA1c (P<0.001) and 14.5 in median OOR events over 2 weeks (P<0.001). Conclusions: The study does not provide evidence that data-driven feedback improves glycemic control. The decrease in HbA1c was sizeable and significant, even though the study was not powered to detect this. The overall improvement in glycemic control suggests that, in general, mobile phone-based interventions can be useful in diabetes self-management. PMID:25751133

  16. Telemedicine Versus Standard Follow-Up Care for Diabetes-Related Foot Ulcers: Protocol for a Cluster Randomized Controlled Noninferiority Trial (DiaFOTo)

    PubMed Central

    Espehaug, Birgitte; Hausken, Marie F; Graue, Marit; Østbye, Truls; Skeie, Svein; Cooper, John G; Tell, Grethe S; Günther, Bodo Erhardt; Dale, Håvard; Smith-Strøm, Hilde; Kolltveit, Beate-Christin H; Kirkevold, Marit; Rokne, Berit

    2016-01-01

    Background This paper presents the protocol for an ongoing study to evaluate a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. Diabetes-related foot ulcers represent challenges for patients and the health services. The large increase in the prevalence of diabetes, combined with the aging population, means that the absolute number of patients with diabetes-related foot ulcers is likely to continue to increase. Health care services therefore need to provide close clinical follow-up care for people with diabetes both in primary and specialist care. Information and communication technologies may enable more integrated treatment and care pathways across organizational boundaries. However, we lack knowledge about the effect of telemedicine follow-up and how such services can be optimally organized. Objective To present the design and methods of a study evaluating a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. Methods The study is designed as a cluster randomized controlled trial (noninferiority trial) involving municipalities or municipality districts (clusters) belonging to one clinical site in Western Norway. The study includes patients with type 1 and type 2 diabetes presenting with a new foot ulcer at the initial visit to the clinic. Patients in the intervention group receive telemedicine follow-up care in the community. The key ingredient in the intervention is the close integration between health care levels. The intervention is facilitated by the use of an interactive wound platform consisting of a Web-based ulcer record combined with a mobile phone, enabling counseling and communication between nurses in the community and specialist health care. Patients in the control group receive standard hospital outpatient care. The primary endpoint in the trial is healing time; secondary outcomes include amputation and death, patient-reported outcome measures, and follow-up data on the recurrence of

  17. Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial – study protocol

    PubMed Central

    2014-01-01

    Background Diabetes and obesity have reached epidemic proportions in the U.S. with rates consistently higher among Hispanics as compared to non-Hispanic whites. Among Hispanic women diagnosed with gestational diabetes mellitus (GDM), 50% will go on to develop type 2 diabetes within 5 years of the index pregnancy. Although randomised controlled trials among adults with impaired glucose tolerance have shown that diet and physical activity reduce the risk of type 2 diabetes, such programs have not been tested in high-risk postpartum women. The overall goal of this randomised controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy. Methods/Design Hispanic pregnant women who screen positive for GDM will be recruited and randomly assigned to a Lifestyle Intervention (n = 150) or a Health & Wellness (control) Intervention (n = 150). Multimodal contacts (i.e., in-person, telephone, and mailed materials) will be used to deliver the intervention from late pregnancy (29 weeks gestation) to 12 months postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses the specific cultural and environmental challenges faced by low-income Hispanic women. Assessments will be conducted at enrollment, and at 6-weeks, 6-months, and 12-months postpartum by trained bicultural and bilingual personnel blinded to the intervention arm. Efficacy will be assessed via postpartum weight loss and biomarkers of insulin resistance and cardiovascular risk. Changes in

  18. Design of a trial to evaluate the impact of clinical pharmacists and community health promoters working with African-Americans and Latinos with Diabetes

    PubMed Central

    2012-01-01

    Background Given the increasing prevalence of diabetes and the lack of patients reaching recommended therapeutic goals, novel models of team-based care are emerging. These teams typically include a combination of physicians, nurses, case managers, pharmacists, and community-based peer health promoters (HPs). Recent evidence supports the role of pharmacists in diabetes management to improve glycemic control, as they offer expertise in medication management with the ability to collaboratively intensify therapy. However, few studies of pharmacy-based models of care have focused on low income, minority populations that are most in need of intervention. Alternatively, HP interventions have focused largely upon low income minority groups, addressing their unique psychosocial and environmental challenges in diabetes self-care. This study will evaluate the impact of HPs as a complement to pharmacist management in a randomized controlled trial. Methods/Design The primary aim of this randomized trial is to evaluate the effectiveness of clinical pharmacists and HPs on diabetes behaviors (including healthy eating, physical activity, and medication adherence), hemoglobin A1c, blood pressure, and LDL-cholesterol levels. A total of 300 minority patients with uncontrolled diabetes from the University of Illinois Medical Center ambulatory network in Chicago will be randomized to either pharmacist management alone, or pharmacist management plus HP support. After one year, the pharmacist-only group will be intensified by the addition of HP support and maintenance will be assessed by phasing out HP support from the pharmacist plus HP group (crossover design). Outcomes will be evaluated at baseline, 6, 12, and 24 months. In addition, program and healthcare utilization data will be incorporated into cost and cost-effectiveness evaluations of pharmacist management with and without HP support. Discussion The study will evaluate an innovative, integrated approach to chronic disease

  19. Autonomous exercise game use improves metabolic control and quality of life in type 2 diabetes patients - a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Lifestyle intervention in type 2 diabetes mellitus (T2DM) is effective but needs a special local setting and is costly. Therefore, in a randomized-controlled trial we tested the hypothesis that the autonomous use of the interactive exercise game Wii Fit Plus over a period of 12 weeks improves metabolic control, with HbA1c reduction as the primary outcome, and weight loss, reduction of cardiometabolic risk factors, physical activity and quality of life (secondary outcomes) in T2DM patients. Methods Participants (n = 220) were randomized into an intervention and a control group. The intervention group was provided with a Wii console, a balance board and the exercise game Wii Fit Plus for 12 weeks. The control group remained under routine care and received the items 12 weeks later. At baseline and after 12 weeks (and for the control group additionally after 12 weeks of intervention) the participants’ health parameters, medication, physical activity and validated questionnaires for quality of life (PAID, SF12, WHO-5, CES-D) were requested and compared in a complete case analysis using the Mann–Whitney test and the Wilcoxon signed rank test. Results 80% of participants completed the 12-week study. Patients in the intervention group significantly improved HbA1c (from 7.1 ± 1.3% to 6.8 ± 0.9%; -0.3 ± 1.1%; p = 0.0002) in comparison to the control group (from 6.8 ± 0.9% to 6.7 ± 0.7%; -0.1 ± 0.5%) and also significantly reduced fasting blood glucose (from 135.8 ± 38.9 mg/dl to 126.6 ± 36.6 mg/dl; p = 0.04), weight (from 97.6 ± 19.2 kg to 96.3 ± 18.7 kg; p < 0.001) and body mass index (from 34.1 ± 6.5 kg/m2 to 33.5 ± 6.5 kg/m2; p < 0.001). Daily physical activity increased significantly (p < 0.001). Diabetes-dependent impairment, mental health, subjective wellbeing and quality of life also improved significantly, and the number of patients with depression decreased

  20. Effectiveness of the Austrian disease-management-programme for type 2 diabetes: study protocol of a cluster-randomized controlled trial

    PubMed Central

    Sönnichsen, Andreas C; Rinnerberger, Andreas; Url, Maria G; Winkler, Henrike; Kowatsch, Peter; Klima, Gert; Fürthauer, Bernhard; Weitgasser, Raimund

    2008-01-01

    Background Due to its rising prevalence type 2 diabetes plays an important role concerning population health in Austria and other western countries. In various studies deficiencies in the care of diabetic patients have been revealed. These deficiencies may be overcome by disease-management-programmes (DMPs), but international experience shows that the effectiveness of DMPs is inconsistent. In particular large programmes designed by state-affiliated public health insurances have not been evaluated in randomized controlled trials (RCTs). We are therefore conducting a large scale RCT of the Austrian DMP for type 2 diabetic patients in the province of Salzburg to evaluate the programme regarding its effects on metabolic control, guideline adherent care and the quality of life of diabetic patients. Methods/Design The study is open for participation to all GPs and internists in the province of Salzburg. Physicians are randomized before recruitment of patients with the districts of Salzburg as clusters of randomisation. A total of over 1200 patients with type 2 diabetes will then be recruited. In the intervention group the DMP is applied for one year. Controls receive usual care. Endpoints are a decrease in HbA1c in the intervention group > 0,5% compared to controls, a higher percentage of patients with required diagnostic measures according to guidelines, improved cardiovascular risk profile and higher quality of life scores within one year. Current status of the study 98 Physicians agreed to participate in the study. 96 of them recruited 1494 patients, 654 in the intervention and 840 in the control group. Trail Registration This trial has been registered with Current Controlled Trials Ltd. (ISRCTN27414162). PMID:18565213

  1. The effect of the macrobiotic Ma-Pi 2 diet vs. the recommended diet in the management of type 2 diabetes: the randomized controlled MADIAB trial

    PubMed Central

    2014-01-01

    Background Diet is an important component of type 2 diabetes therapy. Low adherence to current therapeutic diets points out to the need for alternative dietary approaches. This study evaluated the effect of a different dietary approach, the macrobiotic Ma-Pi 2 diet, and compared it with standard diets recommended for patients with type 2 diabetes. Methods A randomized, controlled, open-label, 21-day trial was undertaken in patients with type 2 diabetes comparing the Ma-Pi 2 diet with standard (control) diet recommended by professional societies for treatment of type 2 diabetes. Changes in fasting blood glucose (FBG) and post-prandial blood glucose (PPBG) were primary outcomes. HbA1c, insulin resistance (IR), lipid panel and anthropometrics were secondary outcomes. Results After correcting for age, gender, BMI at baseline, and physical activity, there was a significantly greater reduction in the primary outcomes FBG (95% CI: 1.79; 13.46) and PPBG (95% CI: 5.39; 31.44) in those patients receiving the Ma-Pi 2 diet compared with those receiving the control diet. Statistically significantly greater reductions in the secondary outcomes, HbA1c (95% CI: 1.28; 5.46), insulin resistance, total cholesterol, LDL cholesterol and LDL/HDL ratio, BMI, body weight, waist and hip circumference were also found in the Ma-Pi 2 diet group compared with the control diet group. The latter group had a significantly greater reduction of triglycerides compared with the Ma-Pi 2 diet group. Conclusions Intervention with a short-term Ma-Pi 2 diet resulted in significantly greater improvements in metabolic control in patients with type 2 diabetes compared with intervention with standard diets recommended for these patients. Trial registration Current Controlled Trials ISRCTN10467793. PMID:25302069

  2. Effects of combination of perindopril, indapamide, and calcium channel blockers in patients with type 2 diabetes mellitus: results from the Action In Diabetes and Vascular Disease: Preterax and Diamicron Controlled Evaluation (ADVANCE) trial.

    PubMed

    Chalmers, John; Arima, Hisatomi; Woodward, Mark; Mancia, Giuseppe; Poulter, Neil; Hirakawa, Yoichiro; Zoungas, Sophia; Patel, Anushka; Williams, Bryan; Harrap, Stephen

    2014-02-01

    The objective of the present analysis was to determine the effects of a fixed combination of perindopril and indapamide in combination with calcium channel blockers (CCBs) in patients with type 2 diabetes mellitus. The Action in Diabetes and Vascular Disease: Preterax and Diamicron Controlled Evaluation (ADVANCE) trial was a factorial randomized controlled trial. A total of 11 140 patients with type 2 diabetes mellitus were randomly assigned to fixed combination of perindopril-indapamide (4/1.25 mg) or placebo. Effects of randomized treatment on mortality and major cardiovascular outcomes were examined in subgroups defined by baseline use of CCBs. Patients on CCB at baseline (n=3427) constituted a higher risk group compared with those not on CCB (n=7713), with more extensive use of antihypertensive and other protective therapies. Active treatment reduced the relative risk of death by 28% (95% confidence interval, 10%-43%) among patients with CCB at baseline compared with 5% (-12% to 20%) among those without CCB (P homogeneity=0.02) and 14% (2%-25%) for the whole population. Similarly, the relative risk reduction for major cardiovascular events was 12% (-8% to 28%) versus 6% (-10% to 19%) for those with and without CCB at baseline although the difference was not statistically significant (P homogeneity=0.38). There was no detectable increase in adverse effects in those receiving CCB. The combination of perindopril and indapamide with CCBs seems to provide further protection against mortality in patients with type 2 diabetes mellitus. PMID:24324048

  3. Favorable effects of vitamin D supplementation on pregnancy outcomes in gestational diabetes: a double blind randomized controlled clinical trial.

    PubMed

    Asemi, Z; Karamali, M; Esmaillzadeh, A

    2015-07-01

    Gestational diabetes mellitus (GDM) has been recognized as a significant risk factor for unfavorable pregnancy outcomes. Prevalence of vitamin D deficiency is highly prevalent among women with GDM. This study was designed to assess the effect of vitamin D supplementation on pregnancy outcomes of pregnant women with GDM who were not on oral hypoglycemic agents. This randomized controlled clinical trial was performed among 45 pregnant women diagnosed with GDM at 24-28 weeks' gestation. Subjects were randomly assigned to consume either vitamin D supplements (cholecalciferol) or placebo. Individuals in the vitamin D group (n=22) received 50 000 IU vitamin D3 pearl 2 times during the study: at study baseline and day 21 of intervention and those in placebo group (n=23) received 2 placebos at the mentioned times. Fasting blood samples were taken at baseline to measure fasting plasma glucose. Participants underwent a 3-h oral glucose tolerance tests (OGTT) and the blood samples were collected at time 60, 120, and 180 min to measure plasma glucose levels. Newborn's weight, height, head circumference, Apgar score, and hyperbilirubinemia were determined. Taking vitamin D supplements, compared with placebo, resulted in improved pregnancy outcomes; such that those in the vitamin D group had no case of polyhydramnios, while 17.4% of subjects in placebo group had this condition (p=0.04). In addition, newborn's hyperbilirubinemia was significantly lower in vitamin D group than that in placebo group (27.3% vs. 60.9%, p=0.02). In conclusion, vitamin D supplementation for 6 weeks among pregnant women with GDM resulted in decreased maternal polyhydramnios and infant hyperbilirubinemia compared with placebo. Clinical trial registration number www.irct.ir:IRCT201305115623N7. PMID:25372774

  4. The need for a large-scale trial of fibrate therapy in diabetes: the rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. [ISRCTN64783481

    PubMed Central

    2004-01-01

    Background Fibrates correct the typical lipid abnormalities of type 2 diabetes mellitus, yet no study, to date, has specifically set out to evaluate the role of fibrate therapy in preventing cardiovascular events in this setting. Methods Subjects with type 2 diabetes, aged 50–75 years, were screened for eligibility to participate in a long-term trial of comicronized fenofibrate 200 mg daily compared with matching placebo to assess benefits of treatment on the occurrence of coronary and other vascular events. People with total cholesterol levels 3.0–6.5 mmol/L plus either a total-to-HDLc ratio >4.0 or triglyceride level >1.0 mmol/L with no clear indication for lipid-modifying therapy were eligible. Results A total of 9795 people were randomized into the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial. All received dietary advice, followed by a 6-week single-blind placebo run-in, then a 6-week active run-in period before randomization. Participants are being followed up every 6 months for outcome events and safety assessments. The study is designed to yield at least 500 coronary events (primary endpoint: first nonfatal myocardial infarction or coronary death) over 5 years, to have 80% power to identify as statistically significant at 2P = 0.05 a 22% reduction in such events, using intention-to-treat methods. Conclusions Type 2 diabetes is the most common endocrine disorder worldwide, and its prevalence is increasing. The current evidence about use of fibrates in type 2 diabetes, from around 2000 people treated, will increase with FIELD to evidence from around 12000. FIELD will establish the role of fenofibrate treatment in reducing cardiovascular risk in people with type 2 diabetes. The main results are expected to be available in late 2005. PMID:15571637

  5. Progression of Carotid Artery Intima-Media Thickness During 12 Years in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study

    PubMed Central

    Polak, Joseph F.; Backlund, Jye-Yu C.; Cleary, Patricia A.; Harrington, Anita P.; O’Leary, Daniel H.; Lachin, John M.; Nathan, David M.

    2011-01-01

    OBJECTIVE This study investigated the long-term effects of intensive diabetic treatment on the progression of atherosclerosis, measured as common carotid artery intima-media thickness (IMT). RESEARCH DESIGN AND METHODS A total of 1,116 participants (52% men) in the Epidemiology of Diabetes Interventions and Complications (EDIC) trial, a long-term follow-up of the Diabetes Control and Complications Trial (DCCT), had carotid IMT measurements at EDIC years 1, 6, and 12. Mean age was 46 years, with diabetes duration of 24.5 years at EDIC year 12. Differences in IMT progression between DCCT intensive and conventional treatment groups were examined, controlling for clinical characteristics, IMT reader, and imaging device. RESULTS Common carotid IMT progression from EDIC years 1 to 6 was 0.019 mm less in intensive than in conventional (P < 0.0001), and from years 1 to 12 was 0.014 mm less (P = 0.048); but change from years 6 to 12 was similar (intensive − conventional = 0.005 mm, P = 0.379). Mean A1C levels during DCCT and DCCT/EDIC were strongly associated with progression of IMT, explaining most of the differences in IMT progression between DCCT treatment groups. Albuminuria, older age, male sex, smoking, and higher systolic blood pressure were significant predictors of IMT progression. CONCLUSIONS Intensive treatment slowed IMT progression for 6 years after the end of DCCT but did not affect IMT progression thereafter (6–12 years). A beneficial effect of prior intensive treatment was still evident 13 years after DCCT ended. These differences were attenuated but not negated after adjusting for blood pressure. These results support the early initiation and continued maintenance of intensive diabetes management in type 1 diabetes to retard atherosclerosis. PMID:21270271

  6. Understanding experiences of participating in a weight loss lifestyle intervention trial: a qualitative evaluation of South Asians at high risk of diabetes

    PubMed Central

    Morrison, Zoe; Douglas, Anne; Bhopal, Raj; Sheikh, Aziz

    2014-01-01

    Objective To explore the reasons for enrolling, experiences of participating and reasons for remaining in a family-based, cluster randomised controlled trial of a dietitian-delivered lifestyle modification intervention aiming to reduce obesity in South Asians at high risk of developing diabetes. Design Qualitative study using narrative interviews of a purposive sample of trial participants following completion of the intervention. Data were thematically analysed. Setting The intervention was conducted in Scotland and resulted in a modest decrease in weight, but did not statistically reduce the incidence of diabetes. Participants We conducted 21 narrative interviews with 24 participants (20 trial participants and four family volunteers). Results Many participants were motivated to participate because of: known family history of diabetes and the desire to better understand diabetes-related risks to their own and their family's health; ways to mitigate these risks and to benefit from personalised monitoring. Home-based interventions, communication in the participant's chosen language(s) and continuity in dietitians supported their continuing engagement with the trial. Adaptations in food choices were initially accommodated by participants, although social and faith-based responsibilities were reported as important barriers to persevering with agreed dietary goals. Many participants reported that increasing their level of physical activity was difficult given their long working hours, physically demanding employment and domestic commitments; this being compounded by Scotland's challenging climate and a related reluctance to exercise in the outdoors. Conclusions Although participants had strong personal interests in participation and found the information provided by dietitians useful, they nonetheless struggled to incorporate the dietary and exercise recommendations into their daily lives. In particular, increasing levels of physical exercise was described as an

  7. A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial

    PubMed Central

    2012-01-01

    Background Neuropathic diabetic foot ulceration may be prevented if the mechanical stress transmitted to the plantar tissues is reduced. Insole therapy is one practical method commonly used to reduce plantar loads and ulceration risk. The type of insole best suited to achieve this is unknown. This trial compared custom-made functional insoles with prefabricated insoles to reduce risk factors for ulceration of neuropathic diabetic feet. Method A participant-blinded randomised controlled trial recruited 119 neuropathic participants with diabetes who were randomly allocated to custom-made functional or prefabricated insoles. Data were collected at issue and six month follow-up using the F-scan in-shoe pressure measurement system. Primary outcomes were: peak pressure, forefoot pressure time integral, total contact area, forefoot rate of load, duration of load as a percentage of stance. Secondary outcomes were patient perceived foot health (Bristol Foot Score), quality of life (Audit of Diabetes Dependent Quality of Life). We also assessed cost of supply and fitting. Analysis was by intention-to-treat. Results There were no differences between insoles in peak pressure, or three of the other four kinetic measures. The custom-made functional insole was slightly more effective than the prefabricated insole in reducing forefoot pressure time integral at issue (27% vs. 22%), remained more effective at six month follow-up (30% vs. 24%, p=0.001), but was more expensive (UK £656 vs. £554, p<0.001). Full compliance (minimum wear 7 hours a day 7 days per week) was reported by 40% of participants and 76% of participants reported a minimum wear of 5 hours a day 5 days per week. There was no difference in patient perception between insoles. Conclusion The custom-made insoles are more expensive than prefabricated insoles evaluated in this trial and no better in reducing peak pressure. We recommend that where clinically appropriate, the more cost effective prefabricated insole

  8. Study design and methods for a randomized crossover trial substituting brown rice for white rice on diabetes risk factors in India

    PubMed Central

    Wedick, Nicole M.; Vasudevan, Sudha; Spiegelman, Donna; Bai, Ramya; Malik, Vasanti; Venkatachalam, Siva Sankari; Parthasarathy, Vijayalaksmi; Vaidya, Ruchi; Nagarajan, Lakshmipriya; Arumugam, Kokila; Jones, Clara; Campos, Hannia; Krishnaswamy, Kamala; Willett, Walter; Hu, Frank B.; Mohan, Anjana Ranjit; Viswanathan, Mohan

    2016-01-01

    India has the second largest number of people with diabetes in the world following China. Evidence indicates that consumption of whole grains can reduce risk of type 2 diabetes. This manuscript describes the study design and methods of a trial in progress evaluating the effects of substituting whole grain brown rice for polished (refined) white rice on biomarkers of diabetes risk (glucose metabolism, dyslipidemia, inflammation). This is a randomized controlled clinical trial with a crossover design conducted in Chennai, India among overweight but otherwise healthy volunteers aged 25–65y with a body mass index ≥23kg/m2 and habitual rice consumption ≥200grams/day. The feasibility and cultural appropriateness of this type of intervention in the local environment will also be examined. If the intervention is efficacious, the findings can be incorporated into national-level policies which could include the provision of brown rice as an option or replacement for white rice in government institutions and food programs. This relatively simple dietary intervention has the potential to substantially diminish the burden of diabetes in Asia and elsewhere. PMID:26017321

  9. Study design and methods for a randomized crossover trial substituting brown rice for white rice on diabetes risk factors in India.

    PubMed

    Wedick, Nicole M; Sudha, Vasudevan; Spiegelman, Donna; Bai, Mookambika Ramya; Malik, Vasanti S; Venkatachalam, Siva Sankari; Parthasarathy, Vijayalaksmi; Vaidya, Ruchi; Nagarajan, Lakshmipriya; Arumugam, Kokila; Jones, Clara; Campos, Hannia; Krishnaswamy, Kamala; Willett, Walter; Hu, Frank B; Anjana, Ranjit Mohan; Mohan, Viswanathan

    2015-01-01

    India has the second largest number of people with diabetes in the world following China. Evidence indicates that consumption of whole grains can reduce the risk of type 2 diabetes. This article describes the study design and methods of a trial in progress evaluating the effects of substituting whole grain brown rice for polished (refined) white rice on biomarkers of diabetes risk (glucose metabolism, dyslipidemia, inflammation). This is a randomized controlled clinical trial with a crossover design conducted in Chennai, India among overweight but otherwise healthy volunteers aged 25-65 y with a body mass index ≥23 kg/m(2) and habitual rice consumption ≥200 g/day. The feasibility and cultural appropriateness of this type of intervention in the local environment will also be examined. If the intervention is efficacious, the findings can be incorporated into national-level policies which could include the provision of brown rice as an option or replacement for white rice in government institutions and food programs. This relatively simple dietary intervention has the potential to substantially diminish the burden of diabetes in Asia and elsewhere. PMID:26017321

  10. Genetic Predisposition to Weight Loss and Regain With Lifestyle Intervention: Analyses From the Diabetes Prevention Program and the Look AHEAD Randomized Controlled Trials.

    PubMed

    Papandonatos, George D; Pan, Qing; Pajewski, Nicholas M; Delahanty, Linda M; Peter, Inga; Erar, Bahar; Ahmad, Shafqat; Harden, Maegan; Chen, Ling; Fontanillas, Pierre; Wagenknecht, Lynne E; Kahn, Steven E; Wing, Rena R; Jablonski, Kathleen A; Huggins, Gordon S; Knowler, William C; Florez, Jose C; McCaffery, Jeanne M; Franks, Paul W

    2015-12-01

    Clinically relevant weight loss is achievable through lifestyle modification, but unintentional weight regain is common. We investigated whether recently discovered genetic variants affect weight loss and/or weight regain during behavioral intervention. Participants at high-risk of type 2 diabetes (Diabetes Prevention Program [DPP]; N = 917/907 intervention/comparison) or with type 2 diabetes (Look AHEAD [Action for Health in Diabetes]; N = 2,014/1,892 intervention/comparison) were from two parallel arm (lifestyle vs. comparison) randomized controlled trials. The associations of 91 established obesity-predisposing loci with weight loss across 4 years and with weight regain across years 2-4 after a minimum of 3% weight loss were tested. Each copy of the minor G allele of MTIF3 rs1885988 was consistently associated with greater weight loss following lifestyle intervention over 4 years across the DPP and Look AHEAD. No such effect was observed across comparison arms, leading to a nominally significant single nucleotide polymorphism×treatment interaction (P = 4.3 × 10(-3)). However, this effect was not significant at a study-wise significance level (Bonferroni threshold P < 5.8 × 10(-4)). Most obesity-predisposing gene variants were not associated with weight loss or regain within the DPP and Look AHEAD trials, directly or via interactions with lifestyle. PMID:26253612

  11. A Randomized Pilot Trial of a Moderate Carbohydrate Diet Compared to a Very Low Carbohydrate Diet in Overweight or Obese Individuals with Type 2 Diabetes Mellitus or Prediabetes

    PubMed Central

    Saslow, Laura R.; Kim, Sarah; Daubenmier, Jennifer J.; Moskowitz, Judith T.; Phinney, Stephen D.; Goldman, Veronica; Murphy, Elizabeth J.; Cox, Rachel M.; Moran, Patricia; Hecht, Fredrick M.

    2014-01-01

    We compared the effects of two diets on glycated hemoglobin (HbA1c) and other health-related outcomes in overweight or obese adults with type 2 diabetes or prediabetes (HbA1c>6%). We randomized participants to either a medium carbohydrate, low fat, calorie-restricted, carbohydrate counting diet (MCCR) consistent with guidelines from the American Diabetes Association (n = 18) or a very low carbohydrate, high fat, non calorie-restricted diet whose goal was to induce nutritional ketosis (LCK, n = 16). We excluded participants receiving insulin; 74% were taking oral diabetes medications. Groups met for 13 sessions over 3 months and were taught diet information and psychological skills to promote behavior change and maintenance. At 3 months, mean HbA1c level was unchanged from baseline in the MCCR diet group, while it decreased 0.6% in the LCK group; there was a significant between group difference in HbA1c change favoring the LCK group (−0.6%, 95% CI, −1.1% to −0.03%, p = 0.04). Forty-four percent of the LCK group discontinued one or more diabetes medications, compared to 11% of the MCCR group (p = 0.03); 31% discontinued sulfonylureas in the LCK group, compared to 5% in the MCCR group (p = 0.05). The LCK group lost 5.5 kg vs. 2.6 kg lost in MCCR group (p = 0.09). Our results suggest that a very low carbohydrate diet coupled with skills to promote behavior change may improve glycemic control in type 2 diabetes while allowing decreases in diabetes medications. This clinical trial was registered with ClinicalTrials.gov, number NCT01713764. PMID:24717684

  12. Can chronic disease management programs for patients with type 2 diabetes reduce productivity-related indirect costs of the disease? Evidence from a randomized controlled trial.

    PubMed

    Adepoju, Omolola E; Bolin, Jane N; Ohsfeldt, Robert L; Phillips, Charles D; Zhao, Hongwei; Ory, Marcia G; Forjuoh, Samuel N

    2014-04-01

    The objective was to assess the impacts of diabetes self-management programs on productivity-related indirect costs of the disease. Using an employer's perspective, this study estimated the productivity losses associated with: (1) employee absence on the job, (2) diabetes-related disability, (3) employee presence on the job, and (4) early mortality. Data were obtained from electronic medical records and survey responses of 376 adults aged ≥18 years who were enrolled in a randomized controlled trial of type 2 diabetes self-management programs. All study participants had uncontrolled diabetes and were randomized into one of 4 study arms: personal digital assistant (PDA), chronic disease self-management program (CDSMP), combined PDA and CDSMP, and usual care (UC). The human-capital approach was used to estimate lost productivity resulting from 1, 2, 3, and 4 above, which are summed to obtain total productivity loss. Using robust regression, total productivity loss was modeled as a function of the diabetes self-management programs and other identified demographic and clinical characteristics. Compared to subjects in the UC arm, there were no statistically significant differences in productivity losses among persons undergoing any of the 3 diabetes management interventions. Males were associated with higher productivity losses (+$708/year; P<0.001) and persons with greater than high school education were associated with additional productivity losses (+$758/year; P<0.001). Persons with more than 1 comorbid condition were marginally associated with lower productivity losses (-$326/year; P=0.055). No evidence was found that the chronic disease management programs examined in this trial affect indirect productivity losses. PMID:24152055

  13. Effects of Prior Intensive Insulin Therapy and Risk Factors on Visual Quality-of-Life in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Cohort

    PubMed Central

    Gubitosi-Klug, Rose A.; Sun, Wanjie; Cleary, Patricia A.; Braffett, Barbara H.; Aiello, Lloyd Paul; Das, Arup; Tamborlane, William; Klein, Ronald

    2016-01-01

    Importance Preservation of visual acuity in patients with diabetes is critical to preserve VQOL. Interventions to improve glycemic control through early intensive treatment of diabetes reduce rates of severe retinopathy and preserve VA. Objective To assess the effect of prior intensive treatment and risk factors on visual quality of life (VQOL) in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study (DCCT/EDIC) cohort. Design Randomized controlled clinical trial followed by an observational follow-up study. Setting 28 institutions across the United States and Canada. Participants 1184 DCCT/EDIC participants with type 1 diabetes completed the National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ) during EDIC years 17-20, up to thirty years after the start of the DCCT. Main Outcome Measures The 25-item NEI-VFQ was administered. Visual acuity (VA) was measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol and the presence and severity of retinopathy and macular edema were detected by masked grading of stereoscopic color fundus photographs using the ETDRS retinopathy severity scheme. The composite VQOL and subscales were scored on a scale of 0 to 100 corresponding to poor to excellent function, respectively. Quantile regression was used to assess the treatment/risk factor effect on median QOL score, owing to the ordinal scoring and a skewed distribution. Results The overall average VQOL for DCCT/EDIC participants with a 30 year duration of diabetes was high (median 91.7, interquartile (IQR), 89.7-96.9). After adjustment for gender, age, HbA1c, and retinopathy level at DCCT baseline, the former intensive (INT) treatment group had a significant, albeit modest, improvement in overall VQOL compared to the former conventional (CONV) diabetes treatment group (median difference −1.0 [−1.7, −0.3], p=0.0058). This beneficial treatment effect was fully attributed to the prior

  14. Diabetic cardiomyopathy

    PubMed Central

    Asghar, Omar; Al-Sunni, Ahmed; Khavandi, Kaivan; Khavandi, Ali; Withers, Sarah; Greenstein, Adam; Heagerty, Anthony M.; Malik, Rayaz A.

