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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. Blood Pressure and Cardiovascular Disease Risk in the Veterans Affairs Diabetes Trial

    PubMed Central

    Anderson, Robert J.; Bahn, Gideon D.; Moritz, Thomas E.; Kaufman, Derrick; Abraira, Carlos; Duckworth, William

    2011-01-01

    OBJECTIVE Blood pressure ranges associated with cardiovascular disease (CVD) events in advanced type 2 diabetes are not clear. Our objective was to determine whether baseline and follow-up (On-Study) systolic blood pressure (SBP), diastolic blood pressure (DBP), and SBP combined with DBP predict CVD events in the Veterans Affairs Diabetes Trial (VADT). RESEARCH DESIGN AND METHODS Participants in the VADT (n = 1,791) with hypertension received stepped treatment to maintain blood pressure below the target of 130/80 mmHg in standard and intensive glycemic treatment groups. Blood pressure levels of all subjects at baseline and On-Study were analyzed to detect associations with CVD risk. The primary outcome was the time from randomization to the first occurrence of myocardial infarction, stroke, congestive heart failure, surgery for vascular disease, inoperable coronary disease, amputation for ischemic gangrene, or CVD death. RESULTS Separated SBP ≥140 mmHg had significant risk at baseline (hazards ratio [HR] 1.508, P < 0.001) and On-Study (HR 1.469, P = 0.002). DBP <70 mmHg increased CVD events at baseline (HR 1.482, P < 0.001) and On-Study (HR 1.491, P < 0.001). Combined blood pressure categories indicated high risk for CVD events for SBP ≥140 with DBP <70 mmHg at baseline (HR 1.785, P = 0.03) and On-Study (HR 2.042, P = 0.003) and nearly all SBP with DBP <70 mmHg. CONCLUSIONS Increased risk of CVD events with SBP ≥140 mmHg emphasizes the urgency for treatment of systolic hypertension. Increased risk with DBP <70 mmHg, even when combined with SBP in guideline-recommended target ranges, supports a new finding in patients with type 2 diabetes. The results emphasize that DBP <70 mmHg in these patients was associated with elevated CVD risk and may best be avoided. PMID:21059830

  3. [Current controversies in glycemic control targets. What do the results of the latest clinical trials tell us about the approach to type 2 diabetes mellitus?].

    PubMed

    Mauricio, Dídac; Rius, Ferran

    2010-09-01

    The aim of this article is to discuss the implications of the results obtained in the latest large-scale clinical trials designed to evaluate the effect of intensive glycemic control on the vascular complications associated with type 2 diabetes mellitus. The current scientific evidence is reviewed and the implications of the ACCORD (The Action to Control Cardiovascular Risk in Diabetes study group), ADVANCE (Action in Diabetes and Vascular disease: Preterax and Diamicron Modified Release Control Evaluation) and VADT (Veterans Affairs Diabetes Trial) clinical trials are discussed. General concerns of the studies and their implications for clinical practice and the management of type 2 diabetes, as well as the questions which still need to be answered by future clinical research are discussed.

  4. Therapy for couples after an affair: a randomized-controlled trial.

    PubMed

    Kröger, Christoph; Reißner, Timo; Vasterling, Ilka; Schütz, Kristina; Kliem, Sören

    2012-12-01

    To examine the efficacy of a couples treatment approach for promoting recovery from a recently disclosed affair, 89 couples that disclosed an affair by one of the partners in the past 6 months were randomly assigned to treatment (n = 46) or to a control group that waited about 3 months for treatment (n = 43). The couples completed self-report measures (Beck Depression Inventory, Impact of Event Scale-Revised, Partnership Questionnaire) at pre- and post-treatment. Since about half of the couples dropped out for various reasons (e.g., ongoing affair, separation), we used multiple imputations to handle the missing data problem. We analyzed the dyadic data with hierarchical linear modeling in a two-level model. Significant improvements on scores of anxiety corresponded with large effect sizes for both partners. Yet significant improvements on depression scores were only found for the unfaithful partner with moderate effect size. Results suggest that the treatment can improve individual complaints, but not relationship satisfaction in a sufficient amount for both partners. Hence, future research should address how this intervention could encourage couples to maintain therapy, and how they might achieve more and sustained improvement in relationship satisfaction.

  5. Computerized management of diabetes: a synthesis of controlled trials.

    PubMed

    Balas, E A; Boren, S A; Griffing, G

    1998-01-01

    Computerized management of diabetes is the use of information technology to improve diabetic patient outcomes. The computer can be used to provide educational information to patients and facilitate the storage and transmittal of clinical data between patients and clinicians. The objective of this paper was to evaluate computerized management of diabetes in changing the health outcomes. Clinical trial reports were identified through systematic electronic database and manual searches. Four eligibility criteria were applied: diabetes clinical area; prospective, contemporaneously controlled clinical trial with random assignment of the intervention; computer generated information for patients in the intervention group and no similar intervention in the control group; and measurement of effect on the outcome of care (health status, social functioning, patient/family satisfaction). Data were abstracted using a standardized abstraction form and the quality of methodology was scored. Of 15 eligible clinical trials, 12 (80%) reported positive outcomes or significant benefits. A total of 48 outcome measures were reported, an average of 3.2/study. Significantly improved clinical outcomes included Hemoglobin A1c (HbA1c), blood glucose, and hypoglycemic events. Patient-computer interaction appears to be a valuable supplement to interaction with clinicians. Considering the need to enhance patient participation in the care of chronic illnesses, initial evidence indicates computers can play a more significant role in the future.

  6. 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

  7. 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.

  8. Motivational interviewing for modifying diabetes risk: a randomised controlled trial

    PubMed Central

    Greaves, Colin J; Middlebrooke, Andrew; O'Loughlin, Lucy; Holland, Sandra; Piper, Jane; Steele, Anna; Gale, Tracy; Hammerton, Fenella; Daly, Mark

    2008-01-01

    Background Around 10–15% of adults aged over 40 years have pre-diabetes, which carries a high risk of progression to type 2 diabetes. Intensive lifestyle intervention reduces progression by as much as 58%. However, the cost and personnel requirements of these interventions are major obstacles to delivery in NHS primary care. Aim To assess the effectiveness of a low-cost intervention, delivered in primary care by non-NHS staff, to reduce the risk of diabetes through weight loss and physical activity. Design of study Pragmatic single-blind randomised controlled trial with researchers and statistician blinded to group allocation. Setting UK primary care. Method One-hundred and forty-one participants with a body mass index of 28 kg/m2 or more, but without diabetes or heart disease, received either information leaflets or individual behavioural counselling using motivational interviewing techniques. The intervention was delivered by five counsellors recruited from the local community. The primary outcomes were the proportions of participants meeting predefined targets for weight loss (5%) and moderate physical activity (150 minutes/week) after 6 months. Results Using intention-to-treat analysis, more people in the intervention group achieved the weight-loss target (24% versus 7% for controls; odds ratio [OR] = 3.96; 95% confidence interval [Cl] = 1.4 to 11.4; number needed to treat [NNT] = 6.1 (95% Cl = 4 to 21). The proportion achieving the physical activity target did not increase significantly (38% versus 28% for controls; OR = 1.6; 95% Cl = 0.7 to 3.8). Conclusion Short-term weight loss, at a level which, if sustained, is clinically meaningful for reducing diabetes risk, is achievable in primary care, without excessive use of NHS monetary or personnel resources. PMID:18682011

  9. Promoting good clinical practices in the conduct of clinical trials: experiences in the Department of Veterans Affairs Cooperative Studies Program.