    2009-01-01

    Diabetic cardiomyopathy is a distinct primary disease process, independent of coronary artery disease, which leads to heart failure in diabetic patients. Epidemiological and clinical trial data have confirmed the greater incidence and prevalence of heart failure in diabetes. Novel echocardiographic and MR (magnetic resonance) techniques have enabled a more accurate means of phenotyping diabetic cardiomyopathy. Experimental models of diabetes have provided a range of novel molecular targets for this condition, but none have been substantiated in humans. Similarly, although ultrastructural pathology of the microvessels and cardiomyocytes is well described in animal models, studies in humans are small and limited to light microscopy. With regard to treatment, recent data with thiazoledinediones has generated much controversy in terms of the cardiac safety of both these and other drugs currently in use and under development. Clinical trials are urgently required to establish the efficacy of currently available agents for heart failure, as well as novel therapies in patients specifically with diabetic cardiomyopathy. PMID:19364331

  15. Effect of orlistat on glycaemic control in overweight and obese patients with type 2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials.

    PubMed

    Aldekhail, N M; Logue, J; McLoone, P; Morrison, D S

    2015-12-01

    Orlistat is an effective adjunctive treatment to lifestyle modifications in the treatment of obesity. While the majority of current evidence is on the effect of orlistat in obese patients without diabetes, some studies suggest that patients who are obese and have diabetes mellitus lose more weight and have greater improvements in diabetic outcomes when treated with orlistat plus a lifestyle intervention than when treated by lifestyle interventions alone. The aim of this study was to review the evidence of the effects of orlistat on glycaemic control in overweight and obese patients with type 2 diabetes. A systematic review of randomized controlled trials of orlistat in people with type 2 diabetes reporting diabetes outcomes in studies published between January 1990 and September 2013 was conducted. We searched for articles published in English in MEDLINE and EMBASE. Inclusion criteria included all randomized controlled trials of orlistat carried out on adult participants with a body mass index of 25 kg m(-2) or over diagnosed with type 2 diabetes, which reported weight change and at least one diabetic outcome. A total of 765 articles were identified out of which 12 fulfilled the inclusion criteria. The overall mean weight reduction (3, 6 and 12 months) in the orlistat group was -4.25 kg (95% CI: -4.5 to -3.9 kg). The mean weight difference between treatment and control groups was -2.10 kg (95% CI: -2.3 to -1.8 kg, P < 0.001), the mean HbA1c difference was -6.12 mmol mol(-1) (95% CI: -10.3 to -1.9 mmol mol(-1) , P < 0.004) and the mean fasting blood glucose difference was -1.16 mmol L(-1) (95% CI: -1.4 to -0.8 mmol L(-1) , P < 0.001). Treatment with orlistat plus lifestyle intervention resulted in significantly greater weight loss and improved glycaemic control in overweight and obese patients with type 2 diabetes compared with lifestyle intervention alone. PMID:26345590

  16. Development, Validation, and Evaluation of Web-Based Iranian Diabetic Personal Health Record: Rationale for and Protocol of a Randomized Controlled Trial

    PubMed Central

    Mazloum-Khorasani, Zahra

    2016-01-01

    Background Diabetes is one of the four main types of noncommunicable or chronic diseases. Iran is among the countries with the highest incidence of diabetic patients. A study demonstrated that the collection of diabetic data is neither organized nor standardized. There is currently no instance of electronic personal health records particularly used for diabetic patients in Iran, hence the need for one, which will be useful for self-care of diabetic patients. Objective The objective of the study is to examine the impact of a Web-based diabetic personal health record (DPHR) on the self-care status of diabetic patients as compared with the control group. Methods This study is a randomized control trial, which involves a systematic review of literature of the preferred data elements regarding a DPHR, and reevaluating the results with the opinions of local endocrinologists. Inclusion criteria were as follows: type 2 diabetic patients between 20-70 of age who live in the Mashhad City and having the disease for at least one year. The sample size is 72 people that were randomly assigned to the control and intervention groups. The participants in the intervention group were allowed access to the Web-based DPHR system, while those in the control group will continue to receive the usual care for 4 months. The study primary outcome measures include self-care status of participants and planned visit adherence. Results At the moment, there is an ongoing recruitment of participants, and preliminary results will be published in early 2016. Conclusions We expect the final DPHR model, developed and tested during this study, to help diabetic patients to actively participate in their care management process, and also to empower the physician in providing more quality informed decisions regarding their patients. Trial Registration irct.ir IRCT2013082914522N1; http://www.irct.ir/searchresult.php?id=14522&number=1 (Archived by WebCite at http://www.webcitation.org/6cC4PCcau). PMID

  17. Randomized trial showing efficacy and safety of twice-daily remogliflozin etabonate for the treatment of type 2 diabetes.

    PubMed

    Sykes, A P; O'Connor-Semmes, R; Dobbins, R; Dorey, D J; Lorimer, J D; Walker, S; Wilkison, W O; Kler, L

    2015-01-01

    We compared the efficacy of twice-daily doses of remogliflozin etabonate (RE) and once-daily pioglitazone with placebo for reduction in glycated haemoglobin (HbA1c) concentration. In this 12-week, double-blind, randomized, active- and placebo-controlled trial, 336 treatment-naïve subjects with type 2 diabetes and an HbA1c of 7.0-9.5% (53-80 mmol/mol) were randomized to RE (50, 100, 250, 500 or 1000 mg twice daily), matching placebo or 30 mg pioglitazone once daily. The primary endpoint was change in HbA1c from baseline. Other endpoints included changes in body weight, lipid levels, safety and tolerability. RE produced a decreasing dose response in HbA1c at week 12 (p < 0.001), with reductions in HbA1c versus placebo ranging from 0.64 to 1.07% (p < 0.001). Statistically significant reductions in body weight for RE compared with placebo were also observed. Twice-daily RE resulted in a dose-ordered improvement in glycaemic control and was generally well tolerated. PMID:25223369

  18. Factors Associated with Recruitment and Retention in Randomized Controlled Trials of Behavioral Interventions for Patients with Pediatric Type 1 Diabetes.

    PubMed

    Herbert, Linda J; Gillespie, Catherine; Monaghan, Maureen; Holmes, Clarissa; Streisand, Randi

    2016-06-01

    The purpose of this study is to describe recruitment and retention experiences from three behavioral randomized controlled trials conducted among youth with type 1 diabetes. Eligibility, recruitment, and retention data were examined. Study-specific differential study participation and loss-to-follow-up analyses assessed the relations of patient characteristics with treatment completion and 6-month retention. Multivariable logistic regression identified factors independently associated with 6-month retention among all participants. Approximately 70-92 % of randomized participants completed treatment and 58-90 % were retained for follow-up. Older patients and non-Caucasian patients were less likely to enroll. Treatment completion and 6-month retention were less likely among youth who were older, had worse baseline glycemic control, lower household income, and/or unmarried parents. Some subgroups of patients are less likely to participate in research and are more susceptible to loss-to-follow-up. More work is needed to understand the facilitators and barriers to research participation. PMID:26661924

  19. Effect of probiotics on metabolic profiles in type 2 diabetes mellitus: A meta-analysis of randomized, controlled trials.

    PubMed

    Li, Caifeng; Li, Xin; Han, Hongqiu; Cui, Hailong; Peng, Min; Wang, Guolin; Wang, Zhiqiang

    2016-06-01

    Type 2 diabetes mellitus (T2DM) is a prevalent metabolic disease which is imposing heavy burden on global health and economy. Recent studies indicate gut microbiota play important role on the pathogenesis and metabolic disturbance of T2DM. As an effective mean of regulating gut microbiota, probiotics are live micro-organisms that are believed to provide a specific health benefit on the host. Whether probiotic supplementation could improve metabolic profiles by modifying gut microbiota in T2DM or not is still in controversy.The aim of the study is to assess the effect of probiotic supplementation on metabolic profiles in T2DM.We searched PubMed, EMBASE, and Cochrane Library up to 12 April 2016. Two review authors independently assessed study eligibility, extracted data, and evaluated risk of bias of included studies. Data were pooled by using the random-effect model and expressed as standardized mean difference (SMD) with 95% confidence interval (CI). Heterogeneity was assessed and quantified (I).A total of 12 randomized controlled trials (RCTs) were included. Lipid profiles (n = 508) and fasting blood glucose (FBG) (n = 520) were reported in 9 trials; the homeostasis model of assessment for insulin resistance index (HOMA-IR) (n = 368) and glycosylated hemoglobin (HbA1c) (n = 380) were reported in 6 trials. Probiotics could alleviate FBG (SMD -0.61 mmol/L, 95% CI [-0.92, -0.30], P = 0.0001). Probiotics could increase high-density lipoprotein-cholesterol (HDL-C) (SMD 0.42 mmol/L, 95% CI [0.08, 0.76], P = 0.01). There were no significant differences in low-density lipoprotein-cholesterol (LDL-C), total cholesterol (TC), triglyceride (TG), HbA1c and HOMA-IR between the treatment group and the control group.Probiotics may improve glycemic control and lipid metabolism in T2DM. Application of probiotic agents might become a new method for glucose management in T2DM. PMID:27368052

  20. The Effect of Sitagliptin on Carotid Artery Atherosclerosis in Type 2 Diabetes: The PROLOGUE Randomized Controlled Trial

    PubMed Central

    Oyama, Jun-ichi; Murohara, Toyoaki; Kitakaze, Masafumi; Ishizu, Tomoko; Sato, Yasunori; Kitagawa, Kazuo; Kamiya, Haruo; Ajioka, Masayoshi; Ishihara, Masaharu; Dai, Kazuoki; Sata, Masataka; Maemura, Koji; Tomiyama, Hirofumi; Higashi, Yukihito; Kaku, Kohei; Matsuhisa, Munehide; Yamashita, Kentaro; Bando, Yasuko K.; Kashihara, Naoki; Ueda, Shinichiro; Inoue, Teruo; Tanaka, Atsushi; Node, Koichi

    2016-01-01

    Background Experimental studies have suggested that dipeptidyl peptidase-4 (DPP-4) inhibitors provide cardiovascular protective effects. We performed a randomized study to evaluate the effects of sitagliptin added on to the conventional therapy compared with conventional therapy alone (diet, exercise, and/or drugs, except for incretin-related agents) on the intima-media thickness (IMT) of the carotid artery, a surrogate marker for the evaluation of atherosclerotic cardiovascular disease, in people with type 2 diabetes mellitus (T2DM). Methods and Findings We used a multicenter PROBE (prospective, randomized, open label, blinded endpoint) design. Individuals aged ≥30 y with T2DM (6.2% ≤ HbA1c < 9.4%) were randomly allocated to receive either sitagliptin (25 to 100 mg/d) or conventional therapy. Carotid ultrasound was performed at participating medical centers, and all parameters were measured in a core laboratory. Of the 463 enrolled participants with T2DM, 442 were included in the primary analysis (sitagliptin group, 222; conventional therapy group, 220). Estimated mean (± standard error) common carotid artery IMT at 24 mo of follow-up in the sitagliptin and conventional therapy groups was 0.827 ± 0.007 mm and 0.837 ± 0.007 mm, respectively, with a mean difference of −0.009 mm (97.2% CI −0.028 to 0.011, p = 0.309). HbA1c level at 24 mo was significantly lower with sitagliptin than with conventional therapy (6.56% ± 0.05% versus 6.72% ± 0.05%, p = 0.008; group mean difference −0.159, 95% CI −0.278 to −0.041). Episodes of serious hypoglycemia were recorded only in the conventional therapy group, and the rate of other adverse events was not different between the two groups. As it was not a placebo-controlled trial and carotid IMT was measured as a surrogate marker of atherosclerosis, there were some limitations of interpretation. Conclusions In the PROLOGUE study, there was no evidence that treatment with sitagliptin had an additional effect on the

  1. A Randomized Controlled Trial of Conbercept Pretreatment before Vitrectomy in Proliferative Diabetic Retinopathy

    PubMed Central

    Yang, Xiaochun; Wang, Ruili; Mei, Yan; Liu, Jun; Zhang, Ting; Zhao, Haiyan

    2016-01-01

    Purpose. To determine the efficacy and safety of preoperative intravitreal conbercept (IVC) injection before vitrectomy for proliferative diabetic retinopathy (PDR). Methods. 107 eyes of 88 patients that underwent pars plana vitrectomy (PPV) for active PDR were enrolled. All patients were assigned randomly to either preoperative IVC group or control group. Follow-up examinations were performed for three months after surgery. The primary bioactivity measures were severity of intraoperative bleeding, incidence of early and late recurrent VH, vitreous clear-up time, and best-corrected visual acuity (BCVA) levels. The secondary safety measures included intraocular pressure, endophthalmitis, rubeosis, tractional retinal detachment, and systemic adverse events. Results. The incidence and severity of intraoperative bleeding were significantly lower in IVC group than in the control group. The average vitreous clear-up time of early recurrent VH was significantly shorter in IVC group compared with that in control group. There was no significant difference in vitreous clear-up time of late recurrent VH between the two groups. Patients that received pretreatment of conbercept had much better BCVA at 3 days, 1 week, and 1 month after surgery than control group. Moreover, both patients with improved BCVA were greater in IVC group than in control group at each follow-up. Conclusions. Conbercept pretreatment could be an effective adjunct to vitrectomy in accelerating postoperative vitreous clear-up and acquiring stable visual acuity restoration for PDR. PMID:27034822

  2. Explaining the effects of an intervention designed to promote evidence-based diabetes care: a theory-based process evaluation of a pragmatic cluster randomised controlled trial

    PubMed Central

    Francis, Jillian J; Eccles, Martin P; Johnston, Marie; Whitty, Paula; Grimshaw, Jeremy M; Kaner, Eileen FS; Smith, Liz; Walker, Anne

    2008-01-01

    Background The results of randomised controlled trials can be usefully illuminated by studies of the processes by which they achieve their effects. The Theory of Planned Behaviour (TPB) offers a framework for conducting such studies. This study used TPB to explore the observed effects in a pragmatic cluster randomised controlled trial of a structured recall and prompting intervention to increase evidence-based diabetes care that was conducted in three Primary Care Trusts in England. Methods All general practitioners and nurses in practices involved in the trial were sent a postal questionnaire at the end of the intervention period, based on the TPB (predictor variables: attitude; subjective norm; perceived behavioural control, or PBC). It focussed on three clinical behaviours recommended in diabetes care: measuring blood pressure; inspecting feet; and prescribing statins. Multivariate analyses of variance and multiple regression analyses were used to explore changes in cognitions and thereby better understand trial effects. Results Fifty-nine general medical practitioners and 53 practice nurses (intervention: n = 55, 41.98% of trial participants; control: n = 57, 38.26% of trial participants) completed the questionnaire. There were no differences between groups in mean scores for attitudes, subjective norms, PBC or intentions. Control group clinicians had 'normatively-driven' intentions (i.e., related to subjective norm scores), whereas intervention group clinicians had 'attitudinally-driven' intentions (i.e., related to attitude scores) for foot inspection and statin prescription. After controlling for effects of the three predictor variables, this group difference was significant for foot inspection behaviour (trial group × attitude interaction, beta = 0.72, p < 0.05; trial group × subjective norm interaction, beta = -0.65, p < 0.05). Conclusion Attitudinally-driven intentions are proposed to be more consistently translated into action than normatively

  3. Comparison of clinical effectiveness of laser acupuncture and amitriptyline in diabetic peripheral neuropathy (DPN): a sham controlled randomized clinical trial

    NASA Astrophysics Data System (ADS)

    Hassan Khan, Imran; Anwar, Shahzad; Hanif, Asif; Ayub, Muhammad; Jamil Raja, Arsalan

    2014-02-01

    Background: Painful neuropathy is a very common complication in diabetic patients. Various treatment strategies like manual therapies, conservative management, drug therapy and exercise have been opted for this problem. Studies have shown clinical effectiveness of laser acupuncture as well. On the other hand, Amitryptaline is also a commonly used treatment for this disease. We aim to compare the efficacy of both treatments. Objective: To assess the effect of laser acupuncture in patients suffering from painful diabetic neuropathy and its comparison with standard of care. Patients and Method: This study was conducted in Diabetic and Endocrine Management Center (DEMC) Lahore General Hospital, Lahore, Pakistan. A randomized control trial (RCT) was opted and a total of 164 patients were chosen using Non-probability purposive sampling technique. Pain was graded by using a patient friendly Visual Analogue Score (VAS), scoring from 0 to 10. Treatment was done involving organized fortnightly follow ups. Data of all patients was recorded on Performa and was entered and analyzed for descriptive statistics in PASW 18 (IBM®. SPSS). Results: A total of 164 subjects were included in the study who were subdivided into three groups labeled as A, B and C for laser therapy treatment, amitryptaline treatment and controls respectively. The mean age of subjects was 51.54+/-10.46 in Group A, 49.38+/-10.56 in Group B and 51.70+/-11.43 in Group C. The difference of mean ages in all study groups was statistically insignificant (p-value= 0.469). The average pain score in patients who received laser therapy was 5.95+/-0.91 before treatment, whereas after treatment it was 4.31+/-0.98. The mean pain score in subjects having Amitryptaline before starting the treatment was 6.87+/-0.71 and after treatment, it was 6.23+/-0.98. The mean score for daily life activities in subjects who received laser therapy was 9.562.37 before treatment, while after treatment it was 7.56+/-1.54. The average score

  4. Report from the 1st Cardiovascular Outcome Trial (CVOT) Summit of the Diabetes & Cardiovascular Disease (D&CVD) EASD Study Group.

    PubMed

    Schnell, Oliver; Standl, Eberhard; Catrinoiu, Doina; Genovese, Stefano; Lalic, Nebojsa; Skra, Jan; Valensi, Paul; Ceriello, Antonio

    2016-01-01

    The 1st Cardiovascular Outcome Trial (CVOT) Summit of the Diabetes & Cardiovascular Disease (D&CVD) EASD Study Group was held during the annual meeting on 30 October 2015 in Munich. This summit was organized in light of recently published and numerous ongoing CVOTs on diabetes, which have emerged in response to the FDA and the EMA Guidelines. The CVOT Summit stands as a novel conference setup, with the aim of serving as a reference meeting for all topics related to CVOTs in diabetes. Members of the steering committee of the D&CVD EASD Study Group constitute the backbone of the summit. It included presentations of key results on DPP-4 inhibitors, GLP-1-Analogues, SGLT-2 inhibitors, acarbose and insulins. Diabetologists' and cardiologists' perspective on the potential need of new study designs were also highlighted. Furthermore, panel discussions on the design of CVOTs on diabetes were included in the program. The D&CVD EASD Study Group will continue its activity. In-depth discussions and presentations of new CVOTs like LEADER, will be resumed at the 2nd CVOT on diabetes of the D&CVD EASD Study Group, which will be held from 20-22 October 2016 in Munich ( http://www.dcvd.org). PMID:26892706

  5. The impact of Multimedia Software Support on the Knowledge and Self-Care Behaviors of Patients with Type 2 Diabetes: a Randomized Clinical Trial

    PubMed Central

    Farmahini Farahani, Moloud; Purfarzad, Zahra; Ghorbani, Mojtaba; Ghamari Zare, Zohre; Ghorbani, Fateme

    2016-01-01

    Introduction: Education is the most effective and economical part of diabetes treatment. The purpose of this study was to investigate the effect of a training program with multimedia software on the knowledge and self-care behaviors of patients with type 2 diabetes. Methods: This study was a randomized controlled clinical trial in which 60 patients referred to diabetes clinic at Arak city were divided randomly into experimental (n=30) and control (n=30) groups. The instruments for collecting data were "Summary of Diabetes self-care activities questionnaire" and "knowledge of self-care in patients with diabetes". Data were collected before and 2 months after the intervention in the both groups. Educational program with equal content was applied for both experimental group (self-care program with multimedia software support) & control group (lecture and presentation with PowerPoint). Data analysis was done using SPSS Ver.13. Results: Implementation of the self-care program with multimedia software support resulted in improvements in patients’ self-care behaviors in the experimental group, whereas these behaviors had not significant changes in the control group after eight weeks. There was a significant difference in the mean score of knowledge in both the experiment and control groups before and after the intervention. Conclusion: Considering beneficial effects of training program with multimedia software support on the knowledge and self-care behaviors and the importance of this issue, suggested that the patients preferably provide terms of use of educational software for themselves. PMID:27354975

  6. Randomized controlled clinical trial of a combination therapy of vildagliptin plus an α-glucosidase inhibitor for patients with type II diabetes mellitus

    PubMed Central

    SU, YONG; SU, YA-LI; LV, LI-FANG; WANG, LI-MIN; LI, QUAN-ZHONG; ZHAO, ZHI-GANG

    2014-01-01

    The aim of this study was to assess the efficacy of a combination therapy of vildagliptin plus an α-glucosidase inhibitor for patients with type II diabetes mellitus. Type II diabetic patients exhibiting poor glycemic control following α-glucosidase inhibitor treatment for at least two months were selected and randomly distributed into vildagliptin and placebo groups. The body weight, fasting blood glucose (FBG), postprandial glucose (PPG), glycated hemoglobin (HBA1c) and blood lipid levels and hepatorenal functions of the patients were determined before and 12 weeks after the trial. Following the trial, the FBG, PPG, HbA1c, cholesterol (CHOL) and triglyceride (TG) levels in the vildagliptin group were significantly decreased compared with the pretreatment levels (P<0.05), whereas only the PPG level in the placebo group decreased (P<0.05). The FBG, PPG and HbA1c levels in the vildagliptin group were markedly lower than those in the placebo group 12 weeks after the trial. A comparison of the body weights and hepatorenal functions before and after the trial or between groups did not show statistically significant differences. The combination therapy of vildagliptin plus an α-glucosidase inhibitor effectively reduced the FBG, PPG and HbA1c levels in patients without inducing weight gain or hepatorenal dysfunction. However, the therapy may have caused a reduction in the blood lipid levels. PMID:24926379

  7. Effectiveness of a Training Course for General Practice Nurses in Motivation Support in Type 2 Diabetes Care: A Cluster-Randomised Trial

    PubMed Central

    Juul, Lise; Maindal, Helle T.; Zoffmann, Vibeke; Frydenberg, Morten; Sandbaek, Annelli

    2014-01-01

    Background Type 2 diabetes is a common metabolic disease with the potential for prevention of complications. The prevention requires a high level of lasting actions from the patients, which may be burdensome. The aim of this trial was to evaluate the effectiveness of a training course for general practice nurses in motivation support at 18 months follow-up in the affiliated type 2 diabetes population. Methods Forty general practices with nurse-led diabetes consultations from the area of Aarhus, Denmark were randomised 1∶1 to either intervention or usual practice. Intervention practices were offered a 16-hour Self-determination theory - based course including communication training for general practice nurses delivered over 10 months. The affiliated diabetes populations (aged 40–74 years) were identified from registers (intervention n = 2,005; usual n = 2,029). Primary outcomes were register-based glycated haemoglobin (HbA1c) -, total cholesterol levels, and well-being measured by the Problem Areas In Diabetes scale (PAID) and the mental component summary score, SF12 (SF12, mcs). Intention-to-treat analyses were performed. Predefined subgroups analyses were performed. Results The differences between the intervention- and the control practices’ mean HbA1c and total cholesterol at follow-up adjusted for baseline values and clustering were respectively: −0.02%-points (95% CI: −0.11 to 0.07; p: 0.67); 0.08 mmol/l (95% CI: 0.01 to 0.15; p: 0.02). Differences in median scores adjusted for clustering were for PAID: 1.25; p = 0.31 and SF12, mcs: 0.99; p = 0.15. Women in intervention practices differed from women in usual practices on mean HbA1c: −0.12%-points (−0.23 to −0.02; p = 0.02) and SF12, mcs: 2.6; p = 0.01. Conclusions Offering a training course for general practice nurses in applying the Self-determination theory in current type 2 diabetes care had no effect compared with usual practice measured by HbA1c and total cholesterol

  8. Randomized Clinical Trial Evaluating Intravitreal Ranibizumab or Saline for Vitreous Hemorrhage from Proliferative Diabetic Retinopathy

    PubMed Central

    Bhavsar, Abdhish R.; Torres, Karisse; Beck, Roy W.; Bressler, Neil M.; Ferris, Frederick L.; Friedman, Scott M.; Glassman, Adam R.; Maturi, Raj K.; Melia, Michele; Singer, Michael A.; Stockdale, Cynthia R.

    2014-01-01

    Objective To evaluate intravitreal ranibizumab compared with intravitreal saline injections on vitrectomy rates for vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR). Main Outcome Cumulative probability of vitrectomy within 16 weeks. Methods Study eyes had VH from PDR precluding panretinal photocoagulation (PRP) completion. Eyes were randomly assigned to 0.5-mg ranibizumab (N = 125) or saline (N = 136) at baseline, 4, and 8 weeks. Results Cumulative probability of vitrectomy by 16 weeks was 12% with ranibizumab versus 17% with saline (difference 4%, 95% confidence interval −4%–13%) and of complete PRP without vitrectomy by 16-weeks was 44% and 31% respectively (P = 0.05). The mean (±SD) visual acuity improvement from baseline to 12 weeks was 22±23 letters and 16±31 letters respectively (P = 0.04). Recurrent VH occurred within 16 weeks in 6% and 17% respectively (P = 0.01). One eye developed endophthalmitis after saline. Conclusions Overall the 16 week vitrectomy rates were lower than expected in both groups. This study suggests little likelihood of a clinically important difference between ranibizumab and saline on the rate of vitrectomy by 16 weeks in eyes with VH from PDR. Short term secondary outcomes including visual acuity improvement, increased PRP completion rates, and reduced recurrent VH rates suggest biologic activity of ranibizumab. Long term benefits remain unknown. Whether vitrectomy rates after saline or ranibizumab are different than observation alone cannot be determined from this study. Application to Clinical Practice Intravitreal ranibizumab does not appear to reduce vitrectomy rates compared with saline for VH from PDR. PMID:23370902

  9. A Randomized Clinical Trial Study: Anti-Oxidant, Anti-hyperglycemic and Anti-Hyperlipidemic Effects of Olibanum Gum in Type 2 Diabetic Patients.

    PubMed

    Azadmehr, Abbas; Ziaee, Amir; Ghanei, Laleh; Fallah Huseini, Hassan; Hajiaghaee, Reza; Tavakoli-Far, Bahareh; Kordafshari, Gholamreza

    2014-01-01

    Diabetes is a common metabolic disease in the world that has many adverse effects. Olibanum gum resin (from trees of the genus Boswellia) has traditionally been used in the treatment of various diseases such as diabetes. The aim of this study was the comparison of Olibanum gum resin effect with placebo on the treatment of type 2 diabetes. Inclusion criteria was diabetic patients with fasting blood sugar (FBS) =140-200 mg/dL. This study has been designed as double-blined clinical trial on 71 patients with type 2 diabetes and the patients randomly were divided to interventional and placebo groups. The patients on standard anti-diabetic therapy (metformin) treated with Olibanum gum resin (400 mg caps) and placebo tow times per day for 12 weeks, respectively. At the end of the twelfth week, the FBS, HbA1c, Insulin, total Cholesterol (Chol), LDL, Triglyceride (TG), HDL and other parameters were measured. The Olibanum gum resin lowered the FBS, HbA1c, Insulin, Chol, LDL and TG levels significantly (p < 0.001, p < 0.001, p <0.001, p = 0.003, p < 0.001 and p < 0.001, respectively) without any significant effects on the other blood lipid levels and liver/kidney function tests (p > 0.05) compared with the placebo at the endpoint. Moreover, this plant showed anti-oxidant effect and also no adverse effects were reported. The results suggest that Olibanum gum resin could be used as a safe anti-oxidant, anti-hyperglycemic and anti-hyperlipidemic agent for type 2 diabetic patients. PMID:25276202

  10. A Randomized Clinical Trial Study: Anti-Oxidant, Anti-hyperglycemic and Anti-Hyperlipidemic Effects of Olibanum Gum in Type 2 Diabetic Patients

    PubMed Central

    Azadmehr, Abbas; Ziaee, Amir; Ghanei, Laleh; Fallah Huseini, Hassan; Hajiaghaee, Reza; Tavakoli-far, Bahareh; Kordafshari, Gholamreza

    2014-01-01

    Diabetes is a common metabolic disease in the world that has many adverse effects. Olibanum gum resin (from trees of the genus Boswellia) has traditionally been used in the treatment of various diseases such as diabetes. The aim of this study was the comparison of Olibanum gum resin effect with placebo on the treatment of type 2 diabetes. Inclusion criteria was diabetic patients with fasting blood sugar (FBS) =140-200 mg/dL. This study has been designed as double-blined clinical trial on 71 patients with type 2 diabetes and the patients randomly were divided to interventional and placebo groups. The patients on standard anti-diabetic therapy (metformin) treated with Olibanum gum resin (400 mg caps) and placebo tow times per day for 12 weeks, respectively. At the end of the twelfth week, the FBS, HbA1c, Insulin, total Cholesterol (Chol), LDL, Triglyceride (TG), HDL and other parameters were measured. The Olibanum gum resin lowered the FBS, HbA1c, Insulin, Chol, LDL and TG levels significantly (p < 0.001, p < 0.001, p <0.001, p = 0.003, p < 0.001 and p < 0.001, respectively) without any significant effects on the other blood lipid levels and liver/kidney function tests (p > 0.05) compared with the placebo at the endpoint. Moreover, this plant showed anti-oxidant effect and also no adverse effects were reported. The results suggest that Olibanum gum resin could be used as a safe anti-oxidant, anti-hyperglycemic and anti-hyperlipidemic agent for type 2 diabetic patients. PMID:25276202

  11. Assessment of the Reporting Quality of Placebo-controlled Randomized Trials on the Treatment of Type 2 Diabetes With Traditional Chinese Medicine in Mainland China

    PubMed Central

    Zhao, Xiyan; Zhen, Zhong; Guo, Jing; Zhao, Tianyu; Ye, Ru; Guo, Yu; Chen, Hongdong; Lian, Fengmei; Tong, Xiaolin

    2016-01-01

    Abstract Placebo-controlled randomized trials are often used to evaluate the absolute effect of new treatments and are considered gold standard for clinical trials. No studies, however, have yet been conducted evaluating the reporting quality of placebo-controlled randomized trials. The current study aims to assess the reporting quality of placebo-controlled randomized trials on treatment of diabetes with Traditional Chinese Medicine (TCM) in Mainland China and to provide recommendations for improvements. China National Knowledge Infrastructure database, Wanfang database, China Biology Medicine database, and VIP database were searched for placebo-controlled randomized trials on treatment of diabetes with TCM. Review, animal experiment, and randomized controlled trials without placebo control were excluded. According to Consolidated Standards of Reporting Trials (CONSORT) 2010 checklists items, each item was given a yes or no depending on whether it was reported or not. A total of 68 articles were included. The reporting percentage in each article ranged from 24.3% to 73%, and 30.9% articles reported more than 50% of the items. Seven of the 37 items were reported more than 90% of the items, whereas 7 items were not mentioned at all. The average reporting for “title and abstract,” “introduction,” “methods,” “results,” “discussion,” and “other information” was 43.4%, 78.7%, 40.1%, 49.9%, 71.1%, and 17.2%, respectively. The percentage of each section had increased after 2010. In addition, the reporting of multiple study centers, funding, placebo species, informed consent forms, and ethical approvals were 14.7%, 50%, 36.85%, 33.8%, and 4.4%, respectively. Although a scoring system was created according to the CONSORT 2010 checklist, it was not designed as an assessment tool. According to CONSORT 2010, the reporting quality of placebo-controlled randomized trials on the treatment of diabetes with TCM improved after 2010. Future improvements

  12. Design and baseline characteristics of the PODOSA (Prevention of Diabetes & Obesity in South Asians) trial: a cluster, randomised lifestyle intervention in Indian and Pakistani adults with impaired glycaemia at high risk of developing type 2 diabetes

    PubMed Central

    Douglas, Anne; Bhopal, Raj S; Bhopal, Ruby; Forbes, John F; Gill, Jason M R; McKnight, John; Murray, Gordon; Sattar, Naveed; Sharma, Anu; Wallia, Sunita; Wild, Sarah; Sheikh, Aziz

    2013-01-01

    Objectives To describe the design and baseline population characteristics of an adapted lifestyle intervention trial aimed at reducing weight and increasing physical activity in people of Indian and Pakistani origin at high risk of developing type 2 diabetes. Design Cluster, randomised controlled trial. Setting Community-based in Edinburgh and Glasgow, Scotland, UK. Participants 156 families, comprising 171 people with impaired glycaemia, and waist sizes ≥90 cm (men) and ≥80 cm (women), plus 124 family volunteers. Interventions Families were randomised into either an intensive intervention of 15 dietitian visits providing lifestyle advice, or a light (control) intervention of four visits, over a period of 3 years. Outcome measures The primary outcome is a change in mean weight between baseline and 3 years. Secondary outcomes are changes in waist, hip, body mass index, plasma blood glucose and physical activity. The cost of the intervention will be measured. Qualitative work will seek to understand factors that motivated participation and retention in the trial and families’ experience of adhering to the interventions. Results Between July 2007 and October 2009, 171 people with impaired glycaemia, along with 124 family volunteers, were randomised. In total, 95% (171/196) of eligible participants agreed to proceed to the 3-year trial. Only 13 of the 156 families contained more than one recruit with impaired glycaemia. We have recruited sufficient participants to undertake an adequately powered trial to detect a mean difference in weight of 2.5 kg between the intensive and light intervention groups at the 5% significance level. Over half the families include family volunteers. The main participants have a mean age of 52 years and 64% are women. Conclusions Prevention of Diabetes & Obesity in South Asians (PODOSA) is one of the first community-based, randomised lifestyle intervention trials in a UK South Asian population. The main trial results will

  13. Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus

    PubMed Central

    2013-01-01

    Background Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. Methods/Design This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50–200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary

  14. Design of a Randomized Controlled Trial of a Web-Based Intervention to Reduce Cardiovascular Disease Risk Factors among Remote Reservation-Dwelling American Indian Adults with Type 2 Diabetes

    ERIC Educational Resources Information Center

    Henderson, Jeffrey A.; Chubak, Jessica; O'Connell, Joan; Ramos, Maria C.; Jensen, Julie; Jobe, Jared B.