    PubMed

    Sather, Mike R; Raisch, Dennis W; Haakenson, Clair M; Buckelew, Julia M; Feussner, John R

    2003-10-01

    The ever-increasing concern for the welfare of volunteers participating in clinical trials and for the integrity of the data derived from those trials has generated the concept of Good Clinical Practice (GCP). The Veterans Affairs Cooperative Studies Program, in anticipation of the need to comply with GCP guidelines, developed a Site Monitoring and Review Team (SMART), which consists of a Good Clinical Practice Monitoring Group and a Good Clinical Practice Review Group. The review group conducted 335 site reviews from fiscal years (FY) 1999 through 2001 to assess and encourage adherence to GCP. Data from reviews were compared for two time periods, a 2-year implementation period (FYs 1999/2000, n=204) and a continuing follow-up period (FY 2001, n=131). Overall, high GCP adherence was exhibited by 11.3% (n=23) of study sites in FY 1999/2000 versus 20.6% (n=27) in FY 2001, average to good adherence was exhibited by 84.3% (n=172) in FY 1999/2000 versus 77.0% (n=101) in FY 2001, and below average adherence was exhibited by 4.4% (n=9) versus 1.5% (n=3) in these two periods. These changes were statistically significant by chi square analysis (p=0.029). Moreover, GCP adherence was assessed within eight GCP focus areas: patient informed consent, protocol adherence, safety monitoring, institutional review board interactions, regulatory document management, patient records in investigator file, drug/device accountability, and general site operations. Median assessment scores for all 62 GCP review elements improved from 0.82 to 0.89 (p<0.001). Median assessment scores for the 14 selected critical GCP items improved from 0.78 to 0.89 (p<0.001). Median scores for five of the eight GCP focus areas improved significantly (p<0.001) between the two time periods. These data suggest that the site-oriented activities of SMART combined with centralized quality assurance activities of the coordinating centers represent an integrated, versatile program to promote and assure GCP adherence

  10. Diabetes Prevention in Hispanics: Report From a Randomized Controlled Trial

    PubMed Central

    Carosso, Elizabeth; Mariscal, Norma; Islas, Ilda; Ibarra, Genoveva; Holte, Sarah; Copeland, Wade; Linde, Sandra; Thompson, Beti

    2014-01-01

    Introduction Hispanics are at increased risk of developing type 2 diabetes. Lifestyle interventions are effective in preventing diabetes and restoring glucose regulation. Methods We recruited Hispanic men and women (N = 320) who were residents of the Lower Yakima Valley, Washington, aged 18 years or older with hemoglobin A1c (HbA1c) levels higher than 6% to a parallel 2-arm randomized-controlled trial conducted from 2008 through 2012. The trial compared participants in the intervention arm, who received an immediate educational curriculum (n = 166), to participants in the control arm, who received a delayed educational curriculum (n = 154). The home-based curriculum consisted of 5 sessions led by community health workers and was designed to inform participants about diabetes, diabetes treatment, and healthy dietary and physical activity behaviors. Participants were randomly assigned to the intervention and control arms, and analysts were blinded as to participant arm. We evaluated intervention effects on HbA1c levels; frequency (times per week) of fruit and vegetable consumption; and frequency (times per week) of mild, moderate, and strenuous leisure-time physical activity. At baseline, 3 months, and 6 months after randomization, participants completed a questionnaire and provided a blood sample. Analysts were blinded to intervention arm. Results The immediate intervention group (−0.64% [standard error (SE) 0.10]) showed a significant improvement in HbA1c scores (–37.5%, P = .04) compared with the delayed intervention group (–0.44%, P = .14). No significant changes were seen for dietary end points or changes in physical activity. We did observe a trend of greater increases in frequency of moderate and vigorous physical activity and a smaller increase in mild physical activity in the immediate intervention group than in the delayed intervention group. Conclusion This home-based intervention delivered by CHWs was associated with a clinically and statistically

  11. 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

  12. Current progress of human trials using stem cell therapy as a treatment for diabetes mellitus

    PubMed Central

    Cheng, Shuk Kei; Park, Elisse Y; Pehar, Andjela; Rooney, Alexandra C; Gallicano, G. Ian

    2016-01-01

    Diabetes mellitus affects millions of people worldwide, and is associated with serious complications that affect nearly all body systems. Because of the severity of this global health concern, there is a great deal of research being performed on alternative treatments and possible cures. Previous treatments for diabetes have included exogenous insulin injection and pancreatic islet transplantations. These treatment methods have several limitations; thus, the use of stem cells in treating diabetes is currently a significant area of research. This review outlines current research on stem cell therapy for diabetes mellitus. Numerous studies have been performed on animals using various types of stem cells, including mesenchymal stem cells and embryonic stem cells. Moreover, results and limitations of animal studies have been confirmed in various clinical trials. Overall, stem cell treatment shows prospective advantages over insulin injections and other current treatment options, and ongoing clinical trials suggest that this therapy may be a viable treatment option for diabetics in the near future. PMID:27853629

  13. Neuropathy and related findings in the diabetes control and complications trial/epidemiology of diabetes interventions and complications study.

    PubMed

    Martin, Catherine L; Albers, James W; Pop-Busui, Rodica

    2014-01-01

    OBJECTIVE To describe the development and progression of neuropathy and related findings among patients with type 1 diabetes who participated in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study. RESEARCH DESIGN AND METHODS The main diabetic peripheral neuropathy (DPN) outcome was assessed using clinical symptoms, signs, and nerve conduction study results during DCCT and repeated in EDIC year 13/14. Cardiovascular autonomic neuropathy (CAN) was assessed by R-R response to paced breathing, Valsalva ratio, and blood pressure response to standing during DCCT and in EDIC years 13/14 and 16/17. Additionally, symptoms reflecting neuropathic pain and autonomic function (including hypoglycemia awareness) were collected yearly in EDIC using standardized questionnaires; peripheral neuropathy was also assessed annually using the Michigan Neuropathy Screening Instrument. Assessments of genitourinary function were collected at EDIC year 10. RESULTS Intensive therapy during the DCCT significantly reduced the risk of DPN and CAN at DCCT closeout (64% and 45%, respectively, P < 0.01). The prevalence and incidence of DPN and CAN remained significantly lower in the DCCT intensive therapy group compared with the DCCT conventional therapy group through EDIC year 13/14. CONCLUSIONS The persistent effects of prior intensive therapy on neuropathy measures through 14 years of EDIC largely mirror those observed for other diabetes complications. DCCT/EDIC provides important information on the influence of glycemic control, and the clinical course of diabetic neuropathy, and, most important, on how to prevent neuropathy in type 1 diabetes.

  14. 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.

  15. Translating Findings from Lifestyle Intervention Trials of Cardiovascular Disease and Diabetes to the Primary Care Setting

    PubMed Central

    Palacios, Cristina

    2017-01-01

    Preventing or delaying type 2 diabetes and cardiovascular disease is a key public health issue. Large, randomized, clinical trials have shown that intensive lifestyle interventions can be used to prevent or delay type 2 diabetes and to improve cardiovascular disease risk factors, but the key question that remains is how to best translate the results from these large, clinical trials into interventions that can be effectively delivered in primary care and community-based settings. Several effective approaches have been identified and tested. New research examining specific physical activity or dietary behaviors also has identified new behavioral targets for interventions.

  16. 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

  17. Methodology for conduct of epidemiologic surveys and randomized controlled trials of diabetic polyneuropathy.

    PubMed

    Dyck, Peter James

    2014-01-01

    This chapter outlines: (1) the reasons why epidemiologic surveys and randomized controlled clinical trials (RCTs) of diabetic polyneuropathy (DPN) are difficult and expensive, and often poorly done, (2) primary and secondary neuropathy end points, (3) single versus composite neuropathic end points, (4) adequate reference values from study of population representative cohorts, and (5) the issue of clinical proficiency.

  18. Methylenetetrahydrofolate reductase (MTHFR) polymorphism A1298C (Glu429Ala) predicts decline in renal function over time in the African-American Study of Kidney Disease and Hypertension (AASK) Trial and Veterans Affairs Hypertension Cohort (VAHC)

    PubMed Central

    Salem, Rany M.; Lipkowitz, Michael S.; Bhatnagar, Vibha; Pandey, Braj; Schork, Nicholas J.; O’Connor, Daniel T.