    2012-01-01

    We describe a randomized controlled trial, the Lakota Oyate Wicozani Pi Kte (LOWPK) trial, which was designed to determine whether a Web-based diabetes and nutritional intervention can improve risk factors related to cardiovascular disease (CVD) among a group of remote reservation-dwelling adult American Indian men and women with type 2 diabetes…

  15. The effects of vitamin D and calcium supplementation on pancreatic beta cell function, insulin sensitivity and glycemia in adults at high risk for diabetes. The CaDDM Randomized Controlled Trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Suboptimal vitamin D and calcium status has been associated with higher risk of type 2 diabetes in observational studies but evidence from trials is lacking. The objective of this trial was to determine whether vitamin D supplementation, with or without calcium, improves glucose homeostasis in adult...

  16. The key role of Shenyan Kangfu tablets, a Chinese patent medicine for diabetic nephropathy: study protocol for a randomized, double-blind and placebo-controlled clinical trial

    PubMed Central

    2013-01-01

    Background Diabetic nephropathy (DN) is a major microvascular complication with diabetes. In China, an estimated 34.7 percent of people diagnosed with diabetes have renal complications and a further 50 percent die of renal failure. Hence, identification of alternative treatments for these patients should be given priority. The Shenyan Kangfu tablet (SYKFT) is a new formulation of an existing and widely acclaimed Chinese herbal tea for treating qi-yin deficiency syndrome. Because a considerable portion of DN patients presenting with symptoms of swelling, fatigue and weak limbs would be diagnosed with qi-yin deficiency syndrome according to the traditional Chinese medicine (TCM) diagnostic criteria, we hypothesize that SYKFT may represent a complementary drug for DN patients with the corresponding syndrome. In view of this, we have designed a trial to assess the efficacy and safety of SYKFT for patients with diabetic nephropathy exhibiting signs of qi and yin deficiency. Methods This is a multicenter, double-blind, randomized controlled trial (RCT). The total target sample size is planned at 80 participants, with a balanced (1:1) treatment allocation. The experimental intervention will be SYKFY plus irbesartan (SI regimen) and the control intervention will be a placebo plus irbesartan (PI regimen). Participants will receive two courses of medication treatment each lasting 8 weeks. The primary outcome will be the composite of the quantitative 24-hour urinary protein level and urinary albumin excretion rate (UAER). Changes in urine albumin-to-creatinine ratio (UACR) and DN staging, and TCM symptom improvement will be the secondary outcome measures. Adverse events (AEs) will be monitored throughout the trial. Discussion This study will be the first placebo-controlled RCT to assess whether SYKFT plus irbesartan will have beneficial effects on enhancing overall response rate (ORR), changing DN staging, improving clinical symptoms, and reducing the frequency of AEs for DN

  17. Impact of Community Based Peer Support in Type 2 Diabetes: A Cluster Randomised Controlled Trial of Individual and/or Group Approaches

    PubMed Central

    Simmons, David; Prevost, A. Toby; Bunn, Chris; Holman, Daniel; Parker, Richard A.; Cohn, Simon; Donald, Sarah; Paddison, Charlotte A. M.; Ward, Candice; Robins, Peter; Graffy, Jonathan

    2015-01-01

    Background Diabetes peer support, where one person with diabetes helps guide and support others, has been proposed as a way to improve diabetes management. We have tested whether different diabetes peer support strategies can improve metabolic and/or psychological outcomes. Methods People with type 2 diabetes (n = 1,299) were invited to participate as either ‘peer’ or ‘peer support facilitator’ (PSF) in a 2x2 factorial randomised cluster controlled trial across rural communities (130 clusters) in England. Peer support was delivered over 8–12 months by trained PSFs, supported by monthly meetings with a diabetes educator. Primary end point was HbA1c. Secondary outcomes included quality of life, diabetes distress, blood pressure, waist, total cholesterol and weight. Outcome assessors and investigators were masked to arm allocation. Main factors were 1:1 or group intervention. Analysis was by intention-to-treat adjusting for baseline. Results The 4 arms were well matched (Group n = 330, 1:1(individual) n = 325, combined n = 322, control n = 322); 1035 (79•7%) completed the mid-point postal questionnaire and 1064 (81•9%) had a final HbA1c. A limitation was that although 92.6% PSFs and peers were in telephone contact, only 61.4% of intervention participants attended a face to face session. Mean baseline HbA1c was 57 mmol/mol (7•4%), with no significant change across arms. Follow up systolic blood pressure was 2•3mm Hg (0.6 to 4.0) lower among those allocated group peer-support and 3•0mm Hg (1.1 to 5.0) lower if the group support was attended at least once. There was no impact on other outcomes by intention to treat or significant differences between arms in self-reported adherence or medication. Conclusions Group diabetes peer support over 8–12 months was associated with a small improvement in blood pressure but no other significant outcomes. Long term benefits should be investigated. Trial Registration ISRCTN.com ISRCTN6696362166963621 PMID

  18. Effects of a Flaxseed-Derived Lignan Supplement in Type 2 Diabetic Patients: A Randomized, Double-Blind, Cross-Over Trial

    PubMed Central

    Pan, An; Sun, Jianqin; Chen, Yanqiu; Ye, Xingwang; Li, Huaixing; Yu, Zhijie; Wang, Yanfang; Gu, Wenjia; Zhang, Xinyi; Chen, Xiafei; Demark-Wahnefried, Wendy; Liu, Yong; Lin, Xu

    2007-01-01

    Background Flaxseed consumption has been shown to improve blood lipids in humans and flaxseed-derived lignan has been shown to enhance glycemic control in animals. The study aimed to investigate the effect of a flaxseed-derived lignan supplement on glycemic control, lipid profiles and insulin sensitivity in type 2 diabetic patients. Methodology/Principal Findings This was a randomized, double-blind, placebo-controlled, cross-over trial and it was conducted between April and December 2006 in Shanghai, China. Seventy-three type 2 diabetic patients with mild hypercholesterolemia were enrolled into the study. Patients were randomized to supplementation with flaxseed-derived lignan capsules (360 mg lignan per day) or placebo for 12 weeks, separated by an 8-week wash-out period. HbA1c, lipid profiles, insulin resistance index and inflammatory factors were measured. Sixty-eight completed the study and were included in the analyses. The lignan supplement significantly improved glycemic control as measured by HbA1c (-0.10±0.65 % vs. 0.09±0.52 %, P = 0.001) compared to placebo; however, no significant changes were observed in fasting glucose and insulin concentrations, insulin resistance and blood lipid profiles. Urinary excretion of lignan metabolites (enterodiol and enterolactone) was significantly higher after the lignan supplement intervention compared to baseline (14.2±18.1 vs. 1.2±2.4 µg/mL, P<0.001). Data also suggested minimal competition between lignan and isoflavones for bioavailability when measured by the excretion concentrations. Conclusions/Significance Daily lignan supplementation resulted in modest, yet statistically significant improvements in glycemic control in type 2 diabetic patients without apparently affecting fasting glucose, lipid profiles and insulin sensitivity. Further studies are needed to validate these findings and explore the efficacy of lignans on type 2 diabetes. Trial Registration ClinicalTrials.gov NCT00363233 PMID:17987126

  19. Randomized Controlled Trial of Insulin Supplementation for Correction of Bedtime Hyperglycemia in Hospitalized Patients With Type 2 Diabetes

    PubMed Central

    Vellanki, Priyathama; Bean, Rachel; Oyedokun, Festus A.; Pasquel, Francisco J.; Smiley, Dawn; Farrokhi, Farnoosh; Newton, Christopher; Peng, Limin

    2015-01-01

    OBJECTIVE Clinical guidelines recommend point-of-care glucose testing and the use of supplemental doses of rapid-acting insulin before meals and at bedtime for correction of hyperglycemia. The efficacy and safety of this recommendation, however, have not been tested in the hospital setting. RESEARCH DESIGN AND METHODS In this open-label, randomized controlled trial, 206 general medicine and surgery patients with type 2 diabetes treated with a basal-bolus regimen were randomized to receive either supplemental insulin (n = 106) at bedtime for blood glucose (BG) >7.8 mmol/L or no supplemental insulin (n = 100) except for BG >19.4 mmol/L. Point-of-care testing was performed before meals, at bedtime, and at 3:00 a.m. The primary outcome was the difference in fasting BG. In addition to the intention-to-treat analysis, an as-treated analysis was performed where the primary outcome was analyzed for only the bedtime BG levels between 7.8 and 19.4 mmol/L. RESULTS There were no differences in mean fasting BG for the intention-to-treat (8.8 ± 2.4 vs. 8.6 ± 2.2 mmol/L, P = 0.76) and as-treated (8.9 ± 2.4 vs. 8.8 ± 2.4 mmol/L, P = 0.92) analyses. Only 66% of patients in the supplement and 8% in the no supplement groups received bedtime supplemental insulin. Hypoglycemia (BG <3.9 mmol/L) did not differ between groups for either the intention-to-treat (30% vs. 26%, P = 0.50) or the as-treated (4% vs. 8%, P = 0.37) analysis. CONCLUSIONS The use of insulin supplements for correction of bedtime hyperglycemia was not associated with an improvement in glycemic control. We conclude that routine use of bedtime insulin supplementation is not indicated for management of inpatients with type 2 diabetes. PMID:25665812

  20. Effect of Pentoxifylline on Renal Function and Urinary Albumin Excretion in Patients with Diabetic Kidney Disease: The PREDIAN Trial

    PubMed Central

    Mora-Fernández, Carmen; Muros de Fuentes, Mercedes; Chahin, Jesús; Méndez, María L.; Gallego, Eduardo; Macía, Manuel; del Castillo, Nieves; Rivero, Antonio; Getino, María A.; García, Patricia; Jarque, Ana; García, Javier

    2015-01-01

    Diabetic kidney disease (DKD) is the leading cause of ESRD. We conducted an open-label, prospective, randomized trial to determine whether pentoxifylline (PTF), which reduces albuminuria, in addition to renin-angiotensin system (RAS) blockade, can slow progression of renal disease in patients with type 2 diabetes and stages 3–4 CKD. Participants were assigned to receive PTF (1200 mg/d) (n=82) or to a control group (n=87) for 2 years. All patients received similar doses of RAS inhibitors. At study end, eGFR had decreased by a mean±SEM of 2.1±0.4 ml/min per 1.73 m2 in the PTF group compared with 6.5±0.4 ml/min per 1.73 m2 in the control group, with a between-group difference of 4.3 ml/min per 1.73 m2 (95% confidence interval [95% CI], 3.1 to 5.5 ml/min per 1.73 m2; P<0.001) in favor of PTF. The proportion of patients with a rate of eGFR decline greater than the median rate of decline (0.16 ml/min per 1.73 m2 per month) was lower in the PTF group than in the control group (33.3% versus 68.2%; P<0.001). Percentage change in urinary albumin excretion was 5.7% (95% CI, −0.3% to 11.1%) in the control group and −14.9% (95% CI, −20.4% to −9.4%) in the PTF group (P=0.001). Urine TNF-α decreased from a median 16 ng/g (interquartile range, 11–20.1 ng/g) to 14.3 ng/g (interquartile range, 9.2–18.4 ng/g) in the PTF group (P<0.01), with no changes in the control group. In this population, addition of PTF to RAS inhibitors resulted in a smaller decrease in eGFR and a greater reduction of residual albuminuria. PMID:24970885

  1. Feasibility of Pairing Behavioral Activation With Exercise for Women With Type 2 Diabetes and Depression: The Get It Study Pilot Randomized Controlled Trial.

    PubMed

    Schneider, Kristin L; Panza, Emily; Handschin, Barbara; Ma, Yunsheng; Busch, Andrew M; Waring, Molly E; Appelhans, Bradley M; Whited, Matthew C; Keeney, Jacey; Kern, Daniel; Blendea, Mihaela; Ockene, Ira; Pagoto, Sherry L

    2016-03-01

    Major depressive disorder is often comorbid with diabetes and associated with worse glycemic control. Exercise improves glycemic control and depression, and thus could be a parsimonious intervention for patients with comorbid diabetes and major depression. Because patients with diabetes and comorbid depression are often sedentary and lack motivation to exercise, we developed a group exercise intervention that integrates strategies from behavioral activation therapy for depression to increase motivation for and enjoyment of exercise. We conducted a 6-month pilot randomized controlled trial to test the feasibility of the behavioral activation exercise intervention (EX) for women with diabetes and depression. Of the 715 individuals who contacted us about the study, 29 participants were randomized to the EX condition or an enhanced usual care condition (EUC), which represents 4.1% of participants who initially contacted us. Inclusion criteria made recruitment challenging and limits the feasibility of recruiting women with diabetes and depression for a larger trial of the intervention. Retention was 96.5% and 86.2% at 3 and 6months. Participants reported high treatment acceptability; use of behavioral activation strategies and exercise class attendance was acceptable. No condition differences were observed for glycemic control, depressive symptoms, and physical activity, though depressive symptoms and self-reported physical activity improved over time. Compared to participants in the EUC condition, participants in the EX condition reported greater exercise enjoyment and no increase in avoidance behavior over time. Using behavioral activation strategies to increase exercise is feasible in a group exercise setting. However, whether these strategies can be delivered in a less intensive manner to a broader population of sedentary adults, for greater initiation and maintenance of physical activity, deserves further study. PMID:26956652

  2. Metformin intervention in obese non-diabetic patients with breast cancer: phase II randomized, double-blind, placebo-controlled trial.

    PubMed

    Ko, Kwang-Pil; Ma, Seung Hyun; Yang, Jae-Jeong; Hwang, Yunji; Ahn, Choonghyun; Cho, Young-Min; Noh, Dong-Young; Park, Byung-Joo; Han, Wonshik; Park, Sue K

    2015-09-01

    Previous observational studies have suggested that metformin in diabetes patients may reduce breast cancer risk more than the reductions from other anti-diabetes medications. This randomized, double-blind, placebo-controlled trial was performed to evaluate the efficacy of metformin for controlling physical and metabolic profiles related to prognosis and adverse events in non-diabetic breast cancer patients. Female breast cancer patients (N = 105), at least 6 months post-mastectomy, with obesity (≥25 kg/m(2)) and/or pre-diabetes (fasting blood sugar levels ≥100 mg/dL), were randomly assigned to three groups (placebo, metformin 500 mg, and metformin 1000 mg) stratified by tamoxifen use. A linear mixed model for repeated measurements among three groups and ANOVA for profile differences during 6 months of treatment were used for the intention-to-treat analysis. The metformin 1000 mg group had a significantly greater decline in glucose and HbA1c levels between treatment weeks 0 and 6 month (p = 0.008 and 0.009, respectively), and the declines increased with an increase in body mass index (BMI) level (p interaction with BMI = 0.007 and 0.067, respectively). A marginally significant different effect from the metformin 1000 mg treatment was detected for glucose and HbA1c levels (p interaction = 0.084 and 0.063, respectively) in the intention-to-treat analysis. Metformin 1000 mg treatment had a favorable effect on controlling glucose and HbA1C levels in obese non-diabetic breast cancer patients, indicating prognostic importance. Further trials are needed to elucidate the risk-benefit ratio of long-term use of metformin. PMID:26293146

  3. Effect of Probiotic Fermented Milk (Kefir) on Glycemic Control and Lipid Profile In Type 2 Diabetic Patients: A Randomized Double-Blind Placebo-Controlled Clinical Trial

    PubMed Central

    OSTADRAHIMI, Alireza; TAGHIZADEH, Akbar; MOBASSERI, Majid; FARRIN, Nazila; PAYAHOO, Laleh; BEYRAMALIPOOR GHESHLAGHI, Zahra; VAHEDJABBARI, Morteza

    2015-01-01

    Background: Diabetes is a global health problem in the world. Probiotic food has anti-diabetic property. The aim of this trial was to determine the effect of probiotic fermented milk (kefir) on glucose and lipid profile control in patients with type 2 diabetes mellitus. Methods: This randomized double-blind placebo-controlled clinical trial was conducted on 60 diabetic patients aged 35 to 65 years.Patients were randomly and equally (n=30) assigned to consume either probiotic fermented milk (kefir) or conventional fermented milk (dough) for 8 weeks. Probiotic group consumed 600 ml/day probiotic fermented milk containing Lactobacillus casei, Lactobacillus acidophilus and Bifidobacteria and control group consumed 600 ml/day conventional fermented milk.Blood samples tested for fasting blood glucose, HbA1C, triglyceride (TG), total cholesterol, HDL-C and LDL-C at the baseline and end of the study. Results: The comparison of fasting blood glucose between two groups after intervention was statistically significant (P=0.01). After intervention, reduced HbA1C compared with the baseline value in probiotic fermented milk group was statistically significant (P=0.001), also the HbA1C level significantly decreased in probiotic group in comparison with control group (P=0.02) adjusting for serum levels of glucose, baseline values of HbA1c and energy intake according to ANCOVA model. Serum triglyceride, total cholesterol, LDL-cholesterol and HDL- cholesterol levels were not shown significant differences between and within the groups after intervention. Conclusion: Probiotic fermented milk can be useful as a complementary or adjuvant therapy in the treatment of diabetes. PMID:25905057

  4. Technology-facilitated depression care management among predominantly Latino diabetes patients within a public safety net care system: comparative effectiveness trial design.

    PubMed

    Wu, Shinyi; Ell, Kathleen; Gross-Schulman, Sandra G; Sklaroff, Laura Myerchin; Katon, Wayne J; Nezu, Art M; Lee, Pey-Jiuan; Vidyanti, Irene; Chou, Chih-Ping; Guterman, Jeffrey J

    2014-03-01

    Health disparities in minority populations are well recognized. Hispanics and Latinos constitute the largest ethnic minority group in the United States; a significant proportion receives their care via a safety net. The prevalence of diabetes mellitus and comorbid depression is high among this group, but the uptake of evidence-based collaborative depression care management has been suboptimal. The study design and baseline characteristics of the enrolled sample in the Diabetes-Depression Care-management Adoption Trial (DCAT) establishes a quasi-experimental comparative effectiveness research clinical trial aimed at accelerating the adoption of collaborative depression care in safety net clinics. The study was conducted in collaboration with the Los Angeles County Department of Health Services at eight county-operated clinics. DCAT has enrolled 1406 low-income, predominantly Hispanic/Latino patients with diabetes to test a translational model of depression care management. This three-group study compares usual care with a collaborative care team support model and a technology-facilitated depression care model that provides automated telephonic depression screening and monitoring tailored to patient conditions and preferences. Call results are integrated into a diabetes disease management registry that delivers provider notifications, generates tasks, and issues critical alerts. All subjects receive comprehensive assessments at baseline, 6, 12, and 18 months by independent English-Spanish bilingual interviewers. Study outcomes include depression outcomes, treatment adherence, satisfaction, acceptance of assessment and monitoring technology, social and economic stress reduction, diabetes self-care management, health care utilization, and care management model cost and cost-effectiveness comparisons. DCAT's goal is to optimize depression screening, treatment, follow-up, outcomes, and cost savings to reduce health disparities. PMID:24215775

  5. The use of weighted health-related Quality of Life scores in people with diabetic macular oedema at baseline in a randomized clinical trial

    PubMed Central

    Scanlon, P H; Loftus, J; Starita, C; Stratton, I M

    2015-01-01

    Aims To examine the relationship between visual acuity in each eye and Quality of Life (QoL) outcomes in people with diabetic macular oedema. Methods Cross sectional retrospective analysis of data collected at baseline in 289 people entered into a randomized clinical trial with diabetic macular oedema which investigated the safety and efficacy of a vascular endothelial growth factor inhibitor, pegaptanib sodium. At the baseline visit, visual acuity was measured through refraction and using retro-illuminated modified Early Treatment Diabetic Retinopathy Study Log MAR charts, and patient health-related QoL was determined using the European Quality of Life EQ–5D–3L and the Visual Functioning Questionnaire–25 (NEI–VFQ25). A regression analysis with QoL score from each vision-related domain as the dependent variable was fitted using linear and quadratic terms of the better and worse eye, age, gender, adjusted for number of concurrent conditions, ethnicity and level of diabetes control. Results For all vision-related QoL domains from NEI–VFQ25 and EQ–5D–3L except ocular pain, both visual acuity in the better-seeing and the worse-seeing eye gave a significant increase in correlation coefficient over that obtained from clinical and demographic data. The NEI–VFQ25 correlation was most closely associated with a weighted visual acuity measure of 0.75 in the better and 0.25 in the worse eye or 0.60 in the better and 0.40 in the worse eye. Conclusions We recommend that a weighted visual acuity measure from both eyes is considered in future diabetic macular oedema trials. PMID:25251842

  6. Effects of an aquatic physical exercise program on glycemic control and perinatal outcomes of gestational diabetes: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Gestational diabetes mellitus (GDM) is increasing worldwide and has been associated with adverse perinatal outcomes and high risk for chronic disease both for the mother and for the child. Physical exercise is feasible for diabetic pregnant women and contributes to better glycemic control and to a decrease in adverse perinatal outcomes. However, there are no randomized controlled trials (RCT) assessing the effects of aquatic physical exercise on GDM control and adverse maternal and fetal outcomes. Methods/Design An RCT will be conducted at Instituto de Medicina Integral Prof Fernando Figueira (IMIP), Brazil. A total of 72 pregnant women will be studied; 36 gestational diabetics will undergo an aquatic physical exercise program in a thermal pool, 3 times per week over 2 months. The primary endpoint will be glucose level control and use of insulin; secondary endpoints will be the following maternal and fetal outcomes: weight gain during pregnancy, blood pressure, pre-eclampsia diagnosis, intrauterus growth restriction, preterm birth, Cesarean section, macrosomia and maternal or neonatal intensive care admission. Endpoints between intervention and control group will analyzed by t test for unpaired data and χ2 test, and the level of significance will set at <0.05. Discussion The physical proprieties of water make aquatic exercises ideal for pregnant women. An aquatic physical exercise program developed for GDM women will be trialed in a thermal pool and under the supervision of physiotherapist to ensure compliance. It is expected that this study will provide evidence as to the effect of aquatic physical exercise on GDM control. Trial registration ClinicalTrial.gov, NCT01940003. PMID:24245914

  7. Semi-individualised Chinese medicine treatment as an adjuvant management for diabetic nephropathy: a pilot add-on, randomised, controlled, multicentre, open-label pragmatic clinical trial

    PubMed Central

    Chan, Kam Wa; Ip, Tai Pang; Kwong, Alfred Siu Kei; Lui, Sing Leung; Chan, Gary Chi Wang; Cowling, Benjamin John; Yiu, Wai Han; Wong, Dickson Wai Leong; Liu, Yang; Feng, Yibin; Tan, Kathryn Choon Beng; Chan, Loretta Yuk Yee; Leung, Joseph Chi Kam; Lai, Kar Neng; Tang, Sydney Chi Wai

    2016-01-01

    Introduction Diabetes mellitus and diabetic nephropathy (DN) are prevalent and costly to manage. DN is the leading cause of end-stage kidney disease. Conventional therapy blocking the renin–angiotensin system has only achieved limited effect in preserving renal function. Recent observational data show that the use of Chinese medicine (CM), a major form of traditional medicine used extensively in Asia, could reduce the risk of end-stage kidney disease. However, existing clinical practice guidelines are weakly evidence-based and the effect of CM remains unclear. This trial explores the effect of an existing integrative Chinese–Western medicine protocol for the management of DN. Objective To optimise parameters and assess the feasibility for a subsequent phase III randomised controlled trial through preliminary evaluation on the effect of an adjuvant semi-individualised CM treatment protocol on patients with type 2 diabetes with stages 2–3 chronic kidney disease and macroalbuminuria. Methods and analysis This is an assessor-blind, add-on, randomised, controlled, parallel, multicentre, open-label pilot pragmatic clinical trial. 148 patients diagnosed with DN will be recruited and randomised 1:1 to a 48-week additional semi-individualised CM treatment programme or standard medical care. Primary end points are the changes in estimated glomerular filtration rate and spot urine albumin-to-creatinine ratio between baseline and treatment end point. Secondary end points include fasting blood glucose, glycated haemoglobin, brain natriuretic peptide, fasting insulin, C peptide, fibroblast growth factor 23, urinary monocyte chemotactic protein-1, cystatin C, nephrin, transforming growth factor-β1 and vascular endothelial growth factor. Adverse events are monitored through self-completed questionnaire and clinical visits. Outcomes will be analysed by regression models. Enrolment started in July 2015. Ethics and registration This protocol is approved by the Institutional

  8. Cost-Effectiveness of Percutaneous Coronary Intervention with Drug Eluting Stents versus Bypass Surgery for Patients with Diabetes and Multivessel Coronary Artery Disease: Results from the FREEDOM Trial

    PubMed Central

    Magnuson, Elizabeth A.; Farkouh, Michael E.; Fuster, Valentin; Wang, Kaijun; Vilain, Katherine; Li, Haiyan; Appelwick, Jaime; Muratov, Victoria; Sleeper, Lynn A.; Boineau, Robin; Abdallah, Mouin; Cohen, David J.

    2013-01-01

    Background Studies from the balloon angioplasty and bare metal stent eras have demonstrated that CABG is cost-effective compared with PCI for patients undergoing multivessel coronary revascularization—particularly among patients with complex CAD or diabetes. Whether these results apply in the drug-eluting stent (DES) era is unknown. Methods and Results Between 2005 and 2010, 1900 patients with diabetes and multivessel CAD were randomized to PCI with DES (DES-PCI; n=953) or CABG (n=947). Costs were assessed from the perspective of the U.S. health care system. Health state utilities were assessed using the EuroQOL. A patient-level microsimulation model based on U.S. life-tables and in-trial results was used to estimate lifetime cost-effectiveness. Although initial procedural costs were lower for CABG, total costs for the index hospitalization were $8,622/patient higher. Over the next 5 years, follow-up costs were higher with PCI, owing to more frequent repeat revascularization and higher outpatient medication costs. Nonetheless, cumulative 5-year costs remained $3,641/patient higher with CABG. Although there were only modest gains in survival with CABG during the trial period, when the in-trial results were extended to a lifetime horizon, CABG was projected to be economically attractive relative to DES-PCI, with substantial gains in both life expectancy and quality-adjusted life expectancy and incremental cost-effectiveness ratios <$10,000 per life-year or quality-adjusted life-year gained across a broad range of assumptions regarding the effect of CABG on post-trial survival and costs. Conclusions Despite higher initial costs, CABG is a highly cost-effective revascularization strategy compared with DES-PCI for patients with diabetes and multivessel CAD. PMID:23277307

  9. Student Affairs and the Bicentennial

    ERIC Educational Resources Information Center

    Dinniman, Andrew E.

    1974-01-01

    Student Affairs professionals have an active role to play in our nation's anniversary celebration, according to the author. In this article, he describes briefly some Bicentennial programs at different universities and colleges throughout the U.S. (Author/HMV)

  10. House Committee on Veterans' Affairs

    MedlinePlus

    Skip to main content House Committee on Veterans Affairs Search form Search Main menu About Chair History and Jurisdiction History of the CHOB Internship Opportunities Membership Rules and Publications Hearings Archived ...