    2012-01-01

    Background. Hyperhomocysteinemia is associated with increased venous thrombosis and cardiovascular disease (CVD). Mutations in the human methylenetetrahydrofolate reductase (MTHFR) gene have been associated with increased homocysteine levels and risks of CVD in various populations including those with kidney disease. Here, we evaluated the influence of MTHFR variants on progressive loss of kidney function. Methods. We analyzed 821 subjects with hypertensive nephrosclerosis from the longitudinal National Institute of Diabetes and Digestive and Kidney Diseases African-American Study of Kidney Disease and Hypertension (AASK) Trial to determine whether decline in glomerular filtration rate (GFR) over ∼4.2 years was predicted by common genetic variation within MTHFR at non-synonymous positions C677T (Ala222Val) and A1298C (Glu429Ala) or by MTHFR haplotypes. The effect on GFR decline was then supported by a study of 1333 subjects from the San Diego Veterans Affairs Hypertension Cohort (VAHC), followed over ∼4.5 years. Linear effect models were utilized to determine both genotype [single-nucleotide polymorphism (SNP)] and genotype (SNP)-by-time interactions. Results. In AASK, the polymorphism at A1298C predicted the rate of GFR decline: A1298/A1298 major allele homozygosity resulted in a less pronounced decline of GFR, with a significant SNP-by-time interaction. An independent follow-up study in the San Diego VAHC subjects supports that A1298/A1298 homozygotes have the greatest estimated GFR throughout the study. Haplotype analysis with C677T yielded concurring results. Conclusion. We conclude that the MTHFR-coding polymorphism at A1298C is associated with renal decline in African-Americans with hypertensive nephrosclerosis and is supported by a veteran cohort with a primary care diagnosis of hypertension. Further investigation is needed to confirm such findings and to determine what molecular mechanism may contribute to this association. PMID:21613384

  19. Problem-solving therapy for adults with diabetic retinopathy and diabetes-specific distress: a pilot randomized controlled trial

    PubMed Central

    Rees, Gwyneth; O'Hare, Fleur; Saeed, Marian; Sudholz, Bronwyn; Sturrock, Bonnie A; Xie, Jing; Speight, Jane; Lamoureux, Ecosse L

    2017-01-01

    Objective To provide preliminary evidence for the impact of problem-solving therapy for diabetes (PST-D) in adults with diabetic retinopathy (DR) and diabetes distress. Research design and methods In a pilot randomized controlled trial, 40 participants with DR and diabetes distress were allocated to the PST-D or control groups. Diabetes distress (DDS), depressive symptoms (PHQ-9), self-care activities (SDSCA), and HbA1c were assessed at baseline, and 3 and 6-month follow-ups. Results At the 6-month follow-up, the PST-D group showed significant improvements relative to the control group, in ‘regimen-related distress’ (PST-D: −1.3±1.4; control: −0.4±1.1), depressive symptoms (PST-D: −4.3±6.1; control: −0.3±4.6), and HbA1c (PST-D: −1.2%±1.01; control: 0.2%±1.2%) (all p<0.05). In multiple regression analysis, adjusting for baseline values and sociodemographic factors, PST-D was associated with significant improvement in ‘regimen-related distress’, depressive symptoms, and HbA1c at the 6-month follow-up (p<0.05). Conclusions PST-D is a promising intervention for improving psychological outcomes and glycemic control. A fully powered study is required to confirm these findings and examine mechanisms of change in HbA1c. Trial registration number ACTRN12616001010482; results. PMID:28243448

  20. 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

  1. The development, validation, and utility of the Diabetes Prevention Trial-Type 1 Risk Score (DPTRS).

    PubMed

    Sosenko, Jay M; Skyler, Jay S; Palmer, Jerry P

    2015-08-01

    This report details the development, validation, and utility of the Diabetes Prevention Trial-Type 1 (DPT-1) Risk Score (DPTRS) for type 1 diabetes (T1D). Proportional hazards regression was used to develop the DPTRS model which includes the glucose and C-peptide sums from oral glucose tolerance tests at 30, 60, 90, and 120 min, the log fasting C-peptide, age, and the log BMI. The DPTRS was externally validated in the TrialNet Natural History Study cohort (TNNHS). In a study of the application of the DPTRS, the findings showed that it could be used to identify normoglycemic individuals who were at a similar risk for T1D as those with dysglycemia. The DPTRS could also be used to identify lower risk dysglycemic individuals. Risk estimates of individuals deemed to be at higher risk according to DPTRS values did not differ significantly between the DPT-1 and the TNNHS; whereas, the risk estimates for those with dysglycemia were significantly higher in DPT-1. Individuals with very high DPTRS values were found to be at such marked risk for T1D that they could reasonably be considered to be in a pre-diabetic state. The findings indicate that the DPTRS has utility in T1D prevention trials and for identifying pre-diabetic individuals.

  2. Behavioral health coaching for rural veterans with diabetes and depression: a patient randomized effectiveness implementation trial

    PubMed Central

    2014-01-01

    Background Depression and diabetes cause significant burden for patients and the healthcare system and, when co-occurring, result in poorer self-care behaviors and worse glycemic control than for either condition alone. However, the clinical management of these comorbid conditions is complicated by a host of patient, provider, and system-level barriers that are especially problematic for patients in rural locations. Patient-centered medical homes provide an opportunity to integrate mental and physical health care to address the multifaceted needs of complex comorbid conditions. Presently, there is a need to not only develop robust clinical interventions for complex medically ill patients but also to find feasible ways to embed these interventions into the frontlines of existing primary care practices. Methods/design This randomized controlled trial uses a hybrid effectiveness-implementation design to evaluate the Healthy Outcomes through Patient Empowerment (HOPE) intervention, which seeks to simultaneously address diabetes and depression for rural veterans in Southeast Texas. A total of 242 Veterans with uncontrolled diabetes and comorbid symptoms of depression will be recruited and randomized to either the HOPE intervention or to a usual-care arm. Participants will be evaluated on a host of diabetes and depression-related measures at baseline and 6- and 12-month follow-up. The trial has two primary goals: 1) to examine the effectiveness of the intervention on both physical (diabetes) and emotional health (depression) outcomes and 2) to simultaneously pilot test a multifaceted implementation strategy designed to increase fidelity and utilization of the intervention by coaches interfacing within the primary care setting. Discussion This ongoing blended effectiveness-implementation design holds the potential to advance the science and practice of caring for complex medically ill patients within the constraints of a busy patient-centered medical home. Trial

  3. Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods.

    PubMed

    Buse, John B; Bigger, J Thomas; Byington, Robert P; Cooper, Lawton S; Cushman, William C; Friedewald, William T; Genuth, Saul; Gerstein, Hertzel C; Ginsberg, Henry N; Goff, David C; Grimm, Richard H; Margolis, Karen L; Probstfield, Jeffrey L; Simons-Morton, Denise G; Sullivan, Mark D

    2007-06-18

    Most patients with type 2 diabetes mellitus develop cardiovascular disease (CVD), with substantial loss of life expectancy. Nonfatal CVD contributes greatly to excess healthcare costs and decreased quality of life in patients with diabetes. The current epidemic of obesity has raised expectations that CVD associated with type 2 diabetes will become an even greater public health challenge. Despite the importance of this health problem, there is a lack of definitive data on the effects of the intensive control of glycemia and other CVD risk factors on CVD event rates in patients with type 2 diabetes. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial is a randomized, multicenter, double 2 x 2 factorial design study involving 10,251 middle-aged and older participants with type 2 diabetes who are at high risk for CVD events because of existing CVD or additional risk factors. ACCORD is testing the effects of 3 medical treatment strategies to reduce CVD morbidity and mortality. All participants are in the glycemia trial, which is testing the hypothesis that a therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level of <6.0% will reduce the rate of CVD events more than a strategy that targets an HbA1c level of 7.0%-7.9%. The lipid trial includes 5,518 of the participants, who receive either fenofibrate or placebo in a double-masked fashion to test the hypothesis of whether, in the context of good glycemic control, a therapeutic strategy that uses a fibrate to increase high-density lipoprotein cholesterol and lower triglyceride levels together with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) to lower low-density lipoprotein cholesterol will reduce the rate of CVD events compared with a strategy that uses a statin plus a placebo. The blood pressure trial includes the remaining 4,733 participants and tests the hypothesis that a therapeutic strategy that targets a systolic blood pressure of <120 mm Hg in the context

  4. Educational video game for juvenile diabetes: results of a controlled trial.

    PubMed

    Brown, S J; Lieberman, D A; Germeny, B A; Fan, Y C; Wilson, D M; Pasta, D J

    1997-01-01

    Packy & Marlon, an interactive video game designed to improve self-care among children and adolescents with diabetes, was evaluated in a six-month randomized controlled trial. In the game, players take the role of animated characters who manage their diabetes by monitoring blood glucose, taking insulin injections, and choosing foods, while setting out to save a diabetes summer camp from marauding rats and mice who have stolen the diabetes supplies. Study participants were patients aged 8 to 16 from two separate diabetes clinics. Each participant received a Super Nintendo video game system at an initial clinic visit and was randomly assigned to receive either Packy & Marlon (treatment group, N = 31) or an entertainment video game containing no diabetes-related content (control group, N = 28). Participants were interviewed and a parent filled out a questionnaire at baseline, three months, and six months. The findings in this study indicate that well-designed, educational video games can be effective interventions. There was improvement in the treatment group relative to the control group in terms of diabetes-related self-efficacy (p = 0.07), communication with parents about diabetes (p = 0.025), and self-care behaviours (p = 0.003), and a decrease in unscheduled urgent doctor visits (p = 0.08). There were no significant differences between the groups in knowledge about diabetes or in glycated haemoglobin (HbA1c) levels. Since participants in the study were in general well-controlled patients who were receiving excellent medical care, future research is contemplated involving youngsters who are not under good glycaemic control.

  5. DIABETES

    PubMed Central

    Natarajan, Loki

    2015-01-01

    A new study shows that statin therapy before diagnosis of diabetes mellitus is not associated with an increased risk of microvascular disease and might even be beneficial for retinopathy and neuropathy. These data suggest a potential protective effect of statins in specific complications, which should be further investigated in randomized controlled trials. PMID:25366041

  6. The Diabetes Care Project: an Australian multicentre, cluster randomised controlled trial [study protocol

    PubMed Central

    2013-01-01

    Background Diabetes mellitus is an increasingly prevalent metabolic disorder that is associated with substantial disease burden. Australia has an opportunity to improve ways of caring for the growing number of people with diabetes, but this may require changes to the way care is funded, organised and delivered. To inform how best to care for people with diabetes, and to identify the extent of change that is required to achieve this, the Diabetes Care Project (DCP) will evaluate the impact of two different, evidence-based models of care (compared to usual care) on clinical quality, patient and provider experience, and cost. Methods/Design The DCP uses a pragmatic, cluster randomised controlled trial design. Accredited general practices that are situated within any of the seven Australian Medicare Locals/Divisions of General Practice that have agreed to take part in the study were invited to participate. Consenting practices will be randomly assigned to one of three treatment groups for approximately 18 to 22 months: (a) control group (usual care); (b) Intervention 1 (which tests improvements that could be made within the current funding model, facilitated through the use of an online chronic disease management network); or (c) Intervention 2 (which includes the same components as Intervention 1, as well as altered funding to support voluntary patient registration with their practice, incentive payments and a care facilitator). Adult patients who attend the enrolled practices and have established (≥12 month’s duration) type 1 diabetes mellitus or newly diagnosed or established type 2 diabetes mellitus are invited to participate. Multiple outcomes will be studied, including changes in glycosylated haemoglobin (primary outcome), changes in other biochemical and clinical metrics, incidence of diabetes-related complications, quality of life, clinical depression, success of tailored care, patient and practitioner satisfaction, and budget sustainability. Discussion

  7. 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

  8. Use of the Diabetes Medication Choice Decision Aid in patients with type 2 diabetes in Greece: a cluster randomised trial

    PubMed Central

    Karagiannis, Thomas; Liakos, Aris; Branda, Megan E; Athanasiadou, Eleni; Mainou, Maria; Boura, Panagiota; Goulis, Dimitrios G; LeBlanc, Annie; Montori, Victor M

    2016-01-01

    Objective To assess the efficacy of the Diabetes Medication Choice Decision Aid among patients with type 2 diabetes in Greece. Design Open-label cluster randomised controlled trial. Setting Primary and secondary care practices across Greece. Participants 5 sites allocated to the decision aid (n=101 patients) and 4 sites to control (n=103 patients). Intervention Clinicians and patients in the intervention arm used a decision aid, based on outcomes that both consider important when choosing among antihyperglycaemic medications. Patients in the control arm received usual care. Outcome measures The primary outcome was patient's level of decisional comfort after the initial clinical encounter. Secondary outcomes included patient's knowledge about type 2 diabetes and medications, and patient's and clinician's satisfaction. Adherence to prescribed antihyperglycaemic medication and change in glycated haemoglobin were assessed at 24 weeks. Results Patients in both arms had similar scores in overall decisional comfort (mean difference between the usual care and decision aid arms −6.9, 95% CI −21.5 to 7.7) and its subscales. Patients' knowledge was high in both arms (mean difference 2.3%, 95% CI −15.7% to 20.4%). Patients and clinicians in both groups were equally satisfied with the decision-making. No significant difference in medication adherence and glycaemic control was found across arms. Clinicians found the decision aid useful and reported that its integration in their daily routine was easy. Conclusions The decision aid was implemented and positively received in the clinical setting in Greece, in line with the patient-centred approach endorsed by current guidelines. However, this trial yielded imprecise results in terms of patient outcomes. Further research is needed to investigate the interaction between the patient and the clinician in order to clarify the association between the use of decision aids and implementation of shared decision-making. Trial

  9. Assessing the Collective Population Representativeness of Related Type 2 Diabetes Trials by Combining Public Data from ClinicalTrials.gov and NHANES.

    PubMed

    He, Zhe; Wang, Shuang; Borhanian, Elhaam; Weng, Chunhua

    2015-01-01

    Randomized controlled trials generate high-quality medical evidence. However, the use of unjustified inclusion/exclusion criteria may compromise the external validity of a study. We have introduced a method to assess the population representativeness of related clinical trials using electronic health record (EHR) data. As EHR data may not perfectly represent the real-world patient population, in this work, we further validated the method and its results using the National Health and Nutrition Examination Survey (NHANES) data. We visualized and quantified the differences in the distributions of age, HbA1c, and BMI among the target population of Type 2 diabetes trials, diabetics in NHANES databases, and a convenience sample of patients enrolled in selected Type 2 diabetes trials. The results are consistent with the previous study.

  10. Public Affairs

    DTIC Science & Technology

    2007-11-02

    military assistance to civil authorities ( MACA ), including consequence management activities. The Armed Forces of the United States support the NSHS...mission and the close relationship between HD and homeland security, homeland defense missions may be conducted in a manner similar to MACA (i.e., with a...during a major event. 4. Public Affairs Operations Under the National Response Plan a. The NRP outlines the federal (including DOD MACA ) response to

  11. Rationale and design of the Early Sleeve gastrectomy In New Onset Diabetic Obese Patients (ESINODOP) trial.

    PubMed

    Trastulli, Stefano; Desiderio, Jacopo; Grandone, Ilenia; Fontana, Lucia; Paolini, Luisa; Altomare, Maria; D'Angelo, Paola; Palazzi, Mariangela; Cirocchi, Roberto; Leotta, Sergio; Fatati, Giuseppe; Parisi, Amilcare

    2017-03-01

    No randomized clinical trials (RCTs) have yet evaluated the bariatric surgery's efficacy and safety in patients newly diagnosed with type 2 diabetes mellitus (T2DM). The aim of this multicenter RCT is to compare bariatric surgery, particularly laparoscopic sleeve gastrectomy (LSG), with conventional medical therapy (CMT) in obese patients (body mass index between 30 and 42 kg/m(2)) newly diagnosed with T2DM and without any diabetes-related complications at any stage. A total of 100 eligible patients will be randomized at a 1:1 ratio to undergo one of the two planned treatments and will be followed for at least 6 years after randomization. The main objective of the ESINODOP trial is to investigate the efficacy of LSG compared with CMT alone in inducing and maintaining a remission of T2DM (defined as HbA1c levels ≤6.0 %, without active pharmacologic therapy after 1 year). The remission of T2DM will also be evaluated with the criteria provided by the American Diabetes Association (ADA), and the additional parameters such as adverse event rates, micro- and macrovascular complications, weight loss, gastrointestinal hormones, and quality of life will be compared. The study started on September 2015 and the planned recruitment period is 3 years. Patient recruitment and follow-up take place in the two diabetology and nutrition centers participating in the study, which are performed on a national basis. The ESINODOP trial is designed with the intent of comparing the efficacy of CMT alone to that of CMT in conjunction with LSG performed at the time of diabetes diagnosis in mildly obese diabetic patients. Currently, patients with these characteristics are not eligible for bariatric/metabolic surgery.