  11. Judicial Affairs and the Future.

    ERIC Educational Resources Information Center

    Pavela, Gary

    1996-01-01

    American colleges and universities will play an increasingly important role in revitalizing a national sense of identity and community. Judicial affairs offices can contribute to that process by helping students define and protect values essential to community life. (Author)

  12. The effects of vitamin D2 or D3 supplementation on glycaemic control and related metabolic parameters in people at risk of type 2 diabetes: protocol of a randomised double-blind placebo-controlled trial

    PubMed Central

    2013-01-01

    Background The global prevalence of type 2 diabetes is increasing. Effective strategies to address this public health challenge are currently lacking. A number of epidemiological studies have reported associations between low concentrations of 25-hydroxy vitamin D and the incidence of diabetes, but a causal link has not been established. We investigate the effect of vitamin D supplementation on the metabolic status of individuals at increased risk of developing type 2 diabetes. Methods/design In a randomised double-blind placebo-controlled trial individuals identified as having a high risk of type 2 diabetes (non-diabetic hyperglycaemia or positive diabetes risk score) are randomised into one of three groups and given 4 doses of either placebo, or 100,000 IU Vitamin D2 (ergocalciferol) or 100,000 IU Vitamin D3 (cholecalciferol) at monthly intervals. The primary outcome measure is the change in glycated haemoglobin level between baseline and 4 months. Secondary outcome measures include blood pressure, lipid levels, apolipoproteins, highly sensitive C-reactive protein, parathyroid hormone (PTH) and safety of supplementation. and C-reactive protein. The trial is being conducted at two sites (London and Cambridge, U.K.) and a total of 342 participants are being recruited. Discussion Trial data examining whether supplementation of vitamin D improves glycaemic status and other metabolic parameters in people at risk of developing type 2 diabetes are sparse. This trial will evaluate the causal role of vitamin D in hyperglycaemia and risk of type 2 diabetes. Specific features of this trial include recruitment of participants from different ethnic groups, investigation of the relative effectiveness and safety of vitamin D2 and D3 and an evidence based approach to determination of the dose of supplementation. Trial registration EudraCT2009-011264-11; ISRCTN86515510 PMID:24152375

  13. DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial – study protocol

    PubMed Central

    2013-01-01

    Background Gestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women. Methods/design Pregnant women at risk of GDM (BMI≥29 (kg/m2)) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation. After giving informed consent, women without GDM will be included (based on IADPSG criteria: fasting glucose<5.1mmol; 1 hour glucose <10.0 mmol; 2 hour glucose <8.5 mmol) and randomized to one of the 8 intervention arms using a 2×(2×2) factorial design: (1) healthy eating (HE), 2) physical activity (PA), 3) HE+PA, 4) control, 5) HE+PA+vitamin D, 6) HE+PA+placebo, 7) vitamin D alone, 8) placebo alone), pre-stratified for each site. In total, 880 women will be included with 110 women allocated to each arm. Between entry and 35 weeks of gestation, women allocated to a lifestyle intervention will receive 5 face-to-face, and 4 telephone coaching sessions, based on the principles of motivational interviewing. The lifestyle intervention includes a discussion about the risks of GDM, a weight gain target <5kg and either 7 healthy eating ‘messages’ and/or 5 physical activity ‘messages’ depending on randomization. Fidelity is monitored by the use of a personal digital assistance (PDA) system. Participants randomized to the vitamin D intervention receive either 1600 IU vitamin D or placebo for daily intake until delivery. Data is collected at baseline measurement, at 24–28 weeks, 35–37 weeks of gestation and after delivery. Primary outcome measures are gestational weight gain, fasting glucose and insulin sensitivity, with a range of obstetric secondary outcome measures including birth weight. Discussion DALI is a unique Europe-wide randomised controlled trial, which will gain insight into preventive measures against the development of GDM in overweight and obese women. Trial registration ISRCTN70595832 PMID:23829946

  14. Treatment of patients with diabetic peripheral neuropathic pain in China: a double-blind randomised trial of duloxetine vs. placebo

    PubMed Central

    Gao, Y; Guo, X; Han, P; Li, Q; Yang, G; Qu, S; Yue, L; Wang, C-N; Skljarevski, V; Dueñas, H; Raskin, J; Gu, L

    2015-01-01

    Background Duloxetine has been approved in the United States, European Union and some Asian countries for the treatment of diabetic peripheral neuropathic pain (DPNP). We assessed the efficacy and safety of duloxetine (60 mg once daily) compared with placebo in Chinese patients suffering from DPNP. Methods This was a phase 3, multicenter, randomised, double-blind, parallel, placebo-controlled, 12-week trial of the treatment of DPNP with duloxetine. Subjects were male and female outpatients ≥ 18 years of age with DPNP, as assessed by the Michigan Neuropathy Screening Instrument, and had a rating of ≥ 4 on the Brief Pain Inventory-Modified Short Form-Severity weekly average pain item. The primary efficacy measure was the reduction in pain severity from baseline to 12 weeks, as measured by the weekly mean of 24-h average pain ratings recorded in the patient’s diary. Mean changes from baseline in efficacy measures were analysed by a restricted maximum likelihood-based, mixed-effects model repeated measures approach and by analysis of covariance. Results Of the 405 patients randomised, 203 patients were assigned to duloxetine 60 mg once daily and 202 patients were assigned to placebo. Duloxetine-treated patients showed significantly greater pain relief on 24-h average pain ratings compared with placebo-treated patients each week of the 12-week study period [week 12: least squares (LS) mean change duloxetine: −2.40, placebo: −1.97; LS mean change difference (95% confidence interval) = −0.43 (−0.82, −0.04), p = 0.030]. Compared with placebo, patients treated with duloxetine experienced higher rates of nausea (p = 0.010), somnolence (p < 0.001) and asthenia (p = 0.002). Conclusions Duloxetine-treated patients showed significantly greater pain relief compared with placebo-treated patients over the 12-week study period. Duloxetine was shown in Chinese patients to have a safety profile similar to that found in previous duloxetine trials. PMID

  15. Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema

    PubMed Central

    Elman, Michael J.; Aiello, Lloyd Paul; Beck, Roy W.; Bressler, Neil M.; Bressler, Susan B.; Edwards, Allison R.; Ferris, Frederick L.; Friedman, Scott M.; Glassman, Adam R.; Miller, Kellee M.; Scott, Ingrid U.; Stockdale, Cynthia R.; Sun, Jennifer K.

    2010-01-01

    Objective Evaluate intravitreal 0.5 mg ranibizumab or 4 mg triamcinolone combined with focal/grid laser compared with focal/grid laser alone for treatment of diabetic macular edema (DME). Design Multicenter, randomized clinical trial. Participants A total of 854 study eyes of 691 participants with visual acuity (approximate Snellen equivalent) of 20/32 to 20/320 and DME involving the fovea. Methods Eyes were randomized to sham injection + prompt laser (n=293), 0.5 mg ranibizumab + prompt laser (n=187), 0.5 mg ranibizumab + deferred (≥24 weeks) laser (n=188), or 4 mg triamcinolone + prompt laser (n=186). Retreatment followed an algorithm facilitated by a web-based, real-time data-entry system. Main Outcome Measures Best-corrected visual acuity and safety at 1 year. Results The 1-year mean change (±standard deviation) in the visual acuity letter score from baseline was significantly greater in the ranibizumab + prompt laser group (+9±11, P<0.001) and ranibizumab + deferred laser group (+9±12, P<0.001) but not in the triamcinolone + prompt laser group (+4±13, P=0.31) compared with the sham + prompt laser group (+3±13). Reduction in mean central subfield thickness in the triamcinolone + prompt laser group was similar to both ranibizumab groups and greater than in the sham + prompt laser group. In the subset of pseudophakic eyes at baseline (n=273), visual acuity improvement in the triamcinolone + prompt laser group appeared comparable to that in the ranibizumab groups. No systemic events attributable to study treatment were apparent. Three eyes (0.8%) had injection-related endophthalmitis in the ranibizumab groups, whereas elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone + prompt laser group. Two-year visual acuity outcomes were similar to 1-year outcomes. Conclusions Intravitreal ranibizumab with prompt or deferred laser is more effective through at least 1 year compared with prompt laser alone for the treatment of DME

  16. Management of type 2 diabetes in China: the Happy Life Club, a pragmatic cluster randomised controlled trial using health coaches

    PubMed Central

    Browning, Colette; Chapman, Anna; Yang, Hui; Liu, Shuo; Zhang, Tuohong; Enticott, Joanne C; Thomas, Shane A

    2016-01-01

    Objective To assess the effectiveness of a coach-led motivational interviewing (MI) intervention in improving glycaemic control, as well as clinical, psychosocial and self-care outcomes of individuals with type 2 diabetes mellitus (T2DM) compared with usual care. Design Pragmatic cluster randomised controlled trial (RCT). Setting Community Health Stations (CHSs) in Fengtai district, Beijing, China. Participants Of the 41 randomised CHSs (21 intervention and 20 control), 21 intervention CHSs (372 participants) and 18 control CHSs (296 participants) started participation. Intervention Intervention participants received telephone and face-to-face MI health coaching in addition to usual care from their CHS. Control participants received usual care only. Medical fees were waived for both groups. Outcome measures Outcomes were assessed at baseline, 6 and 12 months. Primary outcome measure was glycated haemoglobin (HbA1c). Secondary outcomes included a suite of anthropometric, blood pressure (BP), fasting blood, psychosocial and self-care measures. Results At 12 months, no differential treatment effect was found for HbA1c (adjusted difference 0.02, 95% CI −0.40 to 0.44, p=0.929), with both treatment and control groups showing significant improvements. However, two secondary outcomes: psychological distress (adjusted difference −2.38, 95% CI −4.64 to −0.12, p=0.039) and systolic BP (adjusted difference −3.57, 95% CI −6.08 to −1.05, p=0.005) were robust outcomes consistent with significant differential treatment effects, as supported in sensitivity analyses. Interestingly, in addition to HbA1c, both groups displayed significant improvements in triglycerides, LDL cholesterol and HDL cholesterol. Conclusions In line with the current Chinese primary healthcare reform, this study is the first large-scale cluster RCT to be implemented within real-world CHSs in China, specifically addressing T2DM. Although a differential treatment effect was not observed for Hb

  17. The Irish DAFNE Study Protocol: A cluster randomised trial of group versus individual follow-up after structured education for Type 1 diabetes

    PubMed Central

    Dinneen, Seán F; O' Hara, Mary Clare; Byrne, Molly; Newell, John; Daly, Lisa; O' Shea, Donal; Smith, Diarmuid

    2009-01-01

    Background Structured education programmes for individuals with Type 1 diabetes have become a recognised means of delivering the knowledge and skills necessary for optimal self-management of the condition. The Dose Adjustment for Normal Eating (DAFNE) programme has been shown to improve biomedical (HbA1c and rates of severe hypoglycaemia) and psychosocial outcomes for up to 12 months following course delivery. The optimal way to support DAFNE graduates and maintain the benefits of the programme has not been established. We aimed to compare 2 different methods of follow-up of DAFNE graduates in a pragmatic clinical trial delivered in busy diabetes clinics on the island of Ireland. Methods Six participating centres were cluster randomised to deliver either group follow-up or a return to traditional one-to-one clinic visits. In the intervention arm group follow-up was delivered at 6 and 12 months post DAFNE training according to a curriculum developed for the study. In the control arm patients were seen individually in diabetes clinics as part of routine care. Study outcomes included HbA1c levels, self-reported rates of severe hypoglycaemia, body weight and measures of diabetes wellbeing and quality of life. These were measured at 6, 12 and 18 months after recruitment. Generalisability (external validity) was maximised by recruiting study participants from existing DAFNE waiting lists in each centre, by using broad inclusion criteria (including HbA1c values less than 13 percent with no lower limit) and by using existing clinic staff to deliver the training and follow-up. Internal validity and treatment fidelity were maximised by quality assuring the training of all DAFNE educators, by external peer review of the group follow-up sessions and by striving for full attendance at follow-up visits. Assays of HbA1c were undertaken in a central laboratory. Discussion This pragmatic clinical trial evaluating group follow-up after a structured education programme has been

  18. Aspirin for Primary Prevention of Cardiovascular Events: Meta-Analysis of Randomized Controlled Trials and Subgroup Analysis by Sex and Diabetes Status

    PubMed Central

    Zhang, Yan; Chen, Sijing; Yang, Wei; Bao, Wei; Rong, Ying; Yu, Xuefeng; Hu, Frank B.; Liu, Liegang

    2014-01-01

    Objective To evaluate the benefits and harms of aspirin for the primary prevention of CVD and determine whether the effects vary by sex and diabetes status. Methods We searched Medline, Embase, and Cochrane databases for randomized controlled trials comparing the effects of aspirin with placebo or control in people with no pre-existing CVD. Two investigators independently extracted data and assessed the study quality. Analyses were performed using Stata version 12. Results Fourteen trials (107,686 participants) were eligible. Aspirin was associated with reductions in major cardiovascular events (risk ratio, 0.90; 95% confidence interval, 0.85–0.95), myocardial infarction (0.86; 0.75–0.93), ischemic stroke (0.86; 0.75–0.98) and all-cause mortality (0.94; 0.89–0.99). There were also increases in hemorrhagic stroke (1.34; 1.01–1.79) and major bleeding (1.55; 1.35–1.78) with aspirin. The number needed to treat to prevent 1 major cardiovascular event over a mean follow-up of 6.8 years was 284. By comparison, the numbers needed to harm to cause 1 major bleeding is 299. In subgroup analyses, pooled results demonstrated a reduction in myocardial infarction among men (0.71; 0.59–0.85) and ischemic stroke among women (0.77; 0.63–0.93). Aspirin use was associated with a reduction (0.65; 0.51–0.82) in myocardial infarction among diabetic men. In meta-regression analyses, the results suggested that aspirin therapy might be associated with a decrease in stroke among diabetic women and a decrease in MI among diabetic men and risk reductions achieved with low doses (75 mg/day) were as large as those obtained with higher doses (650 mg/day). Conclusions The use of low-dose aspirin was beneficial for primary prevention of CVD and the decision regarding an aspirin regimen should be made on an individual patient basis. The effects of aspirin therapy varied by sex and diabetes status. A clear benefit of aspirin in the primary prevention of CVD in people with diabetes

  19. Effects of Low Glycemic Index Diets on Gestational Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Clinical Trials.

    PubMed

    Wei, Jinhua; Heng, Weijun; Gao, Jianbo

    2016-05-01

    Studies of the effects of low glycemic index (LGI) diets on gestational diabetes mellitus (GDM) have reported conflicting findings.The aim of the study was to evaluate the results of randomized controlled trials (RCTs) that investigated the effects of LGI diets with and without added dietary fiber (DF) on maternal and neonatal outcomes in GDM patients.We searched the MEDLINE, EMBASE, EBSCO, Springer, Ovid, and Cochrane Library databases for studies of the effects of LGI diets in GDM patients. We performed a meta-analysis of the effects of the LGI diets with and without added dietary fiber (DF) on GDM outcomes. Risk ratios (RR) and 95% confidence intervals (CIs) were calculated using random- and fixed-effects models.Five RCTs involving 302 participants were included in our meta-analysis. No statistically significant differences in the risks of cesarean section delivery, large for gestational age, and small for gestational age were observed. The risk of macrosomia in the LGI groups was significantly lower (RR = 0.27; 95% CI: 0.10-0.71; P = 0.008) than that in the control groups. Our subgroup analysis of the effects of DF showed that LGI diets with an increased level of DF, relative to the control diet, reduced the risk of macrosomia beyond that of the LGI diets alone (RR: 0.17 vs 0.47, respectively). The subgroup analysis also showed that LGI diets in which the level of DF was approximately equivalent to that in the control diets significantly reduced the risk of insulin usage (RR = 0.69; 95% CI: 0.52-0.92; P = 0.01).The LGI diets reduced the risk of macrosomia in GDM patients, and LGI diets with added DF reduced the risk of macrosomia further. The LGI diets with levels of DF approximately equivalent to that in the control diets reduced the risk of insulin usage in GDM patients. PMID:27258511

  20. Mineralocorticoid Receptor Antagonist Use in Hospitalized Patients with Heart Failure, Reduced Ejection Fraction, and Diabetes Mellitus (from the EVEREST Trial)

    PubMed Central

    Vaduganathan, Muthiah; Cas, Alessandra Dei; Mentz, Robert J.; Greene, Stephen J.; Khan, Sadiya; Subacius, Haris P.; Chioncel, Ovidiu; Maggioni, Aldo P.; Konstam, Marvin A.; Senni, Michele; Fonarow, Gregg C.; Butler, Javed; Gheorghiade, Mihai

    2014-01-01

    Despite the well-established benefits of mineralocorticoid receptor agonists (MRAs) in heart failure with reduced ejection fraction, safety concerns remain in patients with concomitant diabetes mellitus (DM) because of common renal and electrolyte abnormalities in this population. We analyzed all-cause mortality and composite cardiovascular mortality and HF hospitalization over a median 9.9 months among 1,998 patients in the placebo arm of the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) trial by DM status and discharge MRA use. Of the 750 patients with DM, 59.2% were receiving MRAs compared with 62.5% in the non-DM patients. DM patients not receiving MRAs were older, more likely to be men, with an ischemic heart failure etiology and slightly worse renal function compared with those receiving MRAs. After adjustment for baseline risk factors, among DM patients, MRA use was not associated with either mortality (hazard ratio [HR] 0.93; 95% confidence interval [CI] 0.75 to 1.15) or the composite end point (HR 0.94; 95% CI 0.80 to 1.10). Similar findings were seen in non-DM patients (mortality [HR 1.01; 95% CI 0.84 to 1.22] or the composite end point [HR 0.98; 95% CI 0.85 to 1.13] [p >0.43 for DM interaction]). In conclusion, in-hospital initiation of MRA therapy was low (15% to 20%), and overall discharge MRA use was only 60% (with regional variation), regardless of DM status. There does not appear to be clear, clinically significant in-hospital hemodynamic or even renal differences between those on and off MRA. Discharge MRA use was not associated with postdischarge end points in patients hospitalized for worsening heart failure with reduced ejection fraction and co-morbid DM. DM does not appear to influence the effectiveness of MRA therapy. PMID:25060414

  1. Amoxicillin Plus Metronidazole Therapy for Patients with Periodontitis and Type 2 Diabetes: A 2-year Randomized Controlled Trial.

    PubMed

    Tamashiro, N S; Duarte, P M; Miranda, T S; Maciel, S S; Figueiredo, L C; Faveri, M; Feres, M

    2016-07-01

    The aim of this study was to assess the changes occurring in subgingival biofilm composition and in the periodontal clinical parameters of subjects with periodontitis and type 2 diabetes mellitus (DM) treated by means of scaling and root planing (SRP) only or combined with systemic metronidazole (MTZ) and amoxicillin (AMX). Fifty-eight subjects were randomly assigned to receive SRP only (n = 29) or with MTZ (400 mg/thrice a day [TID]) and AMX (500 mg/TID) (n = 29) for 14 d. Six subgingival plaque samples/subject were analyzed by checkerboard DNA-DNA hybridization for 40 bacterial species at baseline and 3 mo, 1 y, and 2 y posttherapy. At 2 y posttherapy, the antibiotic-treated group harbored lower mean proportions (5.5%) of red complex pathogens than the control group (12.1%) (P < 0.05). The proportions of the Actinomyces species remained stable in the antibiotic group but showed a statistically significant reduction in the control group from 1 to 2 y in subjects achieving a low risk clinical profile for future disease progression (i.e., ≤4 sites with probing depth [PD] ≥5 mm). The test group also had a lower mean number of sites with PD ≥5 mm (3.5 ± 3.4) and a higher percentage of subjects reaching the low risk clinical profile (76%) than the control group (14.7 ± 13.1 and 22%, respectively) (P < 0.05) at 2 y posttreatment. MTZ + AMX intake was the only significant predictor of subjects achieving the low risk at 2 y (odds ratio, 20.9; P = 0.0000). In conclusion, the results of this study showed that the adjunctive use of MTZ + AMX improves the microbiological and clinical outcomes of SRP in the treatment of subjects with generalized chronic periodontitis and type 2 DM up to 2 y (ClinicalTrials.gov NCT02135952). PMID:27013640

  2. Prostate Cancer Research Trial Helps John Spencer Treat His Cancer | NIH MedlinePlus the Magazine

    MedlinePlus

    ... Affairs, both sponsor and conduct clinical trials. Numerous organizations, physicians, medical institutions, foundations, volunteer groups, and pharmaceutical companies also undertake clinical trials. How Can I Find ...

  3. A culturally adapted lifestyle intervention addressing a Middle Eastern immigrant population at risk of diabetes, the MEDIM (impact of Migration and Ethnicity on Diabetes In Malmö): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Studies have shown that lifestyle interventions are effective in preventing or delaying the onset of type 2 diabetes in high-risk patients. However, research on the effectiveness of lifestyle interventions in high-risk immigrant populations with different cultural and socioeconomic backgrounds is scarce. The aim was to design a culturally adapted lifestyle intervention for an immigrant population and to evaluate its effectiveness and cost-effectiveness. Methods/design In this randomized controlled trial, 308 participants (born in Iraq, living in Malmö, Sweden and at high risk of type 2 diabetes) will be allocated to either a culturally adapted intervention or a control group. The intervention will consist of 10 group counseling sessions focusing on diet, physical activity and behavioral change over 6 months, and the offer of exercise sessions. Cultural adaptation includes gender-specific exercise sessions, and counseling by a health coach community member. The control group will receive the information about healthy lifestyle habits provided by the primary health care center. The primary outcome is change in fasting glucose level. Secondary outcomes are changes in body mass index, insulin sensitivity, physical activity, food habits and health-related quality of life. Measurements will be taken at baseline, after 3 and 6 months. Data will be analyzed by the intention-to-treat approach. The cost-effectiveness during the trial period and over the longer term will be assessed by simulation modeling from patient, health care and societal perspectives. Discussion This study will provide a basis to measure the effectiveness of a lifestyle intervention designed for immigrants from the Middle East in terms of improvement in glucose metabolism, and will also assess its cost-effectiveness. Results from this trial may help health care providers and policy makers to adapt and implement lifestyle interventions suitable for this population group that can be

  4. The DAILY (Daily Automated Intensive Log for Youth) trial: a wireless, portable system to improve adherence and glycemic control in youth with diabetes.

    PubMed

    Kumar, Vikram S; Wentzell, Katherine J; Mikkelsen, Tarjei; Pentland, Alex; Laffel, Lori M

    2004-08-01

    Blood glucose (BG) monitoring (BGM) is an important component of diabetes management. New wireless technologies may facilitate BGM and help to optimize glycemic control. We evaluated an integrated wireless approach with and without a motivational game in youth with diabetes. Forty youth, 8-18 years old, each received a handheld device fitted with a wireless modem and diabetes data management software, plus a wireless-enabled BG monitor. Half were randomized to receive the new technologies along with an integrated motivational game in which the participants would guess a BG level following collection of three earlier readings (Game Group). BG data, insulin doses, and carbohydrate intake were displayed graphically prior to the glucose estimation. The other group received the new technologies alone (Control Group). Both groups were instructed to perform BGM four times daily and transmit their data to a central server via the wireless modem. Feasibility of implementation and outcomes were ascertained after 4 weeks. Ninety-three percent of participants successfully transmitted their data wirelessly to the server. The Game Group transmitted significantly more glucose values than the Control Group (P < 0.001). The Game Group also had significantly less hyperglycemia (glucose >/=13.9 mmol/L or >/=250 mg/dL) than the Control Group (P < 0.001). Youth in the Game Group displayed a significant increase in diabetes knowledge over the 4-week trial (P < 0.005). Finally, there was a trend for more youth in the Game Group to maintain hemoglobin A1C values diabetes can successfully implement new technologies to facilitate BGM. Use of a motivational game appears to increase the frequency of monitoring, reduce the frequency of hyperglycemia, and improve diabetes knowledge, and may help to optimize glycemic control. PMID:15320998

  5. Does early intensive multifactorial therapy reduce modelled cardiovascular risk in individuals with screen-detected diabetes? Results from the ADDITION-Europe cluster randomized trial

    PubMed Central

    Black, J A; Sharp, S J; Wareham, N J; Sandbæk, A; Rutten, G E H M; Lauritzen, T; Khunti, K; Davies, M J; Borch-Johnsen, K; Griffin, S J; Simmons, R K

    2014-01-01

    Aims Little is known about the long-term effects of intensive multifactorial treatment early in the diabetes disease trajectory. In the absence of long-term data on hard outcomes, we described change in 10-year modelled cardiovascular risk in the 5 years following diagnosis, and quantified the impact of intensive treatment on 10-year modelled cardiovascular risk at 5 years. Methods In a pragmatic, cluster-randomized, parallel-group trial in Denmark, the Netherlands and the UK, 3057 people with screen-detected Type 2 diabetes were randomized by general practice to receive (1) routine care of diabetes according to national guidelines (1379 patients) or (2) intensive multifactorial target-driven management (1678 patients). Ten-year modelled cardiovascular disease risk was calculated at baseline and 5 years using the UK Prospective Diabetes Study Risk Engine (version 3β). Results Among 2101 individuals with complete data at follow up (73.4%), 10-year modelled cardiovascular disease risk was 27.3% (sd 13.9) at baseline and 21.3% (sd 13.8) at 5-year follow-up (intensive treatment group difference –6.9, sd 9.0; routine care group difference –5.0, sd 12.2). Modelled 10-year cardiovascular disease risk was lower in the intensive treatment group compared with the routine care group at 5 years, after adjustment for baseline cardiovascular disease risk and clustering (–2.0; 95% CI –3.1 to –0.9). Conclusions Despite increasing age and diabetes duration, there was a decline in modelled cardiovascular disease risk in the 5 years following diagnosis. Compared with routine care, 10-year modelled cardiovascular disease risk was lower in the intensive treatment group at 5 years. Our results suggest that patients benefit from intensive treatment early in the diabetes disease trajectory, where the rate of cardiovascular disease risk progression may be slowed. PMID:24533664

  6. Mobile reminders to improve opportunistic screening of type 2 diabetes mellitus: Data documentation and data analysis plan of a randomized trial data.

    PubMed

    Shewade, Hemant Deepak; Kumar, Sathish

    2016-03-01

    This Data in Brief article contains individual level data of a randomized trial in a primary care setting. This trial offered mobile reminder to follow up for definitive tests during opportunistic screening of diabetes mellitus in Puducherry, India (2014). ("Effect of mobile reminders on screening yield during opportunistic screening for type 2 diabetes mellitus in a primary health care setting: a randomized trial" (Kumar et al., 2015) [1]) Variables collected included the baseline characteristics of study participants (n=390) and information on initial screening and eligibility for definitive test, study group (intervention/control), follow up for definitive test and definitive test results. The data was double entered with adequate checks and validated in EpiData. Final data after correcting the data entry errors has been shared here. In addition, we have shared data entry plan, EpiData triplet files for data entry and program file for data analysis. They may be used by other researchers who intend to replicate this research in their setting. PMID:26937453

  7. Peer Support Training Improved the Glycemic Control, Insulin Management, and Diabetic Behaviors of Patients with Type 2 Diabetes in Rural Communities of Central China: A Randomized Controlled Trial

    PubMed Central

    Deng, Kaiqin; Ren, Yanlei; Luo, Zhongmei; Du, Kun; Zhang, Xiaoqin; Zhang, Qiong

    2016-01-01

    Background The efficacy of peer support in Chinese diabetes patients is still uncertain. The purpose of this study was to observe the effects of a peer support program on the outcomes of patients with type 2 diabetes who received community-based insulin therapy in rural communities of central China. Material/Methods Two hundred and eight eligible patients with type 2 diabetes were randomly assigned into the traditional training group (control group, n=111) and peer support intervention group (peer group, n=97) between June 2013 and January 2014 in 2 rural communities of Jingzhou area, China. Both groups received 3-month traditional training, followed by another 4-month traditional training or peer support training, respectively. At baseline and 7 months after treatment, the blood glycemic level was evaluated by biochemical detection. Capacities of self-management and knowledge related to insulin usage were assessed by questionnaire survey. Results Ninety-seven and ninety patients completed this study in the control group and peer group, respectively. There was no significant difference in age, gender, diabetes duration, insulin usage time, and complications between the 2 groups at baseline (P>0.05). Compared with the control group, peer group patients achieved a more significant decrease in blood glycosylated hemoglobin levels (P<0.05), increase in knowledge related to insulin usage, and increase of diabetes self-management ability (P<0.05). Conclusions Peer support intervention effectively improves outcomes of patients with type 2 diabetes in rural communities of central China. PMID:26808489

  8. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme.

    PubMed

    Yu, M; Van Brunt, K; Varnado, O J; Boye, K S

    2016-04-01

    We evaluated patient-reported outcome (PRO) measures from the Assessment of Weekly AdministRation of LY2189265 (dulaglutide) in Diabetes (AWARD) clinical trial programme for dulaglutide (1.5 mg and 0.75 mg) in patients with type 2 diabetes (T2D). The Impact of Weight on Self-Perception (IW-SP), Impact of Weight on Ability to Perform Physical Activities of Daily Living (APPADL), Impact of Weight on Quality of Life-Lite, EQ-5D, Diabetes Treatment Satisfaction Questionnaire (DTSQ), Diabetes Symptom Checklist-Revised and Adult Low Blood Sugar Survey were administered and analysed for changes from baseline in one or more AWARD studies. Significant within-group changes from baseline to the primary time point were observed for several PRO measures across all studies. Compared with insulin glargine, significantly greater improvements in the IW-SP score were observed with dulaglutide 1.5 mg and with both dulaglutide doses in the APPADL score. Both dulaglutide doses resulted in significantly greater improvement in DTSQ scores (all subscales) compared with exenatide. Dulaglutide 1.5 mg also resulted in significantly greater improvement on the DTSQ hyperglycaemia subscale compared with metformin. Overall, these PRO results suggest that dulaglutide is beneficial in the treatment of T2D. PMID:26691396

  9. The Mexican-American Trial of Community Health workers (MATCH): Design and baseline characteristics of a randomized controlled trial testing a culturally tailored community diabetes self-management intervention

    PubMed Central

    Rothschild, Steven K.; Martin, Molly A.; Swider, Susan M.; Lynas, Carmen T.; Avery, Elizabeth F.; Janssen, Imke; Powell, Lynda H.