  12. 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

  13. 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

  14. 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…

  15. 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...

  16. 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.

  17. 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

  18. 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

  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. The effect of genetic counseling for adult offspring of patients with type 2 diabetes on attitudes toward diabetes and its heredity: a randomized controlled trial.

    PubMed

    Nishigaki, M; Tokunaga-Nakawatase, Y; Nishida, J; Kazuma, K

    2014-10-01

    The aim of this study is to investigate the effect of diabetes genetic counseling on attitudes toward diabetes and its heredity in relatives of type 2 diabetes patients. This study was an unmasked, randomized controlled trial at a medical check-up center in Japan. Subjects in this study are healthy adults between 30 and 60 years of age who have a family history of type 2 diabetes in their first degree relatives. Participants in the intervention group received a brief genetic counseling session for approximately 10 min. Genetic counseling was structured based on the Health Belief Model. Both intervention and control groups received a booklet for general diabetes prevention. Risk perception and recognition of diabetes, and attitude towards its prevention were measured at baseline, 1 week and 1 year after genetic counseling. Participants who received genetic counseling showed significantly higher recognition about their sense of control over diabetes onset than control group both at 1 week and 1 year after the session. On the other hand, anxiety about diabetes did not change significantly. The findings show that genetic counseling for diabetes at a medical check center helped adults with diabetes family history understand they are able to exert control over the onset of their disease through lifestyle modification.

  1. 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

  2. Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals. Methods/Design The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups. Discussion This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population. Trial registration Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066 PMID:24135085

  3. Comparative Effectiveness of Goal Setting in Diabetes Mellitus Group Clinics:Randomized Clinical Trial

    PubMed Central

    Naik, Aanand D.; Palmer, Nynikka; Petersen, Nancy J.; Street, Richard L.; Rao, Radha; Suarez-Almazor, Maria; Haidet, Paul

    2011-01-01

    Background Diabetes group clinics can effectively control hypertension, but data to support glycemic control is equivocal. This study evaluated the comparative effectiveness of two diabetes group clinic interventions on glycosolated hemoglobin (HbA1c) levels in primary care. Methods Participants (n = 87) were recruited from a diabetes registry of a single regional VA medical center to participate in an open, randomized comparative effectiveness study. Two primary care based diabetes group interventions of three months duration were compared. Empowering Patients in Care (EPIC) was a clinician-led, patient-centered group clinic consisting of four sessions on setting self-management action plans (diet, exercise, home monitoring, medications, etc.) and communicating about progress with action plans. The comparison intervention consisted of group education sessions with a diabetes educator and dietician followed by an additional visit with one’s primary care provider. HbA1c levels were compared post-intervention and at one-year follow-up. Results Participants in the EPIC intervention had significantly greater improvements in HbA1c levels immediately following the active intervention (8.86 to 8.04 vs. 8.74 to 8.70, mean [SD] between-group difference 0.67±1.3, P=.03) and these differences persisted at 1 year follow-up (.59±1.4, P=.05). A repeated measures analysis using all study time points found a significant time-by-treatment interaction effect on HbA1c levels favoring the EPIC intervention (F(2,85) =3.55, P= .03). The effect of the time-by-treatment interaction appears to be partially mediated by diabetes self-efficacy (F(1,85) =10.39, P= .002). Conclusions Primary care based diabetes group clinics that include structured goal-setting approaches to self-management can significantly improve HbA1c levels post-intervention and maintain improvements for 1-year. Trial registration ClinicalTrials.gov Identifier: NCT00481286 PMID:21403042

  4. 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

  5. Using web-based familial risk information for diabetes prevention: a randomized controlled trial

    PubMed Central

    2013-01-01

    Background It has been suggested that family history information may be effective in motivating people to adopt health promoting behaviour. The aim was to determine if diabetic familial risk information by using a web-based tool leads to improved self-reported risk-reducing behaviour among individuals with a diabetic family history, without causing false reassurance among those without a family history. Methods An online sample of 1,174 healthy adults aged 35–65 years with a BMI ≥ 25 was randomized into two groups receiving an online diabetes risk assessment. Both arms received general tailored diabetes prevention information, whilst the intervention arm also received familial risk information after completing a detailed family history questionnaire. Separate analysis was performed for four groups (family history group: 286 control versus 288 intervention group; no family history: 269 control versus 266 intervention group). Primary outcomes were self-reported behavioural outcomes: fat intake, physical activity, and attitudes towards diabetes testing. Secondary outcomes were illness and risk perceptions. Results For individuals at familial risk there was no overall intervention effect on risk-reducing behaviour after three months, except for a decrease in self-reported saturated fat intake among low-educated individuals (Beta (b) -1.01, 95% CI −2.01 to 0.00). Familial risk information resulted in a decrease of diabetes risk worries (b −0.21, -0.40 to −0.03). For individuals without family history no effect was found on risk-reducing behaviour and perceived risk. A detailed family history assessment resulted in a greater percentage of individuals reporting a familial risk for diabetes compared to a simple enquiry. Conclusions Web-based familial risk information reduced worry related to diabetes risk and decreased saturated fat intake of those at greatest need of preventative care. However, the intervention was not effective for the total study population on

  6. 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

  7. Community Trial of a Faith-Based Lifestyle Intervention to Prevent Diabetes among African-Americans*

    PubMed Central

    Sattin, Richard W.; Williams, Lovoria B.; Dias, James; Garvin, Jane T.; Marion, Lucy; Joshua, Thomas V.; Kriska, Andrea; Kramer, M. Kaye; Narayan, K.M. Venkat

    2015-01-01

    About 75% of African Americans (AAs) ages 20 or older are overweight and nearly 50% are obese, but community-based programs to reduce diabetes risk in AAs are rare. Our objective was to reduce weight and fasting plasma glucose (FPG) and increase physical activity (PA) from baseline to week-12 and to month-12 among overweight AA parishioners through a faith-based adaptation of the Diabetes Prevention Program called Fit Body and Soul (FBAS). We conducted a single-blinded, cluster randomized, community trial in 20 AA churches enrolling 604 AAs, aged 20 to 64 years with BMI ≥ 25 kg/m2 and without diabetes. The church (and their parishioners) was randomized to FBAS or health education (HE). FBAS participants had a significant difference in adjusted weight loss compared with those in HE (2.62 kg vs. 0.50 kg, p=0.001) at 12-weeks and (2.39 kg vs. −0.465 kg, p=0.005) at 12-months and were more likely (13%) than HE participants (3%) to achieve a 7% weight loss (p<0.001) at 12-weeks and a 7% weight loss (19% vs. 8%, p<0.001) at 12-months. There were no significant differences in FPG and PA between arms. Of the 15.2% of participants with baseline pre-diabetes, those in FBAS had, however, a significant decline in FPG (10.93 mg/dl) at 12-weeks compared with the 4.22 mg/dl increase in HE (p=0.017), and these differences became larger at 12-months (FBAS, 12.38 mg/dl decrease; HE, 4.44 mg/dl increase)(p=0.021). Our faith-based adaptation of the DPP led to a significant reduction in weight overall and in FPG among pre-diabetes participants. PMID:26215167

  8. 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

  9. Randomized, controlled trial of glucose-sparing peritoneal dialysis in diabetic patients.

    PubMed

    Li, Philip K T; Culleton, Bruce F; Ariza, Amaury; Do, Jun-Young; Johnson, David W; Sanabria, Mauricio; Shockley, Ty R; Story, Ken; Vatazin, Andrey; Verrelli, Mauro; Yu, Alex W; Bargman, Joanne M

    2013-11-01

    Glucose-containing peritoneal dialysis solutions may exacerbate metabolic abnormalities and increase cardiovascular risk in diabetic patients. Here, we examined whether a low-glucose regimen improves metabolic control in diabetic patients undergoing peritoneal dialysis. Eligible patients were randomly assigned in a 1:1 manner to the control group (dextrose solutions only) or to the low-glucose intervention group (IMPENDIA trial: combination of dextrose-based solution, icodextrin and amino acids; EDEN trial: a different dextrose-based solution, icodextrin and amino acids) and followed for 6 months. Combining both studies, 251 patients were allocated to control (n=127) or intervention (n=124) across 11 countries. The primary endpoint was change in glycated hemoglobin from baseline. Mean glycated hemoglobin at baseline was similar in both groups. In the intention-to-treat population, the mean glycated hemoglobin profile improved in the intervention group but remained unchanged in the control group (0.5% difference between groups; 95% confidence interval, 0.1% to 0.8%; P=0.006). Serum triglyceride, very-low-density lipoprotein, and apolipoprotein B levels also improved in the intervention group. Deaths and serious adverse events, including several related to extracellular fluid volume expansion, increased in the intervention group, however. These data suggest that a low-glucose dialysis regimen improves metabolic indices in diabetic patients receiving peritoneal dialysis but may be associated with an increased risk of extracellular fluid volume expansion. Thus, use of glucose-sparing regimens in peritoneal dialysis patients should be accompanied by close monitoring of fluid volume status.

  10. Shared decision making for patients with type 2 diabetes: a randomized trial in primary care

    PubMed Central

    2013-01-01

    Background Patient-centered diabetes care requires shared decision making (SDM). Decision aids promote SDM, but their efficacy in nonacademic and rural primary care clinics is unclear. Methods We cluster-randomized 10 practices in a concealed fashion to implement either a decision aid (DA) about starting statins or one about choosing antihyperglycemic agents. Each practice served as a control group for another practice implementing the other type of DA. From April 2011 to July 2012, 103 (DA=53) patients with type 2 diabetes participated in the trial. We used patient and clinician surveys administered after the clinical encounter to collect decisional outcomes (patient knowledge and comfort with decision making, patient and clinician satisfaction). Medical records provided data on metabolic control. Pharmacy fill profiles provided data for estimating adherence to therapy. Results Compared to usual care, patients receiving the DA were more likely to report discussing medications (77% vs. 45%, p<.001), were more likely to answer knowledge questions correctly (risk reduction with statins 61% vs. 33%, p=.07; knowledge about options 57% vs. 33%, p=.002) and were more engaged by their clinicians in decision making (50. vs. 28, difference 21.4 (95% CI 6.4, 36.3), p=.01). We found no significant impact on patient satisfaction, medication starts, adherence or clinical outcomes, in part due to limited statistical power. Conclusion DAs improved decisional outcomes without significant effect on clinical outcomes. DAs designed for point-of-care use with type 2 diabetes patients promoted shared decision making in nonacademic and rural primary care practices. Trial Registration NCT01029288 PMID:23927490

  11. 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.

  12. The Look AHEAD Trial: Implications for Lifestyle Intervention in Type 2 Diabetes Mellitus.

    PubMed

    Dutton, Gareth R; Lewis, Cora E

    2015-01-01

    Given the array of adverse health consequences of obesity, including increased risk for type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD), the Look AHEAD trial (N=5145) was conducted to test the hypothesis that an intensive lifestyle intervention (ILI) for weight loss would achieve significantly greater reductions in CVD morbidity and mortality than a control condition of diabetes support and education (DSE) among participants with T2DM. A number of significant and long-term improvements were observed for ILI, including body weight, physical fitness and physical function, glucose control, quality-of-life (QoL), and healthcare costs. However, ILI did not significantly reduce CVD-related morbidity/mortality (i.e., CVD death, non-fatal MI, non-fatal stroke, hospitalized angina) after nearly 10 years of follow-up. There was a suggestion of heterogeneity of response based on the history of prior CVD at baseline (p=0.06). Despite the overall lack of CVD risk reduction, ILI remains important for care of patients with T2DM, particularly when accompanied by medication management. In particular, ILI may be an appealing option for patients wanting to minimize medication intensification. Also, ILI carries with it other potential benefits important to patients (e.g., improvements in physical functioning and QoL). Based on data from other trials, intensive medication management, such as tight glycemic control, is not without potential risks, which should be weighed in making treatment decisions. Future research is needed to determine if results observed in this trial would be replicated among younger patients, those without established T2DM, and/or those with no pre-existing CVD.

  13. 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

  14. Efficacy of a multifactorial strategy for bowel preparation in diabetic patients undergoing colonoscopy: a randomized trial.

    PubMed

    Alvarez-Gonzalez, Marco Antonio; Flores-Le Roux, Juana A; Seoane, Agustin; Pedro-Botet, Juan; Carot, Laura; Fernandez-Clotet, Agnés; Raga, Agnés; Pantaleon, Miguel A; Barranco, Luis; Bory, Felipe; Lorenzo-Zuñiga, Vicente

    2016-11-01

    Background and study aims: Previous studies have reported that diabetes mellitus is an independent risk factor for inadequate bowel preparation. Current guidelines do not recommend a specific preparation for this patient population. The aims of this study were to assess the efficacy, safety, and tolerability of an adapted preparation protocol for colon cleansing in patients with type 2 diabetes mellitus. Patients and methods: This randomized, single-blind, parallel group, superiority trial compared a conventional bowel preparation protocol (CBP) with a diabetes-specific preparation protocol (DSP). The CBP included a low-fiber diet for 3 days followed by a clear liquid diet for 24 hours before colonoscopy. The DSP included a multifactorial strategy combining an educational intervention, a low-fiber diet, and adjustment of blood glucose-lowering agents. All patients received 4 L of a polyethylene glycol solution in a split-dose regimen. The endoscopists were blinded to the preparation protocol. The primary outcome measure was inadequate bowel preparation according to the Boston Bowel Preparation Scale. Secondary outcome measures included hypoglycemic events, tolerability, and acceptability. Results: A total of 150 patients were included in the study (74 CBP and 76 DSP). Both groups were comparable in terms of baseline characteristics. Inadequate bowel cleansing was more frequent following CBP than DSP (20 % vs. 7 %, P = 0.014; risk ratio 3.1, 95 % confidence interval 1.2 - 8). Only CBP and performance status were independently associated with inadequate bowel preparation. Both preparations were equally tolerated and accepted by patients, and side-effects were similar between the groups. Conclusions: A multifactorial strategy for bowel preparation in patients with diabetes undergoing colonoscopy showed a threefold reduction in the rate of inadequate bowel preparation, with no differences in safety and tolerability compared with conventional preparation.

  15. 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

  16. Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial

    PubMed Central

    Wing, R.; Wadden, T. A.; Knowler, W. C.; Lawlor, M.; Evans, M.; Killean, T.; Montez, M.; Espeland, M. A.; Zhang, P.

    2017-01-01

    Summary Objective The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10 years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. Methods The ILI was designed to promote weight loss and increase physical activity. It involved a combination of group plus individual intervention sessions, with decreasing frequency of contact over the 10 years. The intervention incorporated a variety of strategies, including meal replacement products, to improve weight loss outcomes. The costs of intervention delivery were derived from staff surveys of effort and from records of intervention materials from the 16 US academic clinical trial sites. Costs were calculated from the payer perspective and presented in 2012 dollars. Results During the first year, when intervention delivery was most intensive, the annual cost of intervention delivery, averaged (standard deviation) across clinical sites, was $2,864.6 ($513.3) per ILI participant compared with $202.4 ($76.6) per DSE participant. As intervention intensity declined, costs decreased, such that from years 5 to 9 of the trial, the annual cost of intervention was $1,119.8 ($227.7) per ILI participant and $102.9 ($33.0) per DSE participant. Staffing accounted for the majority of costs throughout the trial, with meal replacements and materials to promote adherence accounting for smaller shares. Conclusions The sustained weight losses produced by the Look AHEAD intervention were supported by intervention costs that were within the range of other weight loss programmes. Future work will include an evaluation of the cost‐effectiveness of the ILI and will contain additional follow

  17. Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): trial protocol

    PubMed Central

    Mann, Eleanor; Prevost, A Toby; Griffin, Simon; Kellar, Ian; Sutton, Stephen; Parker, Michael; Sanderson, Simon; Kinmonth, Ann Louise; Marteau, Theresa M