    2012-01-01

    Objectives Community Health Workers (CHWs) have been recommended to reduce diabetes disparities, but few robust trials of this approach have been conducted. Limitations of prior studies include: unspecified a priori outcomes; lack of blinded outcome assessments; high participant attrition rates; and lack of attention to intervention fidelity. These limitations reflect challenges in balancing methodologic rigor with the needs of vulnerable populations. The Mexican-American Trial of Community Health workers (MATCH) was a blinded randomized controlled trial testing CHW efficacy in improving physiologic outcomes and self-management behaviors among Mexican-Americans with type 2 diabetes. This paper describes methods used to overcome limitations of prior studies. Research Design and Methods The primary aim was to determine if a CHW intervention would result in significant reductions in Hemoglobin A1c and rates of uncontrolled blood pressure. 144 Mexican-Americans with diabetes were randomized. The intervention consisted of self-management training delivered by CHWs over a 24-month period; the comparison population received identical information via bilingual newsletter. Blinded research assistants completed assessments at baseline, 12 months, and 24 months post-randomization. Results The MATCH cohort was characterized by low acculturation and socioeconomic status. Study participants had low rates of medication adherence and glucose monitoring. 70% had poor glycemic control with A1c levels over 7.0, and 57.3% had blood pressures worse than ADA target levels (<130/80). Conclusions MATCH preserved community sensitivity and methodologic rigor. The study’s attention to intervention fidelity, behavioral attention control, blinded outcomes assessment, and strategies to enhance participant retention can be replicated by researchers testing culturally-tailored CHW interventions. PMID:22115970

  10. Protocol for SAMS (Support and Advice for Medication Study): A randomised controlled trial of an intervention to support patients with type 2 diabetes with adherence to medication

    PubMed Central

    Farmer, Andrew J; Prevost, A Toby; Hardeman, Wendy; Craven, Anthea; Sutton, Stephen; Griffin, Simon J; Kinmonth, Ann-Louise

    2008-01-01

    Background Although some interventions have been shown to improve adherence to medication for diabetes, results are not consistent. We have developed a theory-based intervention which we will evaluate in a well characterised population to test efficacy and guide future intervention development and trial design. Methods and Design The SAMS (Supported Adherence to Medication Study) trial is a primary care based multi-centre randomised controlled trial among 200 patients with type 2 diabetes and an HbA1c of 7.5% or above. It is designed to evaluate the efficacy of a two-component motivational intervention based on the Theory of Planned Behaviour and volitional action planning to support medication adherence compared with standard care. The intervention is delivered by practice nurses. Nurses were trained using a workshop approach with role play and supervised using assessment of tape-recorded consultations. The trial has a two parallel groups design with an unbalanced three-to-two individual randomisation eight weeks after recruitment with twelve week follow-up. The primary outcome is medication adherence measured using an electronic medication monitor over 12 weeks and expressed as the difference between intervention and control in mean percentage of days on which the correct number of medication doses is taken. Subgroup analyses will explore impact of number of medications taken, age, HbA1c, and self-reported adherence at baseline on outcomes. The study also measures the effect of dispensing medication to trial participants packaged in the electronic medication-monitoring device compared with conventional medication packaging. This will be achieved through one-to-one randomisation at recruitment to these conditions with assessment of the difference between groups in self-report of medication adherence and change in mean HbA1c from baseline to eight weeks. Anonymised demographic data are collected on non-respondents. Central randomisation is carried out independently

  11. Clopidogrel: A multifaceted affair.

    PubMed

    Martínez-Quintana, Efrén; Tugores, Antonio

    2015-01-01

    Clopidogrel has been the therapy of choice, combined with aspirin, against platelet aggregation in patients at risk of suffering a vascular thrombotic event. Not all patients respond equally to clopidogrel, an observation that has led to searching for a test that, in the clinical setting, could predict patients' "resistance" to therapy. The evidence reveals a complex pharmacokinetic profile for clopidogrel, with multiple players involved, including cytochromes, characteristics of the target tissue, and accompanying clinical conditions. Despite FDA black box warnings recommending CYP2C19 genotyping before clopidogrel use, no robust evidence indicates that CYP2C19 function determines clinical response to the drug, either based on the presence of loss of function alleles or drug interactions with CYP2C19 inhibitors, like omeprazole. A tailored anti-aggregation treatment based on ex vivo platelet reactivity also seems unlikely due to the lack of robustness of most assays. The identification of clinical conditions that are at higher risk of new cardiovascular events, such as diabetes, obesity, coronary artery disease, or specific stenting procedures, seems to be a prudent approach to tailor anti-platelet therapy with more powerful drugs, accompanied by careful counseling to promote patient compliance. PMID:25328019

  12. Design of a Cluster-Randomized Controlled Trial of a Diabetes Prevention Program within African-American Churches: The Fit Body and Soul Study

    PubMed Central

    Williams, Lovoria B.; Sattin, Richard W.; Dias, James; Garvin, Jane T.; Marion, Lucy; Joshua, Thomas; Kriska, Andrea; Kramer, M. Kaye; Echouffo-Tcheugui, Justin B.; Freeman, Arin; Narayan, K.M. Venkat

    2013-01-01

    Evidence from varied community settings has shown that the Group Lifestyle Balance (GLB) Program and other adaptations of the Diabetes Prevention Program (DPP) intervention are effective in lowering diabetes risk. Most DPP data originated from studies of pre-diabetic whites, with only sparse evidence of the effect of DPP in African Americans (AAs) in community settings. This paper describes the design, methods, baseline characteristics and cost effective measures, of a single-blinded, cluster- randomized trial of a faith-based adaptation of the GLB program, Fit Body and Soul (FBAS). The major aims are to test efficacy and cost utility of FBAS in twenty AA churches. Randomization occurred at the church level and 604 AA overweight/obese (BMI≥25 kg/m2) adults with fasting plasma glucose range from normal to pre-diabetic received either FBAS or a health-education comparison program. FBAS is a group-based, multi-level intervention delivered by trained church health advisors (health professionals from within the church), with the goal of ≥7% weight loss, achieved through increasing physical activity, healthy eating and behavior modification. The primary outcome is weight change at 12-weeks post intervention. Secondary outcomes include hemoglobin A1C, fasting plasma glucose, waist circumference, blood pressure, physical activity level, quality of life measures, and cost-effectiveness. FBAS is the largest known cohort of AAs enrolled in a faith-based DPP translation. Reliance on health professionals from within the church for program implementation and the cost analysis are unique aspects of this trial. The design provides a model for faith-based DPPs and holds promise for program sustainability and widespread dissemination. PMID:23354313

  13. Effects of stress reduction on cardiovascular risk factors in type 2 diabetes patients with early kidney disease - results of a randomized controlled trial (HEIDIS).

    PubMed

    Kopf, S; Oikonomou, D; Hartmann, M; Feier, F; Faude-Lang, V; Morcos, M; Häring, H-U; Herzog, W; Bierhaus, A; Humpert, P M; Nawroth, P P

    2014-06-01

    Current guidelines for the treatment of type 2 diabetes focus on pharmacological treatment of glucose and cardio-vascular risk factors. The aim of this prospective randomized controlled intervention study was to examine the effects of a psychosocial intervention on clinical endpoints and risk factors in patients with type 2 diabetes and early diabetic kidney disease.110 patients were randomized to receive an 8-week mindfulness-based stress reduction (MBSR) training (n = 53) compared to standard care (n = 57). The study was carried out open-labelled and randomization was performed computer-generated in a 1:1 ratio. Primary outcome of the study was the change in urinary albumin excretion (albumin-creatinine-ratio, ACR); secondary outcomes were metabolic parameters, intima media thickness (IMT), psychosocial parameters and cardiovascular events.89 patients (42 in control group and 47 in intervention group) were analysed after 3 years of follow-up. After 1 year, the intervention group showed a reduction of ACR from 44 [16/80] to 39 [20/71] mg/g, while controls increased from 47 [16/120] to 59 [19/128] mg/g (p = 0.05). Parallel to the reduction of stress levels after 1 year, the intervention-group additionally showed reduced catecholamine levels (p < 0.05), improved 24 h-mean arterial (p < 0.05) and maximum systolic blood pressure (p < 0.01), as well as a reduction in IMT (p < 0.01). However, these effects were lost after 2 and 3 years of follow-up.This is the first study to show that a psychosocial intervention improves cardiovascular risk factors in high risk type 2 diabetes patients. Trial-Registration: NCT00263419 http://clinicaltrials.gov/ct2/show/NCT00263419 TRIAL REGISTRATION: clinicaltrials.gov-Identifier: NCT00263419. PMID:24798861

  14. Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial

    PubMed Central

    2012-01-01

    Background The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza. Methods/design This is a prospective phase IV cluster clinical trial conducted under routine conditions in 14 primary health care centres of Osakidetza, randomly assigned to an intervention or control group. We will recruit a total sample of 1089 individuals, aged between 45 and 70 years old, without diabetes but at high risk of developing the condition (Finnish Diabetes Risk Score, FINDRISC ≥ 14) and follow them up for 2 years. Primary health care nursing teams of the intervention centres will implement DE-PLAN, a structured educational intervention program focused on changing healthy lifestyles (diet and physical activity); while the patients in the control centres will receive the usual care for the prevention and treatment of DM2 currently provided in Osakidetza. The effectiveness attributable to the programme will be assessed by comparing the changes observed in patients exposed to the intervention and those in the control group, with respect to the risk of developing DM2 and lifestyle habits. In terms of feasibility, we will assess indicators of population coverage and programme implementation. Discussion The aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2. The study design will enable us to gather information on the effectiveness of the intervention as well as the feasibility of implementing it in routine practice. Trial registration ClinicalTrials.gov NCT01365013 PMID:23158830

  15. Midcourse correction to a clinical trial when the event rate is underestimated: the Look AHEAD (Action for Health in Diabetes) Study.

    PubMed

    Brancati, Frederick L; Evans, Mary; Furberg, Curt D; Geller, Nancy; Haffner, Steven; Kahn, Steven E; Kaufmann, Peter G; Lewis, Cora E; Nathan, David M; Pitt, Bertram; Safford, Monika M

    2012-02-01

    The Look AHEAD (Action for Health in Diabetes) Study is a long-term clinical trial that aims to determine the cardiovascular disease (CVD) benefits of an intensive lifestyle intervention (ILI) in obese adults with type 2 diabetes. The study was designed to have 90% statistical power to detect an 18% reduction in the CVD event rate in the ILI Group compared to the Diabetes Support and Education (DSE) Group over 10.5 years of follow-up. The original power calculations were based on an expected CVD rate of 3.125% per year in the DSE group; however, a much lower-than-expected rate in the first 2 years of follow-up prompted the Data and Safety Monitoring Board (DSMB) to recommend that the Steering Committee undertake a formal blinded evaluation of these design considerations. The Steering Committee created an Endpoint Working Group (EPWG) that consisted of individuals masked to study data to examine relevant issues. The EPWG considered two primary options: (1) expanding the definition of the primary endpoint and (2) extending follow-up of participants. Ultimately, the EPWG recommended that the Look AHEAD Steering Committee approve both strategies. The DSMB accepted these modifications, rather than recommending that the trial continue with inadequate statistical power. Trialists sometimes need to modify endpoints after launch. This decision should be well justified and should be made by individuals who are fully masked to interim results that could introduce bias. This article describes this process in the Look AHEAD study and places it in the context of recent articles on endpoint modification and recent trials that reported endpoint modification. PMID:22334468

  16. Anti-diabetic and antioxidant effect of cinnamon in poorly controlled type-2 diabetic Iraqi patients: A randomized, placebo-controlled clinical trial

    PubMed Central

    Sahib, Ahmed Salih

    2016-01-01

    Aim: To determine the effect of cinnamon on fasting blood glucose, hemoglobin (Hb) A1c, and oxidative stress markers in poorly controlled type 2 diabetes. Patients and Methods: A total of 25 type 2 diabetic patients of both sexes, aged 49.1 ± 6.0, treated only with hypoglycemic agent sulfonylurea (glibenclamide) were randomly assigned to receive either 1 g of cinnamon or placebo daily for 12 weeks. Results: A highly significant (P ≤ 0.001) reduction (10.12%) of fasting blood glucose level after 6 and 12 weeks of treatment 10.12% and 17.4%, respectively, compared to baseline value and to placebo group at corresponding duration. Meanwhile, the value of glycosylated Hb reduced in cinnamon treated group by (2.625%) and (8.25%) after 6 and 12 weeks, respectively, although this reduction was non-significant compared to baseline value. Concerning the oxidative stress markers, the level of serum glutathione showed highly significant (P ≤ 0.001) elevation after 12 weeks as compared to baseline value and placebo group at corresponding duration, malondialdehyde serum level decreased after treatment of diabetic patients with cinnamon resulted in highly significant (P ≤ 0.001) reduction after 6 and 12 weeks compared to placebo group, but when compared to baseline value, there is a (15%) reduction only after 12 weeks of treatment which was considered highly significant (P ≤ 0.001) change, Finally, administration of cinnamon to diabetic patients for 12 weeks resulted in significant (P ≤ 0.05) elevation of superoxide dismutase level. Conclusion: Intake of 1 g of cinnamon for 12 weeks reduces fasting blood glucose and glycosylated Hb among poorly controlled type 2 diabetes patients, as well as, there is improvement in the oxidative stress markers, indicating the beneficial effect of adjuvant cinnamon as anti-diabetic and antioxidant along with conventional medications to treat poorly controlled type 2 diabetes mellitus. PMID:27104030

  17. A Mobile Telehealth Intervention for Adults With Insulin-Requiring Diabetes: Early Results of a Mixed-Methods Randomized Controlled Trial

    PubMed Central

    Baron, Justine; Hirani, Shashivadan

    2015-01-01

    Background The role of technology in health care delivery has grown rapidly in the last decade. The potential of mobile telehealth (MTH) to support patient self-management is a key area of research. Providing patients with technological tools that allow for the recording and transmission of health parameters to health care professionals (HCPs) may promote behavior changes that result in improved health outcomes. Although for some conditions the evidence of the effectiveness of MTH is clear, to date the findings on the effects of MTH on diabetes management remain inconsistent. Objective This study aims to evaluate an MTH intervention among insulin-requiring adults with diabetes to establish whether supplementing standard care with MTH results in improved health outcomes—glycated hemoglobin (HbA1c), blood pressure (BP), health-related quality of life (HRQoL), diabetes self-management behaviors, diabetes health care utilization, and diabetes self-efficacy and illness beliefs. An additional objective was to explore the acceptability of MTH and patients’ perceptions of, and experience, using it. Methods A mixed-method design consisting of a 9-month, two-arm, parallel randomized controlled trial (RCT) was used in combination with exit qualitative interviews. Quantitative data was collected at baseline, 3 months, and 9 months. Additional intervention fidelity data, such as participants’ MTH transmissions and contacts with the MTH nurse during the study, were also recorded. Results Data collection for both the quantitative and qualitative components of this study has ended and data analysis is ongoing. A total of 86 participants were enrolled into the study. Out of 86 participants, 45 (52%) were randomized to the intervention group and 36 (42%) to the control group. Preliminary data on MTH training sessions and MTH usage by intervention participants are presented in this paper. We expect to publish complete study results in 2015. Conclusions The range of data

  18. Diabetes mellitus as a compelling indication for use of renin angiotensin system blockers: systematic review and meta-analysis of randomized trials

    PubMed Central

    Fakheri, Robert; Toklu, Bora; Messerli, Franz H

    2016-01-01

    Objective To evaluate the outcomes with use of renin angiotensin system (RAS) blockers compared with other antihypertensive agents in people with diabetes. Design Meta-analysis. Data sources and study selection PubMed, Embase, and the Cochrane central register of controlled trials databases for randomized trials of RAS blockers versus other antihypertensive agents in people with diabetes mellitus. Outcomes were death, cardiovascular death, myocardial infarction, angina, stroke, heart failure, revascularization, and end stage renal disease. Results The search yielded 19 randomized controlled trials that enrolled 25 414 participants with diabetes for a total of 95 910 patient years of follow-up. When compared with other antihypertensive agents, RAS blockers were associated with a similar risk of death (relative risk 0.99, 95% confidence interval 0.93 to 1.05), cardiovascular death (1.02, 0.83 to 1.24), myocardial infarction (0.87, 0.64 to 1.18), angina pectoris (0.80, 0.58 to 1.11), stroke (1.04, 0.92 to 1.17), heart failure (0.90, 0.76 to 1.07), and revascularization (0.97, 0.77 to 1.22). There was also no difference in the hard renal outcome of end stage renal disease (0.99, 0.78 to 1.28) (power of 94% to show a 23% reduction in end stage renal disease). Conclusions In people with diabetes, RAS blockers are not superior to other antihypertensive drug classes such as thiazides, calcium channel blockers, and β blockers at reducing the risk of hard cardiovascular and renal endpoints. These findings support the recommendations of the guidelines of the European Society of Cardiology/European Society of Hypertension and eighth Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure to also use other antihypertensive agents in people with diabetes but without kidney disease. PMID:26868137

  19. Living Well with Diabetes: a randomized controlled trial of a telephone-delivered intervention for maintenance of weight loss, physical activity and glycaemic control in adults with type 2 diabetes

    PubMed Central

    2010-01-01

    Background By 2025, it is estimated that approximately 1.8 million Australian adults (approximately 8.4% of the adult population) will have diabetes, with the majority having type 2 diabetes. Weight management via improved physical activity and diet is the cornerstone of type 2 diabetes management. However, the majority of weight loss trials in diabetes have evaluated short-term, intensive clinic-based interventions that, while producing short-term outcomes, have failed to address issues of maintenance and broad population reach. Telephone-delivered interventions have the potential to address these gaps. Methods/Design Using a two-arm randomised controlled design, this study will evaluate an 18-month, telephone-delivered, behavioural weight loss intervention focussing on physical activity, diet and behavioural therapy, versus usual care, with follow-up at 24 months. Three-hundred adult participants, aged 20-75 years, with type 2 diabetes, will be recruited from 10 general practices via electronic medical records search. The Social-Cognitive Theory driven intervention involves a six-month intensive phase (4 weekly calls and 11 fortnightly calls) and a 12-month maintenance phase (one call per month). Primary outcomes, assessed at 6, 18 and 24 months, are: weight loss, physical activity, and glycaemic control (HbA1c), with weight loss and physical activity also measured at 12 months. Incremental cost-effectiveness will also be examined. Study recruitment began in February 2009, with final data collection expected by February 2013. Discussion This is the first study to evaluate the telephone as the primary method of delivering a behavioural weight loss intervention in type 2 diabetes. The evaluation of maintenance outcomes (6 months following the end of intervention), the use of accelerometers to objectively measure physical activity, and the inclusion of a cost-effectiveness analysis will advance the science of broad reach approaches to weight control and health

  20. Cost effectiveness of self monitoring of blood glucose in patients with non-insulin treated type 2 diabetes: economic evaluation of data from the DiGEM trial

    PubMed Central

    2008-01-01

    Objective To assess the cost effectiveness of self monitoring of blood glucose alone or with additional training in incorporating the results into self care, in addition to standardised usual care for patients with non-insulin treated type 2 diabetes. Design Incremental cost utility analysis from a healthcare perspective. Data on resource use from the randomised controlled diabetes glycaemic education and monitoring (DiGEM) trial covered 12 months before baseline and 12 months of trial follow-up. Quality of life was measured at baseline and 12 months using the EuroQol EQ-5D questionnaire. Setting Primary care in the United Kingdom. Participants 453 patients with non-insulin treated type 2 diabetes. Interventions Standardised usual care (control) compared with additional self monitoring of blood glucose alone (less intensive self monitoring) or with training in self interpretation of the results (more intensive self monitoring). Main outcome measures Quality adjusted life years and healthcare costs (sterling in 2005-6 prices). Results The average costs of intervention were £89 (€113; $179) for standardised usual care, £181 for less intensive self monitoring, and £173 for more intensive self monitoring, showing an additional cost per patient of £92 (95% confidence interval £80 to £103) in the less intensive group and £84 (£73 to £96) in the more intensive group. No other significant cost difference was detected between the groups. An initial negative impact of self monitoring on quality of life occurred, averaging −0.027 (95% confidence interval−0.069 to 0.015) for the less intensive self monitoring group and −0.075 (−0.119 to −0.031) for the more intensive group. Conclusions Self monitoring of blood glucose with or without additional training in incorporating the results into self care was associated with higher costs and lower quality of life in patients with non-insulin treated type 2 diabetes. In light of this, and no clinically significant

  1. The effects of n-3 long-chain polyunsaturated fatty acid supplementation on biomarkers of kidney injury in adults with diabetes: results of the GO-FISH trial.

    PubMed

    Miller, Edgar R; Juraschek, Stephen P; Anderson, Cheryl A; Guallar, Eliseo; Henoch-Ryugo, Karen; Charleston, Jeanne; Turban, Sharon; Bennett, Michael R; Appel, Lawrence J

    2013-06-01

    OBJECTIVE Long-chain n-3 polyunsaturated fatty acid (n-3 PUFA) supplements may have renoprotective effects in patients with diabetes, but previous trials have been inconsistent. We performed a randomized controlled trial of n-3 PUFA supplementation on urine albumin excretion and markers of kidney injury in adults with type 2 diabetes. RESEARCH DESIGN AND METHODS We conducted a randomized, placebo-controlled, two-period crossover trial to test the effects of 4 g/day of n-3 PUFA supplementation on markers of glomerular filtration and kidney injury in adults with adult-onset diabetes and greater than or equal to trace amounts of proteinuria. Each period lasted 6 weeks and was separated by a 2-week washout. The main outcome was urine albumin excretion and, secondarily, markers of kidney injury (kidney injury molecule-1, N-acetyl β-d-glucosaminidase [NAG], neutrophil gelatinase-associated lipocalin [NGAL], and liver fatty acid-binding protein [LFABP]), serum markers of kidney function (cystatin C, β2-microglobulin, and creatinine), and estimated glomerular filtration rate (eGFR). RESULTS Of the 31 participants, 29 finished both periods. A total of 55% were male, and 61% were African American; mean age was 67 years. At baseline, mean BMI was 31.6 kg/m(2), median eGFR was 76.9 mL/min/1.73 m(2), and median 24-h urine albumin excretion was 161 mg/day. Compared with placebo, n-3 PUFA had nonsignificant effects on urine albumin excretion (-7.2%; 95% CI -20.6 to 8.5; P = 0.35) and significant effects on urine NGAL excretion (-16% [-29.1 to -0.5%]; P = 0.04). There was no effect on serum markers of kidney function or eGFR. In subgroup analyses, there were significant decreases in 24-h urinary excretion of albumin, NGAL, LFABP, and NAG among participants taking medications that block the renin-angiotensin-aldosterone system (RAAS). CONCLUSIONS These results suggest a potential effect of n-3 PUFA supplementation on markers of kidney injury in patients with diabetes and early

  2. The use of green tea polyphenols for treating residual albuminuria in diabetic nephropathy: A double-blind randomised clinical trial

    PubMed Central

    Borges, Cynthia M.; Papadimitriou, Alexandros; Duarte, Diego A.; Lopes de Faria, Jacqueline M.; Lopes de Faria, José B.

    2016-01-01

    Prior research has shown that in experimental diabetes mellitus, green tea reduces albuminuria by decreasing podocyte apoptosis through activation of the WNT pathway. We investigated the effect of green tea polyphenols (GTP) on residual albuminuria of diabetic subjects with nephropathy. We conducted a randomised, double-blind study in 42 diabetic subjects with a urinary albumin-creatinine ratio (UACR) >30 mg/g, despite administration of the maximum recommended dose of renin-angiotensin (RAS) inhibition. Patients were randomly assigned to two equal groups to receive either GTP (containing 800 mg of epigallocatechin gallate, 17 with type 2 diabetes and 4 with type 1 diabetes) or placebo (21 with type 2 diabetes) for 12 weeks. Treatment with GTP reduced UACR by 41%, while the placebo group saw a 2% increase in UACR (p = 0.019). Podocyte apoptosis (p = 0.001) and in vitro albumin permeability (p < 0.001) were higher in immortalized human podocytes exposed to plasma from diabetic subjects compared to podocytes treated with plasma from normal individuals. In conclusion, GTP administration reduces albuminuria in diabetic patients receiving the maximum recommended dose of RAS. Reduction in podocyte apoptosis by activation of the WNT pathway may have contributed to this effect. PMID:27320846

  3. Multisystemic Therapy for Adolescents with Poorly Controlled Type I Diabetes: Stability of Treatment Effects in a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Ellis, Deborah A.; Templin, Thomas; Naar-King, Sylvie; Frey, Maureen A.; Cunningham, Phillippe B.; Podolski, Cheryl-Lynn; Cakan, Nedim

    2007-01-01

    The primary purpose of the present study was to determine whether multisystemic therapy (MST), an intensive, home-based psychotherapy, improved regimen adherence, metabolic control, and rates of hospitalization for diabetic ketoacidosis (DKA) among adolescents with chronically poorly controlled Type 1 diabetes 6 months after the completion of…

  4. The use of green tea polyphenols for treating residual albuminuria in diabetic nephropathy: A double-blind randomised clinical trial.

    PubMed

    Borges, Cynthia M; Papadimitriou, Alexandros; Duarte, Diego A; Lopes de Faria, Jacqueline M; Lopes de Faria, José B

    2016-01-01

    Prior research has shown that in experimental diabetes mellitus, green tea reduces albuminuria by decreasing podocyte apoptosis through activation of the WNT pathway. We investigated the effect of green tea polyphenols (GTP) on residual albuminuria of diabetic subjects with nephropathy. We conducted a randomised, double-blind study in 42 diabetic subjects with a urinary albumin-creatinine ratio (UACR) >30 mg/g, despite administration of the maximum recommended dose of renin-angiotensin (RAS) inhibition. Patients were randomly assigned to two equal groups to receive either GTP (containing 800 mg of epigallocatechin gallate, 17 with type 2 diabetes and 4 with type 1 diabetes) or placebo (21 with type 2 diabetes) for 12 weeks. Treatment with GTP reduced UACR by 41%, while the placebo group saw a 2% increase in UACR (p = 0.019). Podocyte apoptosis (p = 0.001) and in vitro albumin permeability (p < 0.001) were higher in immortalized human podocytes exposed to plasma from diabetic subjects compared to podocytes treated with plasma from normal individuals. In conclusion, GTP administration reduces albuminuria in diabetic patients receiving the maximum recommended dose of RAS. Reduction in podocyte apoptosis by activation of the WNT pathway may have contributed to this effect. PMID:27320846

  5. Weight loss and fitness improvement in persons with type 2 diabetes: Experiences for the Look AHEAD trial intervention

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The methods used and outcomes observed in the Look AHEAD trial are of great interest to weight management practitioners. The practices from this clinical trial can be directly applied to clinical practice efforts. This paper reports the 1- and 4-year findings of the Look AHEAD trial for use by weigh...

  6. Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island

    PubMed Central

    2012-01-01

    Background Self-management education programs can reduce the complications and mortality in type 2 diabetes. The need to structure these programs for outpatient and community care with a vision for long-term maintenance has been recognised. In Reunion Island, an area affected by epidemiological and nutritional transition, diabetes affects 18% of the adult population over 30 years, with major social disparities, poor glycaemic control and frequent cardiovascular complications. Methods/Design ERMIES is a randomised controlled trial designed to test the efficacy of a long-term (2 years) structured group self management educational intervention in improving blood glucose in non-recent, insufficiently controlled diabetes. After an initial structured educational cycle carried out blind for the intervention arm, patients will be randomised in two parallel group arms of 120 subjects: structured on-going group with educational intervention maintained over two years, versus only initial education. Education sessions are organised through a regional diabetes management network, and performed by trained registered nurses at close quarters. The educational approach is theoretically based (socio-constructivism, social contextualisation, empowerment, action planning) and reproducible, thanks to curricula and handouts for educators and learners. The subjects will be recruited from five hospital outpatient settings all over Reunion Island. The main eligibility criteria include: age ≥18 years, type 2 diabetes treated for more than one year, HbA1c ≥ 7.5% for ≥3 months, without any severe evolving complication (ischaemic or proliferative retinopathy, severe renal insufficiency, coronaropathy or evolving foot lesion), and absence of any major physical or cognitive handicap. The primary outcome measure is HbA1c evolution between inclusion and 2 years. The secondary outcome measures include anthropometric indicators, blood pressure, lipids, antidiabetic medications, level of

  7. An evidence-based shared decision making programme on the prevention of myocardial infarction in type 2 diabetes: protocol of a randomised-controlled trial

    PubMed Central

    2013-01-01

    Background Lack of patient involvement in decision making has been suggested as one reason for limited treatment success. Concepts such as shared decision making may contribute to high quality healthcare by supporting patients to make informed decisions together with their physicians. A multi-component shared decision making programme on the prevention of heart attack in type 2 diabetes has been developed. It aims at improving the quality of decision-making by providing evidence-based patient information, enhancing patients’ knowledge, and supporting them to actively participate in decision-making. In this study the efficacy of the programme is evaluated in the setting of a diabetes clinic. Methods/Design A single blinded randomised-controlled trial is conducted to compare the shared decision making programme with a control-intervention. The intervention consists of an evidence-based patient decision aid on the prevention of myocardial infarction and a corresponding counselling module provided by diabetes educators. Similar in duration and structure, the control-intervention targets nutrition, sports, and stress coping. A total of 154 patients between 40 and 69 years of age with type 2 diabetes and no previous diagnosis of ischaemic heart disease or stroke are enrolled and allocated either to the intervention or the control-intervention. Primary outcome measure is the patients’ knowledge on benefits and harms of heart attack prevention captured by a standardised knowledge test. Key secondary outcome measure is the achievement of treatment goals prioritised by the individual patient. Treatment goals refer to statin taking, HbA1c-, blood pressure levels and smoking status. Outcomes are assessed directly after the counselling and at 6 months follow-up. Analyses will be carried out on intention-to-treat basis. Concurrent qualitative methods are used to explore intervention fidelity and to gain insight into implementation processes. Discussion Interventions to

  8. Effect of a Long-Term Behavioral Weight Loss Intervention on Nephropathy in Overweight or Obese Adults with Type 2 Diabetes: the Look AHEAD Randomized Clinical Trial

    PubMed Central

    Knowler, William C.; Bahnson, Judy L.; Bantle, John P.; Bertoni, Alain G.; Bray, George A.; Chen, Haiying; Cheskin, Lawrence; Clark, Jeanne M.; Egan, Caitlin; Evans, Mary; Foreyt, John P.; Glasser, Stephen P.; Greenway, Frank L.; Gregg, Edward W.; Hazuda, Helen P.; Hill, James O.; Horton, Edward S.; Hubbard, Van S.; Jakicic, John M.; Jeffery, Robert W.; Johnson, Karen C.; Kahn, Steven E.; Kitabchi, Abbas E.; Korytkowski, Mary; Krakoff, Jonathan; Kure, Anne; Lewis, Cora E.; Maschak-Carey, Barbara J.; Michaels, Sara; Montez, Maria G.; Nathan, David M.; Nyenwe, Ebenezer; Patricio, Jennifer; Peters, Anne; Pi-Sunyer, Xavier; Pownall, Henry; Wadden, Thomas A.; Wagenknecht, Lynne E.; Williamson, David F.; Wing, Rena R.; Wyatt, Holly; Yanovski, Susan Z.

    2015-01-01

    Background Long-term effects of behavioral weight loss interventions on diabetes complications are unknown. We assessed whether an intensive lifestyle intervention (ILI) affects the development of nephropathy in Look AHEAD, a multicenter randomized clinical trial in type 2 diabetes. Methods 5145 overweight or obese persons aged 45–76 years with type 2 diabetes were randomized to ILI designed to achieve and maintain weight loss through reduced caloric consumption and increased physical activity or to a diabetes support and education (DSE) group. Randomization to ILI or DSE, in a 1:1 ratio, was implemented in a central web-based data management system, stratified by clinical center, and blocked with random block sizes. Outcomes assessors and laboratory staff were masked to treatment. The interventions ended early because of lack of effect on the primary outcome of cardiovascular disease events. Albuminuria and estimated glomerular filtration rate were prespecified “other” outcomes and were assessed from baseline through 9.6 years (median) of follow-up until the interventions ended. They were combined post-hoc to define the main outcome for this report: very-high-risk chronic kidney disease (CKD) based on the 2013 Kidney Disease Improving Global Outcomes classification. Data were analyzed by intention to treat. The trial is registered as Clinicaltrials.gov NCT00017953. Findings The incidence rate of very-high-risk CKD was 31% lower in ILI than DSE with hazard rates of 0.90 cases/100 person-years in DSE and 0.63 in ILI (difference=0.27 cases/100 person-years, hazard ratio and 95% confidence interval: HR=0.69, 0.55 to 0.87). This effect was partly attributable to reductions in weight, HbA1c, and blood pressure. Interpretation Weight loss should be considered as an adjunct to medical therapies to prevent or delay progression of CKD in overweight or obese persons with type 2 diabetes. Primary Funding National Institute of Diabetes and Digestive and Kidney Diseases

  9. Effect of pioglitazone therapy on high sensitive C-reactive protein and lipid profile in diabetic patients with renal transplantation; a randomize clinical trial

    PubMed Central

    Arashnia, Rana; Roohi-Gilani, Kobra; Karimi-Sari, Hamidreza; Nikjoo, Niloofar; Bahramifar, Ali

    2015-01-01

    Background: Inflammation has a major role in disease lead to renal failure and diabetes mellitus, controlling inflammation in diabetic kidney receivers could decrease morbidity and mortality. Objectives: This study designed for evaluating the efficacy of pioglitazone on C-reactive protein and lipid profile in diabetic kidney transplant receivers. Patients and Methods: In this double blinded clinical trial, 58 diabetic renal transplant receivers, in first month after transplantation, randomized into two groups; receiving insulin and pioglitazone (15 mg tablet daily, group A); and insulin and placebo (group B). Blood pressure, weight, body mass index (BMI) and laboratory data compared in before and after 4-month treatment in two groups by SPSS. Results: Fifty-eight patients with mean age of 44.15 ± 2 years included. There were no significant difference between groups in demographic data and other baseline measured variables (P > 0.05) .The mean weigh and BMI were slightly increased in group A and decreased in group B. The mean hs-CRP was decreased 4.82 mg/dL in group A and 1.93 mg/dL in group B (P = 0.007). The mean total serum cholesterol was significantly decreased 34 mg/dL in group A and 18.07 mg/dL in group B (P = 0.027). The mean serum HDL-C was significantly increased 13.31 mg/dL in group A and 5.89 mg/dl in group B (P < 0.001). Conclusions: Pioglitazone seems to be a safe drug for reducing serum lipids and CRP in kidney transplant receivers with diabetes mellitus in short term. Long term effect of this drug could be evaluated in future studies. PMID:25964889

  10. The Effects of Consumption of Bread Fortified With Soy Bean Flour on Metabolic Profile in Type 2 Diabetic Women: A Cross-over Randomized Controlled Clinical Trial

    PubMed Central

    Moghaddam, Asma Salari; Entezari, Mohammad Hassan; Iraj, Bijan; Askari, Gholam Reza; Maracy, Mohammad Reza

    2014-01-01

    Background: Diabetes mellitus is one of the most common chronic diseases in the world and has become a major threat for global health. Recent studies reported that the soy has beneficial effects in diabetic mellitus patients. The aim of this study was to assess the effects of soybean flour fortified bread consumption on metabolic profile in type 2 diabetic women. Methods: This randomized, cross-over, controlled clinical trial was carried out in 30 type 2 diabetic women. At first, a 2-week run-in period was applied. Then, participants were randomly assigned to either intervention or control groups. Participants in the intervention group were asked to replace 120 g of soybean flour fortified bread with the same amount of their usual bread intake or other cereal products for 6 weeks. After a 4 weeks washout period, participants were crossed over for another 6 weeks. Results: Mean (±standard deviation) age and body mass index of subjects was 45.7 ± 3.8 years and 29.5 ± 3.9 kg/m2, respectively. The results of our study showed no significant effects of soybean flour fortified bread on metabolic profile. We found a reduction in serum triglycerides (change difference: −3.7, P = 0.82), serum low-density lipoprotein-cholesterol (change difference: −11.2, P = 0.50), insulin (change difference: −3.6, P = 0.7), and homeostatic model assessment of insulin resistance (change differences: −0.57, P = 0.45) after 6 weeks but these changes were not statistically significant. No significant effects of soybean flour fortified bread on serum concentrations of fasting blood sugar, glycated hemoglobin, high-density lipoproteins and total cholesterol levels were found. Conclusions: Six weeks consumption of soybean flour fortified bread among diabetic patients had no significant effects on metabolic profile. PMID:25709788

  11. Effect of Replacing Animal Protein with Plant Protein on Glycemic Control in Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Viguiliouk, Effie; Stewart, Sarah E.; Jayalath, Viranda H.; Ng, Alena Praneet; Mirrahimi, Arash; de Souza, Russell J.; Hanley, Anthony J.; Bazinet, Richard P.; Blanco Mejia, Sonia; Leiter, Lawrence A.; Josse, Robert G.; Kendall, Cyril W.C.; Jenkins, David J.A.; Sievenpiper, John L.

    2015-01-01

    Previous research on the effect of replacing sources of animal protein with plant protein on glycemic control has been inconsistent. We therefore conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to assess the effect of this replacement on glycemic control in individuals with diabetes. We searched MEDLINE, EMBASE, and Cochrane databases through 26 August 2015. We included RCTs ≥ 3-weeks comparing the effect of replacing animal with plant protein on HbA1c, fasting glucose (FG), and fasting insulin (FI). Two independent reviewers extracted relevant data, assessed study quality and risk of bias. Data were pooled by the generic inverse variance method and expressed as mean differences (MD) with 95% confidence intervals (CIs). Heterogeneity was assessed (Cochran Q-statistic) and quantified (I2-statistic). Thirteen RCTs (n = 280) met the eligibility criteria. Diets emphasizing a replacement of animal with plant protein at a median level of ~35% of total protein per day significantly lowered HbA1c (MD = −0.15%; 95%-CI: −0.26, −0.05%), FG (MD = −0.53 mmol/L; 95%-CI: −0.92, −0.13 mmol/L) and FI (MD = −10.09 pmol/L; 95%-CI: −17.31, −2.86 pmol/L) compared with control arms. Overall, the results indicate that replacing sources of animal with plant protein leads to modest improvements in glycemic control in individuals with diabetes. Owing to uncertainties in our analyses there is a need for larger, longer, higher quality trials. Trial Registration: ClinicalTrials.gov registration number: NCT02037321. PMID:26633472

  12. A single-blind randomised controlled trial of the effects of a web-based decision aid on self-testing for cholesterol and diabetes. study protocol

    PubMed Central

    2012-01-01

    Background Self-tests, tests on body materials to detect medical conditions, are widely available to the general public. Self-testing does have advantages as well as disadvantages, and the debate on whether self-testing should be encouraged or rather discouraged is still ongoing. One of the concerns is whether consumers have sufficient knowledge to perform the test and interpret the results. An online decision aid (DA) with information on self-testing in general, and test specific information on cholesterol and diabetes self-testing was developed. The DA aims to provide objective information on these self-tests as well as a decision support tool to weigh the pros and cons of self-testing. The aim of this study is to evaluate the effect of the online decision aid on knowledge on self-testing, informed choice, ambivalence and psychosocial determinants. Methods/Design A single blind randomised controlled trial in which the online decision aid 'zelftestwijzer' is compared to short, non-interactive information on self-testing in general. The entire trial will be conducted online. Participants will be selected from an existing Internet panel. Consumers who are considering doing a cholesterol or diabetes self-test in the future will be included. Outcome measures will be assessed directly after participants have viewed either the DA or the control condition. Weblog files will be used to record participants' use of the decision aid. Discussion Self-testing does have important pros and cons, and it is important that consumers base their decision whether they want to do a self-test or not on knowledge and personal values. This study is the first to evaluate the effect of an online decision aid for self-testing. Trial registration Dutch Trial Register: NTR3149 PMID:22216905

  13. Effectiveness of a Peer Support Programme versus Usual Care in Disease Management of Diabetes Mellitus Type 2 regarding Improvement of Metabolic Control: A Cluster-Randomised Controlled Trial

    PubMed Central

    Johansson, Tim; Keller, Sophie; Winkler, Henrike; Weitgasser, Raimund; Sönnichsen, Andreas C.

    2016-01-01

    Aim. Testing the effectiveness of peer support additionally to a disease management programme (DMP) for type 2 diabetes patients. Methods. Unblinded cluster-randomised controlled trial (RCT) involving 49 general practices, province of Salzburg, Austria. All patients enrolled in the DMP were eligible, n = 337 participated (intervention: 148 in 19 clusters; control: 189 in 20 clusters). The peer support intervention ran over 24 months and consisted of peer supporter recruitment and training, and group meetings weekly for physical exercise and monthly for discussion of diabetes related topics. Results. At two-year follow-up, adjusted analysis revealed a nonsignificant difference in HbA1c change of 0.14% (21.97 mmol/mol) in favour of the intervention (95% CI −0.08 to 0.36%, p = 0.22). Baseline values were 7.02 ± 1.25% in the intervention and 7.08 ± 1.25 in the control group. None of the secondary outcome measures showed significant differences except for improved quality of life (EQ-5D-VAS) in controls (4.3 points on a scale of 100; 95% CI 0.08 to 8.53, p = 0.046) compared to the intervention group. Conclusion. Our peer support intervention as an additional DMP component showed no significant effect on HbA1c and secondary outcome measures. Further RTCs with a longer follow-up are needed to reveal whether peer support will have clinically relevant effects. Trial Registration. This trial has been registered with Current Controlled Trials Ltd. (ISRCTN10291077). PMID:26858958

  14. Continuous intraperitoneal insulin infusion in type 1 diabetes: a 6-year post-trial follow-up

    PubMed Central

    2014-01-01

    Background Continuous intraperitoneal insulin infusion (CIPII) with an implantable pump is a treatment option for patients with type 1 diabetes mellitus (T1DM). Aim of the present study was to describe the long-term course of glycaemic control, complications, health related quality of life (HRQOL) and treatment satisfaction among T1DM patients treated with CIPII. Methods Nineteen patients that participated in a randomized cross-over trial comparing CIPII and subcutaneous (SC) therapy in 2006 were followed until 2012. Laboratory, continuous glucose monitoring, HRQOL and treatment satisfaction measurements were performed at the start of the study, the end of the SC-, the end of the CIPII treatment phase in 2006 and during CIPII therapy in 2012. Linear mixed models were used to calculate estimated values and to test differences between the moments in time. Results In 2012, more time was spent in hyperglycaemia than after the CIPII treatment phase in 2006: 37% (95% CI 29, 44) vs. 55% (95% CI 48, 63), mean difference 19.8% (95% CI 3.0, 36.6). HbA1c was 65 mmol/mol (95% CI 60, 71) at the end of the SC treatment phase in 2006, 58 mmol/mol (95% CI 53, 64) at the end of the CIPII treatment phase and 65 mmol/mol (95% CI 60, 71) in 2012, respectively (p > 0.05). In 2012, the median number of grade 2 hypoglycaemic events per week (1 (95% CI 0, 2)) was still significantly lower than during prior SC therapy (3 (95% CI 2, 4)): mean change -1.8 (95% CI -3.4, -0.4). Treatment satisfaction with CIPII was better than with SC insulin therapy and HRQOL remained stable. Pump or catheter dysfunction of the necessitated re-operation in 7 patients. No mortality was reported. Conclusions After 6 years of CIPII treatment, glycaemic regulation is stable and the number of hypoglycaemic events decreased compared to SC insulin therapy. Treatment satisfaction with CIPII is superior to SC insulin therapy, HRQOL is stable and complications are scarce. CIPII is a safe and effective treatment

  15. Randomized Controlled Trial of the Effectiveness of Genetic Counseling and a Distance, Computer-Based, Lifestyle Intervention Program for Adult Offspring of Patients with Type 2 Diabetes: Background, Study Protocol, and Baseline Patient Characteristics

    PubMed Central

    Nishigaki, M.; Tokunaga-Nakawatase, Y.; Nishida, J.; Taru, C.; Miyawaki, I.; Sanada, H.; Kazuma, K.

    2012-01-01

    Relatives of type 2 diabetic patients are at a high risk of developing type 2 diabetes and should be regarded as target of intervention for diabetes prevention. However, it is usually hard to motivate them to implement preventive lifestyle changes, because of lack of opportunity to take advises from medical professionals, inadequate risk perception, and low priority for preventive behavior. Prevention strategy for them therefore should be highly acceptable and suited for them. The parallel, three-group trial is now being conducted to investigate the effects of genetic counseling and/or a computerized behavioral program on the prevention of type 2 diabetes in that population. The preventive strategies used in this study could provide a novel solution to the numbers of genetically high-risk individuals, if found to be effective. The objective of this paper is to describe the background, protocol, and baseline patient characteristics of the trial. PMID:22619705

  16. Effect of paricalcitol on renin and albuminuria in non-diabetic stage III-IV chronic kidney disease: a randomized placebo-controlled trial

    PubMed Central

    2013-01-01

    Background Vitamin D receptor activators reduce albuminuria, and may improve survival in chronic kidney disease (CKD). Animal studies suggest that these pleiotropic effects of vitamin D may be mediated by suppression of renin. However, randomized trials in humans have yet to establish this relationship. Methods In a randomized, placebo-controlled, double-blinded crossover study, the effect of oral paricalcitol (2 μg/day) was investigated in 26 patients with non-diabetic, albuminuric stage III-IV CKD. After treatment, plasma concentrations of renin (PRC), angiotensin II (AngII) and aldosterone (Aldo) were measured. GFR was determined by 51Cr-EDTA clearance. Assessment of renal NO dependency was performed by infusion of NG-monomethyl-L-arginine (L-NMMA). Albumin excretion rate (AER) was analyzed in 24-h urine and during 51Cr-EDTA clearance. Results Paricalcitol did not alter plasma levels of renin, AngII, Aldo, or urinary excretion of sodium and potassium. A modest reduction of borderline significance was observed in AER, and paricalcitol abrogated the albuminuric response to L-NMMA. Conclusions In this randomized, placebo-controlled trial paricalcitol only marginally decreased AER and did not alter circulating levels of renin, AngII or Aldo. The abrogation of the rise in albumin excretion by paricalcitol during NOS blockade may indicate that favourable modulation of renal NO dependency could be involved in mediating reno-protection and survival benefits in CKD. Trial registration ClinicalTrials.gov identifier: NCT01136564 PMID:23889806

  17. Comparison of a Mindful Eating Intervention to a Diabetes Self-Management Intervention among Adults with Type 2 Diabetes: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Miller, Carla K.; Kristeller, Jean L.; Headings, Amy; Nagaraja, Haikady

    2014-01-01

    Mindful eating may be an effective intervention for increasing awareness of hunger and satiety cues, improving eating regulation and dietary patterns, reducing symptoms of depression and anxiety, and promoting weight loss. Diabetes self-management education (DSME), which addresses knowledge, self-efficacy, and outcome expectations for improving…

  18. Patient Engagement and Coaching for Health: The PEACH study – a cluster randomised controlled trial using the telephone to coach people with type 2 diabetes to engage with their GPs to improve diabetes care: a study protocol

    PubMed Central

    Young, Doris; Furler, John; Vale, Margarite; Walker, Christine; Segal, Leonie; Dunning, Patricia; Best, James; Blackberry, Irene; Audehm, Ralph; Sulaiman, Nabil; Dunbar, James; Chondros, Patty

    2007-01-01

    Background The PEACH study is based on an innovative 'telephone coaching' program that has been used effectively in a post cardiac event trial. This intervention will be tested in a General Practice setting in a pragmatic trial using existing Practice Nurses (PN) as coaches for people with type 2 diabetes (T2D). Actual clinical care often fails to achieve standards, that are based on evidence that self-management interventions (educational and psychological) and intensive pharmacotherapy improve diabetes control. Telephone coaching in our study focuses on both. This paper describes our study protocol, which aims to test whether goal focused telephone coaching in T2D can improve diabetes control and reduce the treatment gap between guideline based standards and actual clinical practice. Methods/design In a cluster randomised controlled trial, general practices employing Practice Nurses (PNs) are randomly allocated to an intervention or control group. We aim to recruit 546 patients with poorly controlled T2D (HbA1c >7.5%) from 42 General Practices that employ PNs in Melbourne, Australia. PNs from General Practices allocated to the intervention group will be trained in diabetes telephone coaching focusing on biochemical targets addressing both patient self-management and engaging patients to work with their General Practitioners (GPs) to intensify pharmacological treatment according to the study clinical protocol. Patients of intervention group practices will receive 8 telephone coaching sessions and one face-to-face coaching session from existing PNs over 18 months plus usual care and outcomes will be compared to the control group, who will only receive only usual care from their GPs. The primary outcome is HbA1c levels and secondary outcomes include cardiovascular disease risk factors, behavioral risk factors and process of care measures. Discussion Understanding how to achieve comprehensive treatment of T2D in a General Practice setting is the focus of the PEACH

  19. Diabetic patients' willingness to use tele-technology to manage their disease – A descriptive study.

    PubMed Central

    Saddik, Basema; Al-Dulaijan, Norah

    2015-01-01

    Objectives: Diabetes mellitus is a public health concern worldwide. TeleHealth technology may be an effective tool for empowering patients in the self-management of diabetes mellitus. However despite the great impact of diabetes on healthcare in Saudi Arabia, no research has investigated diabetic patients' willingness to use this technology. This study investigates diabetic patients' willingness to use tele-technology as a tool to monitor their disease. Methods: Data were collected from diabetic patients attending the diabetes education clinic at the Ministry of National Guard Health Affairs (MNGHA) in the Eastern region of Saudi Arabia over a three month period. A survey was developed which measured patients' willingness to use tele-technology in the self-management of their diabetes as well as their perceived expectations from the technology. Results: The study found that the majority of patients were willing to use tele-technology to self- monitor their diabetes. However, a minority (11.3%) indicated willingness to use the system daily and only half indicated preference to use it once a week (53.8%). Patients who were younger, had higher education levels, were employed, had internet access and had Type II diabetes were significantly more likely to report willingness to use the technology. Conclusions: Diabetic patients could be ready to play a more active role in their care if given the opportunity. Results from this study could serve as a baseline for future studies to develop targeted interventions by trialing tele-technology on a sample of the diabetic population. Patients with diabetes need to be in charge of their own care in order to improve health outcomes across the country. PMID:26284148

  20. Effects of Ezetimibe/Simvastatin and Rosuvastatin on Oxidative Stress in Diabetic Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Villegas-Rivera, Geannyne; Román-Pintos, Luis Miguel; Cardona-Muñoz, Ernesto Germán; Arias-Carvajal, Oscar; Rodríguez-Carrizalez, Adolfo Daniel; Troyo-Sanromán, Rogelio; Pacheco-Moisés, Fermín Paul; Moreno-Ulloa, Aldo; Miranda-Díaz, Alejandra Guillermina

    2015-01-01

    Objective. To evaluate the effects of ezetimibe/simvastatin (EZE/SIMV) and rosuvastatin (ROSUV) on oxidative stress (OS) markers in patients with diabetic polyneuropathy (DPN). Methods. We performed a randomized, double-blind, placebo-controlled phase III clinical trial in adult patients with Type 2 Diabetes Mellitus (T2DM) and DPN, as evaluated by composite scores and nerve conduction studies (NCS). Seventy-four subjects with T2DM were allocated 1 : 1 : 1 to placebo, EZE/SIMV 10/20 mg, or ROSUV 20 mg for 16 weeks. All patients were assessed before and after treatment: primary outcomes were lipid peroxidation (LPO), and nitric oxide (NO) surrogate levels in plasma; secondary outcomes included NCS, neuropathic symptom scores, and metabolic parameters. Data were expressed as mean ± SD or SEM, frequencies, and percentages; we used nonparametric analysis. Results. LPO levels were reduced in both statin arms after 16 weeks of treatment (p < 0.05 versus baseline), without changes in the placebo group. NO levels were not significantly affected by statin treatment, although a trend towards significance concerning increased NO levels was noted in both statin arms. No significant changes were observed for the NCS or composite scores. Discussion. EZE/SIMV and ROSUV are superior to placebo in reducing LPO in subjects with T2DM suffering from polyneuropathy. This trial is registered with NCT02129231. PMID:26290682

  1. Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the stepping up to insulin cluster randomized controlled trial protocol

    PubMed Central

    2014-01-01

    Background Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care. Methods This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D. 224 patients between the ages of 18 and 80 years with T2D, on two or more oral hypoglycaemic agents and with an HbA1c ≥7.5% in the last six months will be recruited from 74 general practices. The unit of randomization is the practice. Primary outcome is change in glycated haemoglobin HbA1c (measured as a continuous variable). We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5% lower than control group at 12 months follow up. Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of <7.0%. We will also collect data on patient psychosocial outcomes and healthcare utilization and costs. Discussion The study is a pragmatic translational

  2. Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial

    PubMed Central

    Haidar, Ahmad; Legault, Laurent; Dallaire, Maryse; Alkhateeb, Ammar; Coriati, Adèle; Messier, Virginie; Cheng, Peiyao; Millette, Maude; Boulet, Benoit; Rabasa-Lhoret, Rémi

    2013-01-01

    Background: Most patients with type 1 diabetes do not achieve their glycemic targets. We aimed to assess the efficacy of glucose-responsive insulin and glucagon closed-loop delivery for controlling glucose levels in adults with type 1 diabetes. Methods: We conducted a randomized crossover trial involving 15 adults with type 1 diabetes, comparing standard insulin-pump therapy with dual-hormone, closed-loop delivery. Patients were admitted twice to a clinical research facility and received, in random order, both treatments. Each 15-hour visit (from 1600 to 0700) included an evening exercise session, followed by a medium-sized meal, a bedtime snack and an overnight stay. During visits that involved closed-loop delivery, basal insulin and glucagon miniboluses were delivered according to recommendations based on glucose sensor readings and a predictive dosing algorithm at 10-minute intervals. During visits involving standard insulin-pump therapy (control visits), patients used conventional treatment. Results: Dual-hormone closed-loop delivery increased the percentage of time for which patients’ plasma glucose levels were in the target range (median 70.7% [interquartile range (IQR) 46.1%–88.4%] for closed-loop delivery v. 57.3% [IQR 25.2%–71.8%] for control, p = 0.003) and decreased the percentage of time for which plasma glucose levels were in the low range (bottom of target range [< 4.0 mmol/L], 0.0% [IQR 0.0%–3.0%] for closed-loop delivery v. 10.2% [IQR 0.0%–13.0%] for control, p = 0.01; hypoglycemia threshold [< 3.3 mmol/L], 0.0% [IQR 0.0%–0.0%] for closed-loop delivery v. 2.8% [IQR 0.0%–5.9%] for control, p = 0.006). Eight participants (53%) had at least 1 hypoglycemic event (plasma glucose < 3.0 mmol/L) during standard treatment, compared with just 1 participant (7%) during closed-loop treatment (p = 0.02). Interpretation: Dual-hormone, closed-loop delivery guided by advanced algorithms improved short-term glucose control and reduced the risk of

  3. Detection of silent myocardial ischemia in asymptomatic patients with diabetes: results of a randomized trial and meta-analysis assessing the effectiveness of systematic screening

    PubMed Central

    2011-01-01

    Background Most guidelines recommend a systematic screening of asymptomatic high risk patients with diabetes for silent ischemia, but the clinical benefit of this strategy has not been demonstrated compared with the simple control of cardiovascular risk factors. We sought to determine whether referring asymptomatic diabetic patients for screening of silent ischemia decreases the risk of cardiovascular events compared with usual care. Methods DYNAMIT was a prospective, randomized, open, blinded end-point multicenter trial run between 2000 and 2005, with a 3.5 year mean follow-up in ambulatory care in 45 French hospitals. The study included 631 male and female with diabetes aged 63.9 ± 5.1 years, with no evidence of coronary artery disease and at least 2 additional cardiovascular risk factors, receiving appropriate medical treatment. The patients were randomized centrally to either screening for silent ischemia using a bicycle exercise test or Dipyridamole Single Photon Emission Computed Tomography (N = 316), or follow-up without screening (N = 315). The main study end point was time to death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention. The results of a meta-analysis of DYNAMIT and DIAD, a similar study, are also presented. Results The study was discontinued prematurely because of difficulties in recruitment and a lower-than expected event rate. Follow-up was complete for 98.9% patients regarding mortality and for 97.5% regarding the main study end point. Silent ischemia detection procedure was positive or uncertain in 68 (21.5%) patients of the screening group. There was no significant difference between the screening and the usual care group for the main outcome (hazard ratio = 1.00 95%CI 0.59 to 1.71). The meta-analysis of these and DIAD results gave similar results, with narrower confidence intervals for each endpoint. Conclusions These results suggest that the

  4. Organizational Vitality in Student Affairs.

    ERIC Educational Resources Information Center

    Barnes, Stephen F.; O'Donnell, Jo Anne

    Institutional vitality, a broad measure of the quality of organizational life at colleges and universities, has not been systematically addressed in the literature. To identify management and personnel practices which contribute to institutional vitality within student affairs divisions, a two-stage methodology was employed. First, an…

  5. Indigenous Affairs = Asuntos Indigenas, 1998.

    ERIC Educational Resources Information Center

    Indigenous Affairs, 1998

    1998-01-01

    This document contains the four 1998 English-language issues of Indigenous Affairs and the four corresponding issues in Spanish. These periodicals provide a resource on the history, current conditions, and struggles for self-determination and human rights of indigenous peoples around the world. The first issue is a theme issue on the indigenous…

  6. Online Education in Public Affairs

    ERIC Educational Resources Information Center

    Ginn, Martha H.; Hammond, Augustine

    2012-01-01

    This exploratory study provides an overview of the current landscape of online education in the fields of Master of Public Administration and Master of Public Policy (MPA/MPP) utilizing a dataset compiled from content analysis of MPA/MPP programs' websites and survey of 96 National Association of Schools of Public Affairs and Administration…

  7. Office Automation in Student Affairs.

    ERIC Educational Resources Information Center

    Johnson, Sharon L.; Hamrick, Florence A.

    1987-01-01

    Offers recommendations to assist in introducing or expanding computer assistance in student affairs. Describes need for automation and considers areas of choosing hardware and software, funding and competitive bidding, installation and training, and system management. Cites greater efficiency in handling tasks and data and increased levels of…

  8. Indigenous Affairs = Asuntos Indigenas, 2000.

    ERIC Educational Resources Information Center

    Indigenous Affairs, 2000

    2000-01-01

    This document contains the four English-language issues of Indigenous Affairs published in 2000 and four corresponding issues in Spanish. The Spanish issues contain all or some of the articles contained in the English issues plus additional articles on Latin America. These periodicals provide a resource on the history, current conditions, and…

  9. Employment Practices in Student Affairs.

    ERIC Educational Resources Information Center

    McIntire, David A.; Carpenter, D. Stanley

    1981-01-01

    Investigated job search and hiring practices in student affairs work. Questionnaires sent to member institutions of the National Association of Student Personnel Administrators indicated the extensive use of newspapers to advertise positions. Institutions placed a high level of importance on effective resumes and reference letters. (RC)

  10. Indigenous Affairs = Asuntos Indigenas, 1997.

    ERIC Educational Resources Information Center

    Indigenous Affairs, 1997

    1997-01-01

    This document contains the three 1997 English-language issues of Indigenous Affairs and the three corresponding issues in Spanish. (The last two quarterly issues were combined.) These periodicals provide a resource on the history, current conditions, and struggles for self-determination and human rights of indigenous peoples around the world.…

  11. Sustainability, Student Affairs, and Students

    ERIC Educational Resources Information Center

    Kerr, Kathleen G.; Hart-Steffes, Jeanne S.

    2012-01-01

    Colleges and universities are developing both the next generation of leaders as well as state-of-the-art technology that allow climate reduction aspirations and triple bottom-line outcomes to become realities. Divisions of student affairs play a crucial role in the sustainability movement in colleges and universities. The technology-savvy,…

  12. Indigenous Affairs = Asuntos Indigenas, 1996.

    ERIC Educational Resources Information Center

    Indigenous Affairs, 1996

    1996-01-01

    This document contains the four 1996 English-language issues of Indigenous Affairs and the four corresponding issues in Spanish. These newsletters provide a resource on the history, current conditions, and struggles for self-determination and human rights of indigenous peoples around the world. Articles on the United States and Canada (1) discuss…

  13. Low-Intensity Self-Management Intervention for Persons With Type 2 Diabetes Using a Mobile Phone-Based Diabetes Diary, With and Without Health Counseling and Motivational Interviewing: Protocol for a Randomized Controlled Trial

    PubMed Central

    Holmen, Heidi; Torbjørnsen, Astrid; Wahl, Astrid Klopstad; Grøttland, Astrid; Småstuen, Milada Cvancarova; Elind, Elisabeth; Bergmo, Trine Strand; Breivik, Elin; Årsand, Eirik

    2013-01-01

    Background The present study protocol is designed to cover the Norwegian part of the European Union Collaborative Project—REgioNs of Europe WorkINg together for HEALTH (RENEWING HEALTH). Self-management support is an important element of care for persons with type 2 diabetes (T2D) for achieving metabolic control and positive lifestyle changes. Telemedicine (TM) with or without health counseling may become an important technological aid for self-management and may provide a user-centered model of care. In spite of many earlier studies on TM, there remains a lack of consensus in research findings about the effect of TM interventions. Objective The aim of RENEWING HEALTH is to validate and evaluate innovative TM tools on a large scale through a common evaluation, making it easier for decision makers to choose the most efficient and cost-effective technological interventions. The Norwegian pilot study evaluates whether the introduction of a mobile phone with a diabetes diary application together with health counseling intervention produces benefits in terms of the desired outcomes, as reflected in the hemoglobin A1c level, health-related quality of life, behavior change, and cost-effectiveness. Methods The present study has a mixed-method design comprising a three-armed prospective randomized controlled trial and qualitative interviews with study data collected at three time points: baseline, after 4 months, and after 1 year. The patients’ registrations on the application are recorded continuously and are sent securely to a server. Results The inclusion of patients started in March 2011, and 100% of the planned sample size is included (N=151). Of all the participants, 26/151 patients (17.2%) are lost to follow-up by now, and 11/151 patients (7.3%) are still in the trial. Results of the study protocol will be presented in 2014. Conclusions The key goals of this trial are to investigate the effect of an electronic diabetes diary app with and without health counseling

  14. Alpha-Lipoic Acid and Antioxidant Diet Help to Improve Endothelial Dysfunction in Adolescents with Type 1 Diabetes: A Pilot Trial

    PubMed Central

    Scaramuzza, Andrea; Giani, Elisa; Redaelli, Francesca; Ungheri, Saverio; Macedoni, Maddalena; Giudici, Valentina; Bosetti, Alessandra; Ferrari, Matteo; Zuccotti, Gian Vincenzo

    2015-01-01

    After evaluating the prevalence of early endothelial dysfunction, as measured by means of reactive hyperemia in adolescents with type 1 diabetes, we started a 6-month, double-blind, randomized trial to test the efficacy of an antioxidant diet (± alpha-lipoic acid supplementation) to improve endothelial dysfunction. Seventy-one children and adolescents, ages 17 ± 3.9 yrs, with type 1 diabetes since 9.5 ± 5.3 yrs, using intensified insulin therapy, were randomized into 3 arms: (a) antioxidant diet 10.000 ORAC + alpha-lipoic acid; (b) antioxidant diet 10.000 ORAC + placebo; (c) controls. BMI, blood pressure, fasting lipid profile, HbA1c, insulin requirement, dietary habits, and body composition were determined in each patient. An antioxidant diet significantly improved endothelial dysfunction when supplemented with alpha-lipoic acid, unlike diet with placebo or controls. A significant reduction in bolus insulin was also observed. We speculate that alpha-lipoic acid might have an antioxidant effect in pediatric diabetes patients by reducing insulin. PMID:26171398

  15. Medical assistant coaching to support diabetes self-care among low-income racial/ethnic minority populations: Randomized controlled trial

    PubMed Central

    Ruggiero, Laurie; Riley, Barth B.; Hernandez, Rosalba; Quinn, Lauretta T.; Gerber, Ben S.; Castillo, Amparo; Day, Joseph; Ingram, Diana; Wang, Yamin; Butler, Paula

    2014-01-01

    Innovative, culturally tailored strategies are needed to extend diabetes education and support efforts in low-resourced primary care practices serving racial/ethnic minority groups. A randomized controlled trial examined the effect of a diabetes self-care coaching intervention delivered by medical assistants and the joint effect of intervention and ethnicity over time. The randomized repeated-measures design included 270 low-income African American and Hispanic/Latino patients with type 2 diabetes. The one-year clinic- and telephone-based medical assistant coaching intervention was culturally tailored and guided by theoretical frameworks. A1C was obtained, and a self-care measure was completed at baseline, 6 months, and 12 months. Data were analyzed using mixed-effects models with and without adjustment for covariates. There was significant overall improvement in mean self-care scores across time, but no intervention effect. Results revealed differences in self-care patterns across racial/ethnic subgroups. No differences were found for A1C levels across time or group. PMID:24569698

  16. The Effect of Non-surgical Periodontal Therapy on Hemoglobin A1c Levels in Persons with Type 2 Diabetes and Chronic Periodontitis: A Randomized Clinical Trial

    PubMed Central

    Engebretson, Steven P.; Hyman, Leslie G.; Michalowicz, Bryan S.; Schoenfeld, Elinor R.; Gelato, Marie C.; Hou, Wei; Seaquist, Elizabeth R.; Reddy, Michael S.; Lewis, Cora E.; Oates, Thomas W.; Tripathy, Devjit; Katancik, James A.; Orlander, Philip R.; Paquette, David W.; Hanson, Naomi Q.; Tsai, Michael Y.