    2009-01-01

    Background Screening invitations have traditionally been brief, providing information only about population benefits. Presenting information about the limited individual benefits and potential harms of screening to inform choice may reduce attendance, particularly in the more socially deprived. At the same time, amongst those who attend, it might increase motivation to change behavior to reduce risks. This trial assesses the impact on attendance and motivation to change behavior of an invitation that facilitates informed choices about participating in diabetes screening in general practice. Three hypotheses are tested: 1. Attendance at screening for diabetes is lower following an informed choice compared with a standard invitation. 2. There is an interaction between the type of invitation and social deprivation: attendance following an informed choice compared with a standard invitation is lower in those who are more rather than less socially deprived. 3. Amongst those who attend for screening, intentions to change behavior to reduce risks of complications in those subsequently diagnosed with diabetes are stronger following an informed choice invitation compared with a standard invitation. Method/Design 1500 people aged 40–69 years without known diabetes but at high risk are identified from four general practice registers in the east of England. 1200 participants are randomized by households to receive one of two invitations to attend for diabetes screening at their general practices. The intervention invitation is designed to facilitate informed choices, and comprises detailed information and a decision aid. A comparison invitation is based on those currently in use. Screening involves a finger-prick blood glucose test. The primary outcome is attendance for diabetes screening. The secondary outcome is intention to change health related behaviors in those attenders diagnosed with diabetes. A sample size of 1200 ensures 90% power to detect a 10% difference in

  18. The ADDITION-Cambridge trial protocol: a cluster – randomised controlled trial of screening for type 2 diabetes and intensive treatment for screen-detected patients

    PubMed Central

    Echouffo-Tcheugui, Justin B; Simmons, Rebecca K; Williams, Kate M; Barling, Roslyn S; Prevost, A Toby; Kinmonth, Ann Louise; Wareham, Nicholas J; Griffin, Simon J

    2009-01-01

    care. It addresses the feasibility of population-based screening for diabetes, as well as the benefits and costs of screening and intensive multifactorial treatment early in the disease trajectory. The intensive treatment algorithm is based on evidence from studies including individuals with clinically diagnosed diabetes and the education materials are informed by psychological theory. ADDITION-Cambridge will provide timely evidence concerning the benefits of early intensive treatment and will inform policy decisions concerning screening for type 2 diabetes. Trial registration Current Controlled trials ISRCTN86769081 PMID:19435491

  19. 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

  20. Treatment of borderline diabetes: controlled trial using carbohydrate restriction and phenformin.

    PubMed Central

    Jarrett, R J; Keen, H; Fuller, J H; McCartney, M

    1977-01-01

    A five-year therapeutic trial of carbohydrate restriction with or without phenformin (50 mg/day) was performed in men with borderline diabetes. The aim of treatment was to diminish the enhanced risk of cardiovascular disease and deterioration of glucose tolerance. Cardiovascular morbidity and mortality were not significantly affected by any form of treatment, alone or in combination. The predominant risk factor for cardiovascular morbidity and mortality and for overall mortality was the initial blood pressure level. The baseline plasma cholesterol concentration significantly predicted the onset of intermittent claudication. One implication of the results is that hypotensive treatment, supplemented when necessary with hypolipidaemic treatment, may be more effective in preventing the progression of arterial disease in people with mild to moderate glucose intolerance than conventional antidiabetic therapy. PMID:336135

  1. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders. Methods/Design This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks

  2. [Selenium supplementation trials for cancer prevention and the subsequent risk of type 2 diabetes mellitus: selenium and vitamin E cancer prevention trial and after].

    PubMed

    Koyama, Hiroshi; Mutakin; Abdulah, Rizky; Yamazaki, Chiho; Kameo, Satomi

    2013-01-01

    The essential trace element selenium has long been considered to exhibit cancer-preventive, antidiabetic and insulin-mimetic properties. However, recent epidemiological studies have indicated that supranutritional selenium intake and high plasma selenium levels are not necessarily preventive against cancer, and are possible risk factors for developing type 2 diabetes mellitus. The results of the SELECT, Selenium and Vitamin E Cancer Prevention Trial, in which it is hypothesized that the supplementations with selenium and/or vitamin E decrease the prostate cancer incidence among healthy men in the U.S., showed that the supplementation did not prevent the development of prostate cancer and that the incidence of newly diagnosed type 2 diabetes mellitus increased among the selenium-supplemented participants. The Nutritional Prevention of Cancer (NPC) trial showed a decreased risk of prostate cancer among participants taking 200 μg of selenium daily for 7.7 years. However, the results of the NPC trial also showed an increased risk of type 2 diabetes mellitus in the participants with plasma selenium levels in the top tertile at the start of the study. Recently, the association of serum selenium with adipocytokines, such as TNF-α, VCAM-1, leptin, FABP-4, and MCP-1, has been observed. Selenoprotein P has been reported to associated with adiponectin, which suggests new roles of selenoprotein P in cellular energy metabolism, possibly leading to the increased risk of type 2 diabetes mellitus and also the development of cancer. Further studies are required to elucidate the relationship between selenium and adipocytokines and the role of selenoprotein P in the development of type 2 diabetes mellitus and cancer at high levels of selenium.

  3. Diabetic Neuropathy

    MedlinePlus

    ... of diabetic neuropathy may become severe enough to cause depression in some patients. × Prognosis The prognosis for diabetic ... of diabetic neuropathy may become severe enough to cause depression in some patients. View Full Prognosis Clinical Trials ...

  4. Protective effect of tartary buckwheat on renal function in type 2 diabetics: a randomized controlled trial

    PubMed Central

    Qiu, Ju; Li, Zaigui; Qin, Yuchang; Yue, Yanfen; Liu, Yanping

    2016-01-01

    Tartary buckwheat (TB) has been reported to be associated with a decreased risk of type 2 diabetes mellitus (T2DM), and T2DM has had a major impact on the development of diabetic kidney disease (DKD). Thus, the hypothesis that a daily intake of TB will improve DKD risk factors, including urinary albumin to creatinine ratio (UACR), urea nitrogen (UN), serum creatinine, and uric acid was tested. In a parallel, randomized, open-label controlled trial, 104 T2DM patients were randomly assigned to a diet control group (systematic diet plans and intensive nutritional education) or a TB intervention group (daily replacement of a portion of staple foods with TB foods). Blood samples and dietary information were collected at baseline and the end of the 4-week study. The primary outcomes were that TB significantly decreased the rela tive changes in UACR (2.43–2.35, logarithmic transformed mg/g creatinine) and UN (5.12–4.91 mmol/L) in the TB intervention group vs the diet control group at 4 weeks (P<0.05), without obvious effect on blood glucose during the 4-week study. In addition, subgroup analyses based on different DKD stages also showed a significant reduction in UACR and UN for the T2DM patients with normoalbuminuria and microalbuminuria (P<0.05). These results support the hypothesis that TB as a replacement of staple food probably alleviates renal dysfunction in T2DM patients. PMID:27920542

  5. Connective Tissue Reflex Massage for Type 2 Diabetic Patients with Peripheral Arterial Disease: Randomized Controlled Trial

    PubMed Central

    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

  6. China Report, Economic Affairs.

    DTIC Science & Technology

    2007-11-02

    This is China Report include Economic Affairs. It contains the issues with different topics on People’s Republic of China: Provincial Affairs, Economic Planning, Economic Management, Finance and Banking, Mineral Resources , Industry, Transportation.

  7. 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

  8. N-terminal-pro-brain natriuretic peptide is decreased in insulin dependent gestational diabetes mellitus: a prospective cohort trial

    PubMed Central

    2011-01-01

    Background N-terminal-pro-brain natriuretic peptide (NT-proBNP) is elevated in gestational hypertension and preeclampsia. This trial aimed to generate data for gestational diabetes mellitus patients, who are at risk to develop these complications. Methods We have measured NT-proBNP in 223 otherwise healthy women between gestational week 24 and 32 referred to the outpatient diabetes unit in a cross-sectional study. Results 88 control subjects, 45 patients with indication for medical nutrition therapy (MNT) alone and 90 patients who required insulin therapy were included. Groups of women were comparable regarding gestational week. Body mass index before pregnancy and at blood draw was significantly higher in subjects with insulin dependent gestational diabetes mellitus compared to MNT controlled gestational diabetes mellitus. NT-proBNP was significantly lower in patients with insulin dependent gestational diabetes mellitus (35 ± 25 pg/ml) compared to controls (53 ± 43 pg/ml, p = 0.012). Conclusions NT-proBNP is within the reference range of normal subjects in women with gestational diabetes mellitus. Differences in body mass index, changes in glomerular filtration rate and haemodynamics may explain lower NT-proBNP concentrations in insulin dependent gestational diabetes mellitus. A false negative interpretation needs to be considered in these women. PMID:21489265

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

    PubMed

    Marx, Nikolaus; 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

    2015-05-01

    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.