    2014-01-01

    Importance Chronic periodontitis, a destructive inflammatory disorder of the supporting structures of the teeth, is prevalent in patients with diabetes. Limited evidence suggests that periodontal therapy may improve glycemic control. Objective To determine if non-surgical periodontal treatment reduces hemoglobin A1c (HbA1c) in persons with type 2 diabetes (DM) and moderate to advanced chronic periodontitis. Design, Setting and Participants The Diabetes and Periodontal Therapy Trial (DPTT) is a 6-month, single-masked, randomized, multi-center clinical trial. Participants had DM, were taking stable doses of medications, had HbA1c ≥7% and <9%, and untreated periodontitis. Five hundred fourteen participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with five academic medical centers. Intervention The treatment group (n=257) received scaling and root planing plus chlorhexidine oral rinse at baseline, and supportive periodontal therapy at three and six months. The control group (n=257) received no treatment for six months. Main Outcome Measure Difference in HbA1c change from baseline between groups at six months. Secondary outcomes included changes in probing pocket depths, clinical attachment loss, bleeding on probing, gingival index, fasting glucose, and the Homeostasis Model Assessment (HOMA2). Results Enrollment was stopped early due to futility. At 6 months, the periodontal therapy group increased HbA1c 0.17% (1.0) (mean (SD)) compared to 0.11% (1.0) in the control group, with no significant difference between groups based on a linear regression model adjusting for clinical site (mean difference = -0.05%; 95% Confidence Interval (CI): -0.23%, 0.12%; p=0.55). Probing depth, clinical attachment loss, bleeding on probing and gingival index measures improved in the treatment group compared to the control group at six months with adjusted between-group differences of 0.33mm (95% CI: 0.26, 0.39), 0

  17. Binge eating and weight loss outcomes in overweight and obese individuals with type 2 diabetes: Results from the Look AHEAD trial

    PubMed Central

    Gorin, Amy A.; Niemeier, Heather M.; Hogan, Patricia; Coday, Mace; Davis, Cralen; DiLillo, Vicki G.; Gluck, Marci E.; Wadden, Thomas A.; West, Delia S.; Williamson, Donald; Yanovski, Susan Z.

    2009-01-01

    Context Binge eating (BE) is common in overweight and obese individuals with type 2 diabetes yet little is known about how BE affects weight loss in this population. Objective To determine whether BE was related to 1-year weight losses in overweight and obese individuals with type 2 diabetes participating in an ongoing clinical trial. Design and Setting Look AHEAD is a randomized controlled trial examining the long-term effect of intentional weight loss on CVD in overweight and obese adults with type 2 diabetes. Participants Overweight and obese individuals, 45–76 years old, with type 2 diabetes (n=5145). Interventions Participants were randomly assigned to an intensive lifestyle intervention (ILI) or to enhanced usual care (DSE). Main outcome measures At baseline and 1-year, participants had their weight measured and completed a fitness test and self-report measures of BE and dietary intake. Four groups were created based on BE status at baseline and 1-year (Yes/Yes, No/No, Yes/No, No/Yes). Analyses controlled for baseline differences between binge eaters and non-binge eaters. Results Most individuals (85.4%) did not report BE at baseline or 1-year, 7.5% reported BE only at baseline, 3.7% reported BE at both times, and 3.4% reported BE only at 1-year, with no differences between ILI and DSE conditions (p=.14). Across ILI and DSE, greater weight losses were observed in participants who stopped BE at 1-year (5.3±.4 kg) and in those who reported no BE at either time point (4.8±.1 kg) than in those who continued to BE (3.1±.6 kg) and those who began BE at 1-year (3.0±.6 kg) (p=.0003). Post hoc analyses suggested these differences were due to changes in caloric intake. Conclusions Overweight and obese individuals with type 2 diabetes who stop binge eating appear just as successful at weight loss as non-binge eaters after one year of treatment. PMID:19047532

  18. The Effects of 6 Isocaloric Meals Pattern on Blood Lipid Profile, Glucose, Hemoglobin A1c, Insulin and Malondialdehyde in Type 2 Diabetic Patients: A Randomized Clinical Trial

    PubMed Central

    Salehi, Moosa; Kazemi, Asma; Hasan Zadeh, Jafar

    2014-01-01

    Background: The present clinical trial study aims at investigating the effect of daily energy intake in 6 isocaloric meals in comparison with the current meal pattern (3 meals and 2 small snacks per day) on type 2 diabetes risk markers in diabetes during 3-month period. Methods: Eighty four type 2 diabetes patients were randomly divided into 6 isocaloric meal diet or a balanced diet (3 meals and 2 snacks previous meal pattern). The planned reduced calorie diets for both groups were identical except for the meal pattern. Blood samples were analyzed before and after the investigation for fasting blood sugar (FBS), two-hour post-prandial glucose (2hPP), insulin, hemoglobin A1c (HbA1c), total cholesterol, triglyceride, HDL-C, LDL-C, and molondialdehyde (MDA) concentrations. Results: HbA1c (P=0.00) and body mass index (BMI) (P=0.04) values decreased significantly in the 6 isocaloric meal pattern compared with the controls. There were no significant differences in fasting serum glucose (P=0.09), insulin (P=0.65), total cholesterol (P=0.32), LDL-C (P=0.43), HDL-C (P=0.40) cholesterol, triglyceride (P=0.40), MDA (P=0.13) and 2hPP serum glucose (P=0.30) concentrations between the 6 isocaloric meal and tradition meal pattern. Conclusion: Six isocaloric meal pattern in comparison with the current meal pattern led to weight loss and improved glycemic control. Serum lipid profile and MDA did not change significantly. Trial Registration Number: IRCT201205179780N1 PMID:25242841

  19. Low-glycaemic index diet to improve glycaemic control and cardiovascular disease in type 2 diabetes: design and methods for a randomised, controlled, clinical trial

    PubMed Central

    Chiavaroli, Laura; Mirrahimi, Arash; Ireland, Christopher; Mitchell, Sandra; Sahye-Pudaruth, Sandhya; Coveney, Judy; Olowoyeye, Omodele; Maraj, Tishan; Patel, Darshna; de Souza, Russell J; Augustin, Livia S A; Bashyam, Balachandran; Blanco Mejia, Sonia; Nishi, Stephanie K; Leiter, Lawrence A; Josse, Robert G; McKeown-Eyssen, Gail; Moody, Alan R; Berger, Alan R; Kendall, Cyril W C; Sievenpiper, John L; Jenkins, David J A

    2016-01-01

    Introduction Type 2 diabetes (T2DM) produces macrovascular and microvascular damage, significantly increasing the risk of cardiovascular disease (CVD), renal failure and blindness. As rates of T2DM rise, the need for effective dietary and other lifestyle changes to improve diabetes management become more urgent. Low-glycaemic index (GI) diets may improve glycaemic control in diabetes in the short term; however, there is a lack of evidence on the long-term adherence to low-GI diets, as well as on the association with surrogate markers of CVD beyond traditional risk factors. Recently, advances have been made in measures of subclinical arterial disease through the use of MRI, which, along with standard measures from carotid ultrasound (CUS) scanning, have been associated with CVD events. We therefore designed a randomised, controlled, clinical trial to assess whether low-GI dietary advice can significantly improve surrogate markers of CVD and long-term glycaemic control in T2DM. Methods and analysis 169 otherwise healthy individuals with T2DM were recruited to receive intensive counselling on a low-GI or high-cereal fibre diet for 3 years. To assess macrovascular disease, MRI and CUS are used, and to assess microvascular disease, retinal photography and 24-hour urinary collections are taken at baseline and years 1 and 3. Risk factors for CVD are assessed every 3 months. Ethics and dissemination The study protocol and consent form have been approved by the research ethics board of St. Michael's Hospital. If the study shows a benefit, these data will support the use of low-GI and/or high-fibre foods in the management of T2DM and its complications. Trial Registration number NCT01063374; Pre-results. PMID:27388364

  20. Pleiotropic effects of sitagliptin versus voglibose in patients with type 2 diabetes inadequately controlled via diet and/or a single oral antihyperglycemic agent: a multicenter, randomized trial

    PubMed Central

    Matsushima, Yukiko; Takeshita, Yumie; Kita, Yuki; Otoda, Toshiki; Kato, Ken-ichiro; Toyama-Wakakuri, Hitomi; Akahori, Hiroshi; Shimizu, Akiko; Hamaguchi, Erika; Nishimura, Yasuyuki; Kanamori, Takehiro; Kaneko, Shuichi; Takamura, Toshinari

    2016-01-01

    Purpose A step-up strategy for diet therapy and/or single oral antihyperglycemic agent (OHA) regimens has not yet been established. The aim of this study was to evaluate hemoglobin A1c (HbA1c) as a primary end point, and the pleiotropic effects on metabolic and cardiovascular parameters as secondary end points, of sitagliptin versus voglibose in patients with type 2 diabetes with inadequate glycemic control while on diet therapy and/or treatment with a single OHA. Methods In this multicenter, randomized, open-label, parallel-group trial, a total of 260 patients with inadequately controlled type 2 diabetes (HbA1c levels >6.9%) were randomly assigned to receive either sitagliptin (50 mg, once daily) or voglibose (0.6 mg, thrice daily) for 12 weeks. The primary end point was HbA1c levels. Results Patients receiving sitagliptin showed a significantly greater decrease in HbA1c levels (−0.78±0.69%) compared with those receiving voglibose (−0.30±0.78%). Sitagliptin treatment also lowered serum alkaline phosphatase levels and increased serum creatinine, uric acid, cystatin-C and homeostasis model assessment-β values. Voglibose increased low-density lipoprotein-cholesterol levels and altered serum levels of several fatty acids, and increased Δ-5 desaturase activity. Both drugs increased serum adiponectin. The incidence of adverse events (AEs) was significantly lower in the sitagliptin group, due to the decreased incidence of gastrointestinal AEs. Conclusions Sitagliptin shows superior antihyperglycemic effects compared with voglibose as a first-line or second-line therapy. However, both agents possess unique pleiotropic effects that lead to reduced cardiovascular risk in Japanese people with type 2 diabetes. Trial registration number UMIN 000003503. PMID:27110370

  1. Modest Salt Reduction Lowers Blood Pressure and Albumin Excretion in Impaired Glucose Tolerance and Type 2 Diabetes Mellitus: A Randomized Double-Blind Trial.

    PubMed

    Suckling, Rebecca J; He, Feng J; Markandu, Nirmala D; MacGregor, Graham A

    2016-06-01

    The role of salt restriction in patients with impaired glucose tolerance and diabetes mellitus is controversial, with a lack of well controlled, longer term, modest salt reduction trials in this group of patients, in spite of the marked increase in cardiovascular risk. We carried out a 12-week randomized double-blind, crossover trial of salt restriction with salt or placebo tablets, each for 6 weeks, in 46 individuals with diet-controlled type 2 diabetes mellitus or impaired glucose tolerance and untreated normal or high normal blood pressure (BP). From salt to placebo, 24-hour urinary sodium was reduced by 49±9 mmol (2.9 g salt). This reduction in salt intake led to fall in clinic BP from 136/81±2/1 mm Hg to 131/80±2/1 mm Hg, (systolic BP; P<0.01). Mean ambulatory 24-hour BP was reduced by 3/2±1/1 mm Hg (systolic BP, P<0.01 and diastolic BP, P<0.05), and albumin/creatinine ratio was reduced from 0.73 mg/mmol (0.5-1.5) to 0.64 mg/mmol (0.3-1.1; P<0.05). There was no significant change in fasting glucose, hemoglobin A1c, or insulin sensitivity. These results demonstrate that a modest reduction in salt intake, to approximately the amount recommended in public health guidelines, leads to significant and clinically relevant falls in BP in individuals who are early on in the progression of diabetes mellitus with normal or mildly raised BP. The reduction in urinary albumin excretion may carry additional benefits in reducing cardiovascular disease above the effects on BP. PMID:27160199

  2. The Effect of Purslane Seeds on Biomarkers of Oxidative Stress in Diabetic Patients: A Randomized Controlled Cross-over Clinical Trial

    PubMed Central

    Zakizadeh, Elahe; Faghihimani, Elham; Saneei, Parvane; Esmaillzadeh, Ahmad

    2015-01-01

    Background: This study was designed to examine the effects of purslane seeds on biomarkers of oxidative stress in type 2 diabetic patients. Methods: This cross-over randomized controlled clinical trial was conducted on 40 patients with type 2 diabetes. Participants were randomly assigned to receive either 10 g/day purslane seeds with 240 cc low-fat yogurt (intervention group) or only 240 cc low-fat yogurt (as a control group) for 5 weeks. After a 2-week washout period, subjects were moved to the alternate arm for an additional 5 weeks. At baseline and end of each study phase, fasting blood samples were collected to quantify biomarkers of oxidative stress. Results: We observed a slight decrease in plasma total antioxidant capacity in both groups, however, between-group changes were not significant (−2.67 vs. −2.95 μg/dL, P = 0.94). Plasma malondialdehyde in purslane group increased slightly, however, we observed no significant effect in the control group (1.62 vs. −0.47 μg/dL, P = 0.58). Although both groups had a slight reduction in plasma oxidized low-density lipoprotein (ox-LDL), we failed to find any significant effect of purslane on plasma ox-LDL (−1.06 vs. −1.71 μg/dL, P = 0.85). Conclusions: This cross-over clinical trial revealed that consumption of purslane seeds for 5 weeks in type 2 diabetic patients did not result in improved oxidative stress. PMID:26605016

  3. Glucose- and glycaemic factor-lowering effects of probiotics on diabetes: a meta-analysis of randomised placebo-controlled trials.

    PubMed

    Sun, Jing; Buys, Nicholas J

    2016-04-01

    This meta-analysis examined the effect of probiotics on glucose and glycaemic factors in diabetes and its associated risk factors. All randomised-controlled trials published in English in multiple databases from January 2000 to June 2015 were systematically searched. Only studies that addressed glucose- and glycaemic-related factors as outcome variables were included. The main outcomes of interest in trials were mean changes in glucose, HbA1c, insulin and homoeostasis model assessment-estimated insulin resistance (HOMA-IR). Using the Physiotherapy Evidence Database (PEDro) scale to assess the quality of studies, a total of eleven studies with 614 subjects were included. The pooled mean difference and effect size with a 95 % CI were extracted using a random-effect model. It was found that there are statistically significant pooled mean differences between the probiotics and the placebo-controlled groups on the reduction of glucose (-0·52 mmol/l, 95 % CI -0·92, -0·11 mmol/l; P=0·01) and HbA1c (-0·32 %, 95 % CI -0·57, -0·07 %; P=0·01). There was no statistically significant pooled mean difference between the probiotics and the placebo-controlled groups on the reduction of insulin (-0·48 µIU/ml, 95 % CI -1·34, 0·38 µIU/ml; P=0·27) and HOMA-IR (pooled effect of -0·44, 95 % CI -1·57, 0·70; P=0·45). Meta-regression analysis identified that probiotics had significant effects on reduction of glucose, HbA1c, insulin and HOMA-IR in participants with diabetes, but not in participants with other risk factors. The present meta-analysis suggested that probiotics may be used as an important dietary supplement in reducing the glucose metabolic factors associated with diabetes. PMID:26899960

  4. Design of a Randomized Controlled Trial of a Web-Based Intervention to Reduce Cardiovascular Disease Risk Factors Among Remote Reservation–Dwelling American Indian Adults with Type 2 Diabetes

    PubMed Central

    Chubak, Jessica; O’Connell, Joan; Ramos, Maria C.; Jensen, Julie; Jobe, Jared B.

    2012-01-01

    We describe a randomized controlled trial, the Lakota Oyate Wicozani Pi Kte (LOWPK) trial, which was designed to determine whether a Web-based diabetes and nutritional intervention can improve risk factors related to cardiovascular disease (CVD) among a group of remote reservation–dwelling adult American Indian men and women with type 2 diabetes who are at high risk for CVD. Enrollment on a rolling basis of 180 planned participants began during 2009; an average 18-month follow-up was completed by June 2011. The primary outcome variable is change in glycosylated hemoglobin level after an average 18-month follow-up period. Secondary outcome variables include changes in low-density lipoprotein cholesterol, systolic blood pressure, body mass index, and smoking status, as well as an evaluation of intervention cost-effectiveness. If effective, the LOWPK trial may serve as a guide for future chronic disease intervention trials in remote, technologically challenged settings. PMID:23001642

  5. Design of a randomized controlled trial of a web-based intervention to reduce cardiovascular disease risk factors among remote reservation-dwelling American Indian adults with type 2 diabetes.

    PubMed

    Henderson, Jeffrey A; Chubak, Jessica; O'Connell, Joan; Ramos, Maria C; Jensen, Julie; Jobe, Jared B

    2012-08-01

    We describe a randomized controlled trial, the Lakota Oyate Wicozani Pi Kte (LOWPK) trial, which was designed to determine whether a Web-based diabetes and nutritional intervention can improve risk factors related to cardiovascular disease (CVD) among a group of remote reservation-dwelling adult American Indian men and women with type 2 diabetes who are at high risk for CVD. Enrollment on a rolling basis of 180 planned participants began during 2009; an average 18-month follow-up was completed by June 2011. The primary outcome variable is change in glycosylated hemoglobin level after an average 18-month follow-up period. Secondary outcome variables include changes in low-density lipoprotein cholesterol, systolic blood pressure, body mass index, and smoking status, as well as an evaluation of intervention cost-effectiveness. If effective, the LOWPK trial may serve as a guide for future chronic disease intervention trials in remote, technologically challenged settings. PMID:23001642

  6. Design Features of the Diabetes and Periodontal Therapy Trial (DPTT): A Multicenter Randomized Single-Masked Clinical Trial Testing the Effect of Non-surgical Periodontal Therapy on Glycosylated Hemoglobin (HbA1c) Levels in Subjects with Type 2 Diabetes and Chronic Periodontitis

    PubMed Central

    2013-01-01

    Background Evidence suggests that periodontitis is associated with prevalent and incident type 2 diabetes mellitus (T2DM), raising the question of whether periodontitis treatment may improve glycemic control in patients with T2DM. Meta-analyses of mostly small clinical trials suggest that periodontitis treatment results in a modest reduction in glycosylated hemoglobin (Hb) A1c. Purpose The purpose of the Diabetes and Periodontal Therapy Trial (DPTT) was to determine if periodontal treatment reduces HbA1c in patients with T2DM and periodontitis. Methods DPTT was a phase-III, single-masked, multi-center, randomized trial with a planned enrollment of 600 participants. Participants were randomly assigned to receive periodontal treatment immediately (Treatment Group) or after 6 months (Control Group). HbA1c values and clinical periodontal measures were determined at baseline and 3 and 6 months following randomization. Medication usage and dosing were assessed at each visit. Periodontal treatment consisted of scaling and root planing for a minimum of two 90-minute sessions, plus the use of an antibacterial mouth rinse for at least 32 days afterwards. The primary outcome was change in HbA1c from baseline to 6 months and the trial was powered to detect a between-group difference of 0.6%. Secondary outcomes included changes in periodontal clinical measures, fasting plasma glucose, the Homeostasis Model Assessment (HOMA2) and the need for rescue diabetes or periodontal therapy. Conclusion Dental and medical researchers collaborated to recruit, treat and monitor participants with two chronic diseases to determine if treatment of one condition affects the status of the other. PMID:24080100

  7. Effects of a Multicomponent Life-Style Intervention on Weight, Glycemic Control, Depressive Symptoms, and Renal Function in Low-Income, Minority Patients With Type 2 Diabetes: Results of the Community Approach to Lifestyle Modification for Diabetes Randomized Controlled Trial

    PubMed Central

    Moncrieft, Ashley E.; Llabre, Maria M.; McCalla, Judith Rey; Gutt, Miriam; Mendez, Armando J.; Gellman, Marc D.; Goldberg, Ronald B.; Schneiderman, Neil

    2016-01-01

    ABSTRACT Objective Few interventions have combined life-style and psychosocial approaches in the context of Type 2 diabetes management. The purpose of this study was to determine the effect of a multicomponent behavioral intervention on weight, glycemic control, renal function, and depressive symptoms in a sample of overweight/obese adults with Type 2 diabetes and marked depressive symptoms. Methods A sample of 111 adults with Type 2 diabetes were randomly assigned to a 1-year intervention (n = 57) or usual care (n = 54) in a parallel groups design. Primary outcomes included weight, glycosylated hemoglobin, and Beck Depression Inventory II score. Estimated glomerular filtration rate served as a secondary outcome. All measures were assessed at baseline and 6 and 12 months after randomization by assessors blind to randomization. Latent growth modeling was used to examine intervention effects on each outcome. Results The intervention resulted in decreased weight (mean [M] = 0.322 kg, standard error [SE] = 0.124 kg, p = .010) and glycosylated hemoglobin (M = 0.066%, SE = 0.028%, p = .017), and Beck Depression Inventory II scores (M = 1.009, SE = 0.226, p < .001), and improved estimated glomerular filtration rate (M = 0.742 ml·min−1·1.73 m−2, SE = 0.318 ml·min−1·1.73 m−2, p = .020) each month during the first 6 months relative to usual care. Conclusions Multicomponent behavioral interventions targeting weight loss and depressive symptoms as well as diet and physical activity are efficacious in the management of Type 2 diabetes. Trial Registration: This study is registered at Clinicaltrials.gov ID: NCT01739205. PMID:27359176

  8. Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes

    PubMed Central

    Blozis, Shelley A; Young, Heather M; Nesbitt, Thomas S; Quinn, Charlene C

    2015-01-01

    Background Type 2 diabetes mellitus is a worldwide challenge. Practice guidelines promote structured self-monitoring of blood glucose (SMBG) for informing health care providers about glycemic control and providing patient feedback to increase knowledge, self-efficacy, and behavior change. Paired glucose testing—pairs of glucose results obtained before and after a meal or physical activity—is a method of structured SMBG. However, frequent access to glucose data to interpret values and recommend actions is challenging. A complete feedback loop—data collection and interpretation combined with feedback to modify treatment—has been associated with improved outcomes, yet there remains limited integration of SMBG feedback in diabetes management. Incorporating telehealth remote monitoring and asynchronous electronic health record (EHR) feedback from certified diabetes educators (CDEs)—specialists in glucose pattern management—employ the complete feedback loop to improve outcomes. Objective The purpose of this study was to evaluate a telehealth remote monitoring intervention using paired glucose testing and asynchronous data analysis in adults with type 2 diabetes. The primary aim was change in glycated hemoglobin (A1c)—a measure of overall glucose management—between groups after 6 months. The secondary aims were change in self-reported Summary of Diabetes Self-Care Activities (SDSCA), Diabetes Empowerment Scale, and Diabetes Knowledge Test. Methods A 2-group randomized clinical trial was conducted comparing usual care to telehealth remote monitoring with paired glucose testing and asynchronous virtual visits. Participants were aged 30-70 years, not using insulin with A1c levels between 7.5% and 10.9% (58-96 mmol/mol). The telehealth remote monitoring tablet computer transmitted glucose data and facilitated a complete feedback loop to educate participants, analyze actionable glucose data, and provide feedback. Data from paired glucose testing were analyzed

  9. First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--Executive summary.

    PubMed

    Hering, Bernhard J; Cozzi, Emanuele; Spizzo, Thomas; Cowan, Peter J; Rayat, Gina R; Cooper, David K C; Denner, Joachim

    2016-01-01

    The International Xenotransplantation Association has updated its original "Consensus Statement on Conditions for Undertaking Clinical Trials of Porcine Islet Products in Type 1 Diabetes," which was published in Xenotransplantation in 2009. This update is timely and important in light of scientific progress and changes in the regulatory framework pertinent to islet xenotransplantation. Except for the chapter on "informed consent," which has remained relevant in its 2009 version, all other chapters included in the initial consensus statement have been revised for inclusion in this update. These chapters will not provide complete revisions of the original chapters; rather, they restate the key points made in 2009, emphasize new and under-appreciated topics not fully addressed in 2009, suggest relevant revisions, and communicate opinions that complement the consensus opinion. Chapter 1 provides an update on national regulatory frameworks addressing xenotransplantation. Chapter 2 a, previously Chapter 2, suggests several important revisions regarding the generation of suitable source pigs from the perspective of the prevention of xenozoonoses. The newly added Chapter 2b discusses conditions for the use of genetically modified source pigs in clinical islet xenotransplantation. Chapter 3 reviews porcine islet product manufacturing and release testing. Chapter 4 revisits the critically important topic of preclinical efficacy and safety data required to justify a clinical trial. The main achievements in the field of transmission of all porcine microorganisms, the rationale for more proportionate recipient monitoring, and response plans are reviewed in Chapter 5. Patient selection criteria and circumstances where trials of islet xenotransplantation would be both medically and ethically justified are examined in Chapter 6 in the context of recent advances in available and emerging alternative therapies for serious and potentially life-threatening complications of diabetes

  10. Effects of a combined strengthening, stretching and functional training program versus usual-care on gait biomechanics and foot function for diabetic neuropathy: a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Polyneuropathy is a complication of diabetes mellitus that has been very challenging for clinicians. It results in high public health costs and has a huge impact on patients' quality of life. Preventive interventions are still the most important approach to avoid plantar ulceration and amputation, which is the most devastating endpoint of the disease. Some therapeutic interventions improve gait quality, confidence, and quality of life; however, there is no evidence yet of an effective physical therapy treatment for recovering musculoskeletal function and foot rollover during gait that could potentially redistribute plantar pressure and reduce the risk of ulcer formation. Methods/Design A randomised, controlled trial, with blind assessment, was designed to study the effect of a physiotherapy intervention on foot rollover during gait, range of motion, muscle strength and function of the foot and ankle, and balance confidence. The main outcome is plantar pressure during foot rollover, and the secondary outcomes are kinetic and kinematic parameters of gait, neuropathy signs and symptoms, foot and ankle range of motion and function, muscle strength, and balance confidence. The intervention is carried out for 12 weeks, twice a week, for 40-60 min each session. The follow-up period is 24 weeks from the baseline condition. Discussion Herein, we present a more comprehensive and specific physiotherapy approach for foot and ankle function, by choosing simple tasks, focusing on recovering range of motion, strength, and functionality of the joints most impaired by diabetic polyneuropathy. In addition, this intervention aims to transfer these peripheral gains to the functional and more complex task of foot rollover during gait, in order to reduce risk of ulceration. If it shows any benefit, this protocol can be used in clinical practice and can be indicated as complementary treatment for this disease. Trial Registration ClinicalTrials.gov Identifier: NCT01207284 PMID

  11. Reduced viscosity Barley β-Glucan versus placebo: a randomized controlled trial of the effects on insulin sensitivity for individuals at risk for diabetes mellitus

    PubMed Central

    2011-01-01

    Background Prior studies suggest soluble fibers may favorably affect glucose/insulin metabolism. Methods This prospective, randomized, placebo controlled, double blind, parallel group trial evaluated 50 generally healthy subjects without prior diagnosis of diabetes mellitus (44 completers), who were administered beverages containing placebo (control), lower dose (3 g/d), or higher dose (6 g/d) reduced viscosity barley β-glucan (BBG) extract. Subjects (68% women) mean age 56 years, Body Mass Index (BMI) 32 kg/m2 and baseline fasting plasma glucose 102 mg/dl were instructed to follow a weight-maintaining Therapeutic Lifestyle Changes (TLC) diet and consumed three 11 oz study beverages daily with meals for 12 weeks. The four primary study endpoint measures were plasma glucose and insulin [each fasting and post-Oral Glucose Tolerance Testing (OGTT)]. Results Compared to placebo, administration of 3 g/d BBG over 12 weeks significantly reduced glucose incremental Area Under the Curve (iAUC) measures during OGTT and 6 g/d BBG over 12 weeks significantly reduced fasting insulin as well as the related homeostasis model assessment of insulin resistance (HOMA-IR). Beverages were generally well tolerated with no serious adverse experiences and no significant differences between groups for adverse experiences. Per protocol instruction, subjects maintained body weight. Conclusions These findings suggest 6 g/d BBG consumed in a beverage over 12 weeks may improve insulin sensitivity among hyperglycemic individuals with no prior diagnosis of diabetes mellitus, and who experience no change in body weight. Trial Registration ClinicalTrials.gov Identifier: NCT01375803. PMID:21846371

  12. Sodium glucose co-transporter 2 inhibitors for glycemic control in type 2 diabetes mellitus: Quality of reporting of randomized controlled trials

    PubMed Central

    Mittal, Niti; Mittal, Rakesh; Kumar, Harish; Medhi, Bikash

    2016-01-01

    Background: Sodium glucose co-transporter 2 inhibitors represent a novel class of antidiabetic drugs. The reporting quality of the trials evaluating the efficacy of these agents for glycemic control in type 2 diabetes mellitus has not been explored. Our aim was to assess the reporting quality of such randomized controlled trials (RCTs) and to identify the predictors of reporting quality. Materials and Methods: A systematic literature search was conducted for RCTs published till 12 June 2014. Two independent investigators carried out the searches and assessed the reporting quality on three parameters: Overall quality score (OQS) using Consolidated Standards of Reporting Trials (CONSORT) 2010 statement, Jadad score and intention to treat analysis. Inter-rater agreements were compared using Cohen's weighted kappa statistic. Multivariable linear regression analysis was used to identify the predictors. Results: Thirty-seven relevant RCTs were included in the present analysis. The median OQS was 17 with a range from 8 to 21. On Jadad scale, the median score was three with a range from 0 to 5. Complete details about allocation concealment and blinding were present in 21 and 10 studies respectively. Most studies lacked an elaborate discussion on trial limitations and generalizability. Among the factors identified as significantly associated with reporting quality were the publishing journal and region of conduct of RCT. Conclusions: The key methodological items remain poorly reported in most studies. Strategies like stricter adherence to CONSORT guidelines by journals, access to full trial protocols to gain valuable information and full collaboration among investigators and methodologists might prove helpful in improving the quality of published RCT reports. PMID:26955572

  13. Comparison of a mindful eating intervention to a diabetes self-management intervention among adults with type 2 diabetes: a randomized controlled trial.

    PubMed

    Miller, Carla K; Kristeller, Jean L; Headings, Amy; Nagaraja, Haikady

    2014-04-01

    Mindful eating may be an effective intervention for increasing awareness of hunger and satiety cues, improving eating regulation and dietary patterns, reducing symptoms of depression and anxiety, and promoting weight loss. Diabetes self-management education (DSME), which addresses knowledge, self-efficacy, and outcome expectations for improving food choices, also may be an effective intervention for diabetes self-care. Yet few studies have compared the impact of mindful eating to a DSME-based treatment approach on patient outcomes. Adults 35 to 65 years old with type 2 diabetes for ≥1 year not requiring insulin therapy were recruited from the community and randomly assigned to treatment group. The impact of a group-based 3-month mindful eating intervention (MB-EAT-D; n = 27) to a group-based 3-month DSME "Smart Choices" (SC) intervention (n = 25) postintervention and at 3-month follow-up was evaluated. Repeated-measures ANOVA with contrast analysis compared change in outcomes across time. There was no significant difference between groups in weight change. Significant improvement in depressive symptoms, outcome expectations, nutrition and eating-related self-efficacy, and cognitive control and disinhibition of control regarding eating behaviors occurred for both groups (all p < .0125) at 3-month follow-up. The SC group had greater increase in nutrition knowledge and self-efficacy than the MB-EAT-D group (all p < .05) at 3-month follow-up. MB-EAT-D had significant increase in mindfulness, whereas the SC group had significant increase in fruit and vegetable consumption at study end (all p < .0125). Both SC and MB-EAT-D were effective treatments for diabetes self-management. The availability of mindful eating and DSME-based approaches offers patients greater choices in meeting their self-care needs. PMID:23855018

  14. Phosphodiesterase-5 inhibitors for erectile dysfunction in patients with diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials

    PubMed Central

    Balhara, Yatan Pal Singh; Sarkar, Siddharth; Gupta, Rishab

    2015-01-01

    Background and Aims: Patients with diabetes mellitus frequently experience erectile dysfunction. This systematic review and meta-analysis were conducted to find efficacy and tolerability of phosphodiesterase 5 (PDE5) inhibitors in patients with diabetes mellitus experiencing erectile dysfunction. Methodology: Electronic searches were carried out to identify English language peer-reviewed randomized controlled trials (RCTs), which reported clinical efficacy of any PDE5 inhibitor in patients with diabetes mellitus having erectile dysfunction. Effect sizes were computed using Cohen's d, and I2-test was used to assess heterogeneity. Pooled mean effect sizes were computed using random-effects model. Number needed to treat (NNT), and the adverse event rates were computed. Results: The systematic review included a total of 17 studies yielding 25 comparisons. Three studies were open RCTs while others were double-blind RCTs. The pooled mean effect size of any PDE5 inhibitor over placebo was 0.926 (95% confidence intervals [CI]: 0.864-0.987; I2 =26.3). The pooled mean effect size for sildenafil was 1.198 (CI: 1.039-1.357; I2 =0), for tadalafil was 0.910 (CI: 0.838-0.981; I2 =33.6), and for vardenafil was 0.678 (CI: 0.627-0.729; I2 =0). In pooled analysis, the NNT for sildenafil, tadalafil, vardenafil and any PDE5 inhibitor was 2.4, 2.6, 4.1 and 3.0 respectively. The most common side effects were headache, flushing, and nasal congestion. Conclusions: PDE5 inhibitors are effective and safe medications for the treatment of sexual dysfunction in patients with diabetes mellitus experiencing erectile dysfunction. PMID:26180759

  15. Efficacy and safety of linagliptin monotherapy in Asian patients with inadequately controlled type 2 diabetes mellitus: A multinational, 24-week, randomized, clinical trial

    PubMed Central

    Chen, Yuhong; Ning, Guang; Wang, Changjiang; Gong, Yan; Patel, Sanjay; Zhang, Candice; Izumoto, Toshiyasu; Woerle, Hans-Juergen; Wang, Weiqing

    2015-01-01

    Aims/Introduction Asian patients represent a large portion of the global population with type 2 diabetes mellitus, but are underrepresented in trials of glucose-lowering therapies. The present randomized, phase III, placebo-controlled, double-blind, 24-week study evaluated the dipeptidyl peptidase-4 inhibitor, linagliptin, as monotherapy in Asian patients with inadequately controlled type 2 diabetes mellitus. Materials and Methods Patients who were treatment naïve or had been treated with one oral antidiabetes drug were randomized to either linagliptin 5 mg daily or a placebo after washout. The primary end-point was a change from baseline in glycated hemoglobin after 24 weeks. Results A total of 300 Asian (87% Chinese) patients with type 2 diabetes mellitus were randomized to linagliptin or placebo at a 2:1 ratio. After 24 weeks of treatment, adjusted mean (standard error) glycated hemoglobin decreased by a placebo-corrected −0.50 ± 0.11 (P < 0.0001). In patients with baseline glycated hemoglobin ≥8.5%, the placebo-corrected decrease in glycated hemoglobin was −0.91 ± 0.20% (P < 0.0001). Adverse events occurred in 28.0 and 28.3% of linagliptin and placebo patients, respectively, but few were drug-related (3.0 and 2.0%, respectively). Hypoglycemia was reported by one linagliptin patient and no placebo patients. Treatment with linagliptin was weight neutral. Conclusions In Asian patients with inadequately controlled type 2 diabetes mellitus, linagliptin 5 mg as monotherapy was efficacious and well tolerated over 24 weeks. PMID:26543544

  16. Effects of Satureja khuzestanica on Serum Glucose, Lipids and Markers of Oxidative Stress in Patients with Type 2 Diabetes Mellitus: A Double-Blind Randomized Controlled Trial

    PubMed Central

    Vosough-Ghanbari, Sanaz; Rahimi, Roja; Kharabaf, Shabnam; Zeinali, Shima; Mohammadirad, Azadeh; Amini, Somayeh; Yasa, Nargues; Salehnia, Alinazar; Toliat, Tayebeh; Nikfar, Shekoufeh; Larijani, Bagher

    2010-01-01

    Satureja khuzestanica is an endemic plant of Iran that is widely distributed in the Southern part of the country. It has antioxidant properties and thus it seems to be useful in diseases related to oxidative stress such as diabetes and hyperlipidemia. The present study investigates the effect of S. khuzestanica supplement in metabolic parameters of hyperlipidemic patients with type 2 diabetes mellitus. Twenty-one hyperlipidemic patients with type 2 diabetes mellitus were randomized in a double blind, placebo controlled clinical trial to receive either S. khuzestanica (tablets contain 250 mg dried leaves) or placebo once a day for 60 days. Blood samples were obtained at baseline and at the end of the study. Samples were analyzed for levels of glucose, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, creatinine, thiobarbituric acid reactive substances (TBARS) as marker of lipid peroxidation and ferric reducing ability (total antioxidant power, TAP). Treatment of patients by S. khuzestanica for 60 days induced significant decrease in total cholesterol (P = 0.008) and LDL-cholesterol (P = 0.03) while increased HDL-cholesterol (P = 0.02) and TAP (P = 0.007) in comparison with the baseline values. S. khuzestanica did not alter blood glucose, triglyceride, creatinin and TBARS levels. In comparison with baseline values, no significant change was observed in blood glucose, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, creatinine, TBARS and TAP in placebo-treated group. Usage of S. khuzestanica as a supplement to drug regimen of diabetic type 2 patients with hyperlipidemia is recommended. PMID:18955324

  17. Prospective association of a genetic risk score and lifestyle intervention with cardiovascular morbidity and mortality among individuals with type 2 diabetes: the Look AHEAD randomised controlled trial

    PubMed Central

    2015-01-01

    Aims/hypothesis Both obesity and genetics contribute to cardiovascular disease (CVD). We examined whether a genetic risk score (GRS) prospectively predicted cardiovascular morbidity and mortality among overweight/obese individuals with type 2 diabetes and whether behavioural weight loss could diminish this association. Methods Look AHEAD (Action for Health in Diabetes) is a randomised controlled trial to determine the effects of intensive lifestyle intervention (ILI), including weight loss and physical activity, relative to diabetes support and education, on cardiovascular outcomes among overweight/obese individuals with type 2 diabetes. Of the participants, 4,016 provided consent for genetic analyses and had DNA samples passing quality control procedures. These secondary data analyses focused on whether a GRS derived from 153 single nucleotide polymorphisms (SNPs) associated with coronary artery disease in the most recent genome-wide association study predicted cardiovascular morbidity and mortality over a median of 9.6 years of follow-up, and whether ILI would diminish this association. Results The GRS significantly predicted the primary composite endpoint of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalisation for angina in the full sample (HR, 95% CI per 1 SD increase in GRS: 1.19 [1.10, 1.28]) and among individuals with no known history of CVD at baseline (HR 1.18 [95% CI 1.07, 1.30]). In no case did ILI significantly alter this association. Conclusions/interpretation A GRS comprised of SNPs significantly predicts cardiovascular morbidity and mortality over 9.6 years of follow-up in Look AHEAD. Lifestyle intervention did not alter the genetic association. PMID:25972230

  18. DIABETES PREVENTION PROGRAM

    EPA Science Inventory

    The Diabetes Prevention Program (DPP) was a major clinical trial, or research study, aimed at discovering whether either diet and exercise or the oral diabetes drug metformin (Glucophage) could prevent or delay the onset of type 2 diabetes in people with impaired glucose toleranc...

  19. Diabetes Dyslipidemia.

    PubMed

    Schofield, Jonathan D; Liu, Yifen; Rao-Balakrishna, Prasanna; Malik, Rayaz A; Soran, Handrean

    2016-06-01

    Diabetes mellitus is associated with a considerably increased risk of premature atherosclerotic cardiovascular disease. Intensive glycemic control has essentially failed to significantly improve cardiovascular outcomes in clinical trials. Dyslipidemia is common in diabetes and there is strong evidence that cholesterol lowering improves cardiovascular outcomes, even in patients with apparently unremarkable lipid profiles. Here, the authors review the pathophysiology and implications of the alterations in lipoproteins observed in both type 1 and type 2 diabetes, the effect of medications commonly used in the management of diabetes on the lipid profile, the evidence for lifestyle and pharmaceutical interventions, and national and international recommendations for the management of dyslipidemia in patients with diabetes. PMID:27056202

  20. Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol

    PubMed Central

    2012-01-01

    Background Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps). Methods/Design This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and

  1. Effect of communicating genetic and phenotypic risk for type 2 diabetes in combination with lifestyle advice on objectively measured physical activity: protocol of a randomised controlled trial

    PubMed Central

    2012-01-01

    Background Type 2 diabetes (T2D) is associated with increased risk of morbidity and premature mortality. Among those at high risk, incidence can be halved through healthy changes in behaviour. Information about genetic and phenotypic risk of T2D is now widely available. Whether such information motivates behaviour change is unknown. We aim to assess the effects of communicating genetic and phenotypic risk of T2D on risk-reducing health behaviours, anxiety, and other cognitive and emotional theory-based antecedents of behaviour change. Methods In a parallel group, open randomised controlled trial, approximately 580 adults born between 1950 and 1975 will be recruited from the on-going population-based, observational Fenland Study (Cambridgeshire, UK). Eligible participants will have undergone clinical, anthropometric, and psychosocial measurements, been genotyped for 23 single-nucleotide polymorphisms associated with T2D, and worn a combined heart rate monitor and accelerometer (Actiheart®) continuously for six days and nights to assess physical activity. Participants are randomised to receive either standard lifestyle advice alone (control group), or in combination with a genetic or a phenotypic risk estimate for T2D (intervention groups). The primary outcome is objectively measured physical activity. Secondary outcomes include self-reported diet, self-reported weight, intention to be physically active and to engage in a healthy diet, anxiety, diabetes-related worry, self-rated health, and other cognitive and emotional outcomes. Follow-up occurs eight weeks post-intervention. Values at follow-up, adjusted for baseline, will be compared between randomised groups. Discussion This study will provide much needed evidence on the effects of providing information about the genetic and phenotypic risk of T2D. Importantly, it will be among the first to examine the impact of genetic risk information using a randomised controlled trial design, a population-based sample, and

  2. Assessment of the Reporting Quality of Randomized Controlled Trials on the Treatment of Diabetes Mellitus with Traditional Chinese Medicine: A Systematic Review

    PubMed Central

    Wang, Ping; Xu, Qin; Sun, Qi; Fan, Fang-fang; Guo, Xue-rui; Guo, Fei

    2013-01-01

    Background After the publication of the CONSORT 2010 statement, few studies have been conducted to assess the reporting quality of randomized clinical trials (RCTs) on treatment of diabetes mellitus with Traditional Chinese Medicine (TCM) published in Chinese journals. Objective To investigate the current situation of the reporting quality of RCTs in leading medical journals in China with the CONSORT 2010 statement as criteria. Methods The China National Knowledge Infrastructure (CNKI) electronic database was searched for RCTs on the treatment of diabetes mellitus with TCM published in the Journal of Traditional Chinese Medicine, Chinese Journal of Integrated Traditional & Western Medicine, and the China Journal of Chinese Materia Medica from January to December 2011. We excluded trials reported as “animal studies”, “in vitro studies”, “case studies”, or “systematic reviews”. The CONSORT checklist was applied by two independent raters to evaluate the reporting quality of all eligible trials after discussing and comprehending the items thoroughly. Each item in the checklist was graded as either “yes” or “no” depending on whether it had been reported by the authors. Results We identified 27 RCTs. According to the 37 items in the CONSORT checklist, the average reporting percentage was 45.0%, in which the average reporting percentage for the “title and abstract”, the “introduction”, the “methods”, the “results”, the “discussion” and the “other information” was 33.3%, 88.9%, 36.4%, 54.4%, 71.6% and 14.8%, respectively. In the Journal of Traditional Chinese Medicine, Chinese Journal of Integrated Traditional & Western Medicine, and the China Journal of Chinese Materia Medica the average reporting percentage was 42.2%, 56.8%, and 46.0%, respectively. Conclusions The reporting quality of RCTs in these three journals was insufficient to allow readers to assess the validity of the trials. We recommend that editors require

  3. Effects of probiotics in patients with diabetes mellitus type 2: study protocol for a randomized, double-blind, placebo-controlled trial

    PubMed Central

    2013-01-01

    Background Low grade chronic inflammation is observed in patients with type 2 diabetes mellitus (T2DM). Endotoxin derived from gut bacteria may act as a potent inflammatory stimulant. Probiotics, which are believed to contain health promoting live microorganisms, may influence circulating endotoxin levels. Ingestion of live probiotic cultures may alter gut microbiota in a beneficial manner to reduce inflammation; no information is available whether or not they do so in patients with T2DM. Therefore, the aim of this study is to characterize the beneficial effects of probiotics on circulating endotoxin levels and other biomarkers related to systemic low-grade inflammation in patients with T2DM. Methods One hundred and twenty consenting adult Saudi T2DM patients (naïve or newly diagnosed and without co-morbidities) will be enrolled in this clinical trial and randomized to receive daily placebo or probiotics (Ecologic®Barrier) for 26 weeks in a double-blind manner. Inflammatory and metabolic markers will be measured and fecal samples analyzed. Measurements/samples will be obtained at baseline and after 4, 8, 12/13 and 26 weeks of treatment. Discussion It is expected that the probiotic product will induce beneficial changes in gut microbiota, reduce the systemic inflammatory state through altering systemic endotoxin levels and, as such, reduce the systemic inflammatory response observed in T2DM subjects. Trial registration ClinicalTrials.gov Identifier: NCT01765517 PMID:23822518

  4. Information Communication Technology (ICT) Shaping Student Affairs.

    ERIC Educational Resources Information Center

    Broughton, Elizabeth

    This paper opens with the following questions: "How prepared are you as a student affairs professional for information communication technology (ICT)? Do you understand such concepts as portals, e-business, Napster, computer use policies, and wireless communication? Will student affairs be shaped by ICT or will student affairs help shape ICT on…

  5. A GUIDE TO UNDERSTANDING WORLD AFFAIRS.

    ERIC Educational Resources Information Center

    ROGERS, WILLIAM C.

    WRITTEN IN EVERYDAY ENGLISH, THIS READING BOOK PRESENTS MANY FACTS AND IDEAS ABOUT WORLD AFFAIRS. CHAPTERS COVER INTERNATIONAL LIFE, POWER IN WORLD AFFAIRS, WAR AS INTERNATIONAL CONFLICT, THE MEANS AND VARIETIES OF ARMED CONFLICT, INTERNATIONAL CONFLICT SHORT OF WAR, THE ACCOMMODATION OF CONFLICT IN WORLD AFFAIRS, AND PEACE--WHAT IT IS AND HOW TO…

  6. The harms of smoking and benefits of smoking cessation in women compared with men with type 2 diabetes: an observational analysis of the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron modified release Controlled Evaluation) trial

    PubMed Central

    Blomster, Juuso I; Woodward, Mark; Zoungas, Sophia; Hillis, Graham S; Harrap, Stephen; Neal, Bruce; Poulter, Neil; Mancia, Giuseppe; Chalmers, John; Huxley, Rachel

    2016-01-01

    Objectives In general populations, the adverse effects of smoking on coronary risk have been demonstrated to be greater in women than in men; whether this is true for individuals with diabetes is unclear. Design Cohort study. Setting 20 countries worldwide participating in the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron modified release Controlled Evaluation) trial. Participants 11 140 patients with type 2 diabetes aged ≥55 years and in cardiovascular risk at the time of randomisation. Primary and secondary outcome measures Major cardiovascular events (death from cardiovascular disease, non-fatal stroke or non-fatal myocardial infarction (MI)), all cardiovascular events (major cardiovascular event or peripheral arterial disease or transient ischaemic attack), and all-cause mortality. Secondary outcome measures were major coronary events (fatal and non-fatal MI), major cerebrovascular events (fatal and non-fatal stroke), nephropathy (new or worsening renal disease), and all cancer. Results At baseline, 6466 (56% women) participants were never-smokers, 1550 (28% women) were daily smokers and 3124 (21% women) were former smokers. Median follow-up time was 5 years. In Cox regression models after multiple adjustments, compared with never smoking, daily smoking was associated with increased risk of all primary and secondary outcomes with the exception of major cerebrovascular disease. Only for major coronary events was there any evidence of a stronger effect in women than in men (ratio of the adjusted HRs women:men; 1.64 (0.83 to 3.26) p=0.08). For all other outcomes considered, the hazards of smoking were similar in men and women. Quitting smoking was associated with a 30% reduction in all-cause mortality (p=0.001) in both sexes. Conclusions In individuals with diabetes, the effects of smoking on all major forms of cardiovascular disease are equally as hazardous in women and men with the possible exception of major coronary events

  7. A randomised controlled trial evaluating the impact of targeted vitamin D supplementation on endothelial function in type 2 diabetes mellitus: The DIMENSION trial

    PubMed Central

    Dalan, Rinkoo; Liew, Huiling; Assam, Pryseley Nkouibert; Chan, Edwin SY; Siddiqui, Fahad Javaid; Tan, Alvin WK; Chew, Daniel EK; Boehm, Bernhard O; Leow, Melvin KS

    2016-01-01

    We sought to determine if vitamin D supplementation, to target 25(OH)D concentrations of 30–40 ng/mL, improves endothelial function in Singapore’s multi-ethnic type 2 diabetes mellitus population. We randomised 64 type 2 diabetes mellitus patients with hypovitaminosis D to cholecalciferol 4000 International Unit/matching placebo [baseline 25(OH)D < 20 ng/mL] or cholecalciferol 2000 International Unit/matching placebo [baseline 25(OH)D: 20–30 ng/mL] daily for 16 weeks with a down titration at 8 weeks if 25(OH)D > 30 ng/mL. Endothelial function was assessed by peripheral tonometry (reactive hyperaemia index–endothelial peripheral arterial tonometry) and vascular biomarkers: E-selectin, von-Willebrand factor and high-sensitivity C-reactive protein. We compared the change from baseline parameters in the two groups using Student’s t-test or Kruskal–Wallis test. A log-normal multivariate regression analysis was used to adjust for relevant baseline variables. The median reactive hyperaemia index in the vitamin D group increased from 0.65 (interquartile range: 0.42) to 0.73 (interquartile range: 0.36), whereas it decreased from 0.73 (interquartile range: 0.65) to 0.65 (interquartile range: 0.38) (p = 0.02) in the placebo group. After adjustment for baseline variables, the change was not statistically significant for reactive hyperaemia index (p = 0.07) and for other vascular biomarkers (p > 0.05). Targeted vitamin D supplementation for 16 weeks resulted in a small but non-significant improvement in endothelial function in a type 2 diabetes mellitus cohort. PMID:26818228

  8. Diabetes Technologies and Their Role in Diabetes Management

    ERIC Educational Resources Information Center

    Kollipara, Sobha; Silverstein, Janet H.; Marschilok, Katie

    2009-01-01

    The 1993 Diabetes Complications and Control Trial (DCCT) showed that controlling blood glucose prevents and delays the progression of long term complications of diabetes. New diabetes technologies can make control of diabetes possible and safer. This paper reviews these technologies used to monitor blood glucose, administer insulin and evaluate…

  9. Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial

    PubMed Central

    Griffin, Simon J; Borch-Johnsen, Knut; Davies, Melanie J; Khunti, Kamlesh; Rutten, Guy EHM; Sandbæk, Annelli; Sharp, Stephen J; Simmons, Rebecca K; van den Donk, Maureen; Wareham, Nicholas J; Lauritzen, Torsten

    2011-01-01

    Summary Background Intensive treatment of multiple cardiovascular risk factors can halve mortality among people with established type 2 diabetes. We investigated the effect of early multifactorial treatment after diagnosis by screening. Methods In a pragmatic, cluster-randomised, parallel-group trial done in Denmark, the Netherlands, and the UK, 343 general practices were randomly assigned screening of registered patients aged 40–69 years without known diabetes followed by routine care of diabetes or screening followed by intensive treatment of multiple risk factors. The primary endpoint was first cardiovascular event, including cardiovascular mortality and morbidity, revascularisation, and non-traumatic amputation within 5 years. Patients and staff assessing outcomes were unaware of the practice's study group assignment. Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00237549. Findings Primary endpoint data were available for 3055 (99·9%) of 3057 screen-detected patients. The mean age was 60·3 (SD 6·9) years and the mean duration of follow-up was 5·3 (SD 1·6) years. Improvements in cardiovascular risk factors (HbA1c and cholesterol concentrations and blood pressure) were slightly but significantly better in the intensive treatment group. The incidence of first cardiovascular event was 7·2% (13·5 per 1000 person-years) in the intensive treatment group and 8·5% (15·9 per 1000 person-years) in the routine care group (hazard ratio 0·83, 95% CI 0·65–1·05), and of all-cause mortality 6·2% (11·6 per 1000 person-years) and 6·7% (12·5 per 1000 person-years; 0·91, 0·69–1·21), respectively. Interpretation An intervention to promote early intensive management of patients with type 2 diabetes was associated with a small, non-significant reduction in the incidence of cardiovascular events and death. Funding National Health Service Denmark, Danish Council for Strategic Research, Danish Research

  10. An updated review of long-term outcomes from randomized controlled trials in approved pharmaceuticals for diabetic macular edema.

    PubMed

    Wang, Jia-Kang; Huang, Tzu-Lun; Su, Pei-Yuan; Chang, Pei-Yao

    2015-12-01

    Diabetic macular edema (DME) is a major sight-threatening cause in diabetic patients. We review the long-term outcome of four approved pharmacotherapy for treating DME, including intravitreal injections of corticosteroids (dexamethasone implants and fluocinolone acetonide inserts) and anti-vascular endothelial growth factor (VEGF) (ranibizumab and aflibercept). They all show superior ability to improve vision and reduce macular thickness, comparing with sham injections or macular focal/grid laser treatment. Anti-VEGF agents result in low incidence of severe ocular or systemic adverse effects, but glaucoma and cataract should be aware after intravitreal corticosteroids. Prompt treatment with these agents can lead to a better outcome PMID:27215008

  11. Effects of strengthening, stretching and functional training on foot function in patients with diabetic neuropathy: results of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Foot musculoskeletal deficits are seldom addressed by preventive medicine despite their high prevalence in patients with diabetic polyneuropathy. AIM: To investigate the effects of strengthening, stretching, and functional training on foot rollover process during gait. Methods A two-arm parallel-group randomized controlled trial with a blinded assessor was designed. Fifty-five patients diagnosed with diabetic polyneuropathy, 45 to 65 years-old were recruited. Exercises for foot-ankle and gait training were administered twice a week, for 12 weeks, to 26 patients assigned to the intervention group, while 29 patients assigned to control group received recommended standard medical care: pharmacological treatment for diabetes and foot care instructions. Both groups were assessed after 12 weeks, and the intervention group at follow-up (24 weeks). Primary outcomes involved foot rollover changes during gait, including peak pressure (PP). Secondary outcomes involved time-to-peak pressure (TPP) and pressure–time integral (PTI) in six foot-areas, mean center of pressure (COP) velocity, ankle kinematics and kinetics in the sagittal plane, intrinsic and extrinsic muscle function, and functional tests of foot and ankle. Results Even though the intervention group primary outcome (PP) showed a not statistically significant change under the six foot areas, intention-to-treat comparisons yielded softening of heel strike (delayed heel TPP, p=.03), better eccentric control of forefoot contact (decrease in ankle extensor moment, p<.01; increase in function of ankle dorsiflexion, p<.05), earlier lateral forefoot contact with respect to medial forefoot (TPP anticipation, p<.01), and increased participation of hallux (increased PP and PTI, p=.03) and toes (increase in PTI, medium effect size). A slower COP mean velocity (p=.05), and an increase in overall foot and ankle function (p<.05) were also observed. In most cases, the values returned to baseline after the follow-up (p

  12. Efficacy of pre-exercise low-level laser therapy on isokinetic muscle performance in individuals with type 2 diabetes mellitus: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Type 2 diabetes, also known non-insulin-dependent diabetes, is the most prevalent type of the disease and involves defects in the secretion and action of insulin. The aim of the proposed study is to evaluate the efficacy of pre-exercise low-level laser therapy (LLLT) on muscle performance of the quadriceps femoris in individuals with type 2 diabetes. Methods/Design A double-blind, randomized, controlled clinical trial will be carried out in two treatment phases. In the first phase, quadriceps muscle performance will be evaluated using an isokinetic dynamometer and the levels of creatine kinase and lactate dehydrogenase (biochemical markers of muscle damage) will be determined. The participants will then be allocated to four LLLT groups through a randomization process using opaque envelopes: Group A (4 Joules), Group B (6 Joules), Group C (8 Joules) and Group D (0 Joules; placebo). Following the administration of LLLT, the participants will be submitted to an isokinetic eccentric muscle fatigue protocol involving the quadriceps muscle bilaterally. Muscle performance and biochemical markers of muscle damage will be evaluated again immediately after as well as 24 and 48 hours after the experimental protocol. One week after the last evaluation the second phase will begin, during which Groups A, B and C will receive the LLLT protocol that achieved the best muscle performance in phase 1 for a period of 4 weeks. At the end of this period, muscle performance will be evaluated again. The protocol for this study is registered with the World Health Organization under Universal Trial Number U1111-1146-7109. Discussion The purpose of this randomized clinical trial is to evaluate the efficacy of pre-exercise LLLT on the performance of the quadriceps muscle (peak torque, total muscle work, maximum power and fatigue index – normalized by body mass) in individuals with DM-2. The study will support the practice of evidence-based to the use of LLLT in improving muscle

  13. Effect of JYTK on Antioxidant Status and Inflammation in Patients With Type 2 Diabetes: A Randomized Double-Blind Clinical Trial

    PubMed Central

    Hu, Yuan; Zhou, Xin; Guo, Dai-Hong; Liu, Ping

    2016-01-01

    Background Diabetes is a metabolic disorder caused by oxidative stress and inflammation. JianYuTangKang (JYTK), as a potential Chinese integrative medicine, is an antioxidant used in Chinese medicine with potential anti-inflammatory properties. Objectives The present randomized clinical trial was carried out to evaluate the effects of JYTK on oxidative stress and inflammation in patients with type 2 diabetes mellitus (T2DM). Patients and Methods The parallel, randomized, double-blinded, placebo-controlled clinical trial included 150 newly diagnosed T2DM patients receiving metformin treatment (1.5 g/day), some of whom also received JYTK (4.5 g/day) in tablet form. The control group received 4.5 g/day placebo plus 1.5 g/day metformin. Body mass index (BMI), fasting plasma glucose, urinary albumin-to-creatinine ratio, and complete blood count as well as antioxidant and inflammation indices such as tumor necrosis factor (TNF)-α, interleukin (IL)-6, superoxide dismutase (SOD), malonaldehyde (MDA), glutathione peroxidase (GPX), and high sensitivity C-reactive protein (hs-CRP) levels were assessed at baseline and at different time points during the treatment. Results All 112 patients, including 59 in the treatment group (JYTK + metformin) and 52 controls (metformin only) completed the 26-week clinical trial. JYKT plus metformin treatment increased IL-6 (36.4 ± 11.5 ng/L; P < 0.05), TNF-α (17.5 ± 11.3 vs. 22.5 ± 12.9 ng/L; P < 0.05), and MDA (1.9 ± 0.9; P < 0.05) levels compared to the control (2.2 ± 0.6 mM/mL), whereas total SOD level decreased (98.1 ± 30.4 vs. 78.5 ± 29.3 U/mL; P < 0.05). There were no changes in GPX and hs-CRP levels. There were no adverse effects associated with JYTK treatment. Conclusions JYTK combined with metformin improves some antioxidant indices (SOD and MDA), and decreases inflammation in patients with T2DM, suggesting that it can reduce the risk of diabetic complications. PMID:27279835

  14. LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial

    PubMed Central

    Petrie, John R.; Marso, Steven P.; Bain, Stephen C.; Franek, Edward; Jacob, Stephan; Masmiquel, Luis; Leiter, Lawrence A.; Haluzik, Martin; Satman, Ilhan; Omar, Mohamed; Shestakova, Marina; Van Gaal, Luc; Mann, Johannes F.; Baeres, Florian M.M.; Zinman, Bernard; Poulter, Neil R.

    2016-01-01

    Objective: As glucagon-like peptide-1 receptor agonists lower blood pressure (BP) in type 2 diabetes mellitus (T2DM), we examined BP control in relation to targets set by international bodies prior to randomization in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial. Methods: We analyzed baseline data from LEADER (NCT01179048), an ongoing phase 3B, randomized, double-blind, placebo-controlled cardiovascular outcomes trial examining the cardiovascular safety of the glucagon-like peptide-1 receptor agonist liraglutide in 9340 people with T2DM from 32 countries [age (all mean ± SD) 64 ± 7.2 years, BMI 32.5 ± 6.3 kg/m2, duration of diabetes 12.7 ± 8.0 years], all of whom were at high risk for cardiovascular disease (CVD). Results: A total of 81% (n = 7592) of participants had prior CVD and 90% (n = 8408) had a prior history of hypertension. Despite prescription of multiple antihypertensive agents at baseline, only 51% were treated to a target BP of less than 140/85 mmHg and only 26% to the recommended baseline BP target of less than 130/80 mmHg. In univariate analyses, those with prior CVD were prescribed more agents (P < 0.001) and had lower BP than those without (137 ± 18.8/78 ± 10.6 mmHg versus 140 ± 17.7/80 ± 9.9 mmHg; P < 0.001). In logistic regression analyses, residency in North America (64% treated to <140/85 mmHg; 38% treated to <130/80 mmHg) was the strongest predictor of BP control. Conclusion: These contemporary data confirm that BP remains insufficiently controlled in a large proportion of individuals with T2DM at high cardiovascular risk, particularly outside North America. Longitudinal data from the LEADER trial may provide further insights into BP control in relation to cardiovascular outcomes in this condition. PMID:26855018

  15. Sleeve gastrectomy versus Roux-en-Y gastric bypass for type 2 diabetes and morbid obesity: double-blind randomised clinical trial protocol

    PubMed Central

    Murphy, Rinki; Evennett, Nicholas J; Clarke, Michael G; Robinson, Steven J; Humphreys, Lee; Jones, Bronwen; Kim, David D; Cutfield, Richard; Plank, Lindsay D; Hammodat, Hisham; Booth, Michael W C

    2016-01-01

    Introduction Type 2 diabetes (T2D) in association with obesity is an increasing disease burden. Bariatric surgery is the only effective therapy for achieving remission of T2D among those with morbid obesity. It is unclear which of the two most commonly performed types of bariatric surgery, laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), is most effective for obese patients with T2D. The primary objective of this study is to determine whether LSG or LRYGB is more effective in achieving HbA1c<6% (<42 mmol/mol) without the use of diabetes medication at 5 years. Methods and analysis Single-centre, double-blind (assessor and patient), parallel, randomised clinical trial (RCT) conducted in New Zealand, targeting 106 patients. Eligibility criteria include a