  10. 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

  11. 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

  12. 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

  13. 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

  14. Empagliflozin for Type 2 Diabetes Mellitus: An Overview of Phase 3 Clinical Trials.

    PubMed

    Levine, Matthew J

    2016-06-13

    Sodium glucose cotransporter 2 (SGLT2) inhibitors have a unique mechanism of action leading to excretion of glucose in the urine and subsequent lowering of plasma glucose. This mechanism is independent of β-cell function; thus, these agents are effective treatment for type 2 diabetes mellitus (T2DM) at theoretically any disease stage. This class should not confer an additional risk of hypoglycemia (unless combined with insulin or an insulin secretagogue) and has the potential to be combined with other classes of glucose-lowering agents. Empagliflozin is one of three currently approved SGLT2 inhibitors in the United States, and has shown a favorable benefit-risk ratio in phase 3 clinical trials as monotherapy and as add-on to other glucose-lowering therapy in broad patient populations. In addition to its glucose-lowering effects, empagliflozin has been shown to reduce body weight and blood pressure without a compensatory increase in heart rate. Moreover, on top of standard of care, empagliflozin is the first glucose-lowering agent to demonstrate cardiovascular risk reduction in patients at high risk of cardiovascular disease in a prospective outcomes trial: a 14% reduction in risk of the 3-point composite endpoint of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Like other SGLT2 inhibitors, empagliflozin is associated with a higher rate of genital mycotic infections than placebo and has the potential for volume depletion-associated events. This review summarizes the empagliflozin phase 3 clinical trials program and its potential significance in the treatment of patients with T2DM. Evidence from these clinical trials show reductions in glycated hemoglobin (-0.59 to -0.82%) with a low risk of hypoglycemia except when used with insulin or insulin secretagogues, and moderate reductions in body weight (-2.1 to -2.5 kg) and systolic blood pressure (-2.9 to -5.2 mm Hg), thus supporting the use of empagliflozin as monotherapy or in

  15. A Diabetes Self-Management Program: 12-Month Outcome Sustainability From a Nonreinforced Pragmatic Trial

    PubMed Central

    Lorig, Kate; Turner, Ralph M; English, Kathleen; Laurent, Diana D; Greenberg, Jay

    2016-01-01

    Background Diabetes self-management education has been shown to be effective in controlled trials. The 6-week Better Choices, Better Health-Diabetes (BCBH-D) self-management program was also associated with an improvement in health outcomes in a 6-month translation study. Objective The objective of this study was to determine whether a national translation of the BCBH-D self-management program, offered both Web-based and face-to-face, was associated with improvements in health outcomes (including HbA1c) and health behaviors (including recommended medical tests) 1 year after intervention Methods Web-based programs were administered nationally, whereas face-to-face workshops took place in Atlanta, Indianapolis, and St Louis. Self-report questionnaires were either Web-based or administered by mail, at baseline and 1 year, and collected health and health-behavior measures. HbA1c blood samples were collected via mailed kits. A previous 6-month study found statistically significant improvements in 13 of 14 outcome measures, including HbA1c. For this study, paired t test compared baseline with 1-year outcomes. Subgroup analyses determined whether participants with specific conditions improved (high HbA1c, depression, hypoglycemia, nonadherence to medication, no aerobic exercise). The percentage of participants with improvements in effect size of at least 0.4 in at least 1 of the 5 measures was calculated. Results A total of 857 participants with 1-year data (69.7% of baseline participants) demonstrated statistically significant 1-year improvements in 13 of 15 outcome measures; 79.9% (685/857) of participants showed improvements in effect size of 0.4 or greater in at least 1 of the 5 criterial measures. Conclusions Participants had small but significant benefits in multiple measures. Improvements previously noted at 6 months were maintained or amplified at 1 year. PMID:27979790

  16. 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.

  17. Interleukin-1 antagonism moderates the inflammatory state associated with Type 1 diabetes during clinical trials conducted at disease onset.

    PubMed

    Cabrera, Susanne M; Wang, Xujing; Chen, Yi-Guang; Jia, Shuang; Kaldunski, Mary L; Greenbaum, Carla J; Mandrup-Poulsen, Thomas; Hessner, Martin J

    2016-04-01

    It was hypothesized that IL-1 antagonism would preserve β-cell function in new onset Type 1 diabetes (T1D). However, the Anti-Interleukin-1 in Diabetes Action (AIDA) and TrialNet Canakinumab (TN-14) trials failed to show efficacy of IL-1 receptor antagonist (IL-1Ra) or canakinumab, as measured by stimulated C-peptide response. Additional measures are needed to define immune state changes associated with therapeutic responses. Here, we studied these trial participants with plasma-induced transcriptional analysis. In blinded analyses, 70.2% of AIDA and 68.9% of TN-14 participants were correctly called to their treatment arm. While the transcriptional signatures from the two trials were distinct, both therapies achieved varying immunomodulation consistent with IL-1 inhibition. On average, IL-1 antagonism resulted in modest normalization relative to healthy controls. At endpoint, signatures were quantified using a gene ontology-based inflammatory index, and an inverse relationship was observed between measured inflammation and stimulated C-peptide response in IL-1Ra- and canakinumab-treated patients. Cytokine neutralization studies showed that IL-1α and IL-1β additively contribute to the T1D inflammatory state. Finally, analyses of baseline signatures were indicative of later therapeutic response. Despite the absence of clinical efficacy by IL-1 antagonist therapy, transcriptional analysis detected immunomodulation and may yield new insight when applied to other clinical trials.

  18. Ancillary studies in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial: Synergies and opportunities.

    PubMed

    Sobel, Burton E

    2006-06-19

    The definitive power of randomized controlled trials (RCTs) to characterize the efficacy of putative therapeutic approaches cannot be overestimated. Such trials are expensive, and their implementation requires prolonged and intensive commitments by both investigators and subjects. Accordingly, enhancing their value, in a sense increasing the "scientific return on investment," is a laudatory objective. Ancillary studies afford a great opportunity to do so. They permit acquisition of new knowledge, elucidation of cause/consequence relation, and delineation of pathogenetic mechanisms at a much lower cost than would be possible if they were performed independently of the parent RCTs. In addition, their utility is enhanced by internal consistency under the rubric of the parent trial and the presumed external validation of the parent trial. Several ancillary studies undertaken in conjunction with the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial provide cogent examples. They seek to delineate causal connections linking the accelerated coronary disease typical of diabetes with phenomena such as genetic predisposition to altered expression of cytokines and fibrinolytic system proteins, inflammation, procoagulation, insulin-induced impairment of fibrinolysis, insulin resistance, and the response to insulin-sensitizing and insulin-providing treatment strategies.

  19. Metabolic syndrome in Finnish women 7 years after a gestational diabetes prevention trial

    PubMed Central

    Puhkala, Jatta; Raitanen, Jani; Kolu, Päivi; Tuominen, Pipsa; Husu, Pauliina; Luoto, Riitta

    2017-01-01

    Background Risk for developing metabolic syndrome (MeS) after delivery is high among women with gestational diabetes mellitus (GDM), but little is known about development of MeS among women with risk factors for GDM during pregnancy. In the present study, we studied the prevalence of MeS 7 years postpartum among women with GDM risk factors during pregnancy, women with early GDM diagnosis and women without GDM risk factors. We also analysed the early pregnancy risk factors associated with MeS. Methods A Finnish cluster randomised controlled GDM prevention trial was conducted in 2007–2009. The prevalence of MeS according to International Diabetes Federation criteria was determined in the follow-up study 7 years after original trial. Eligible participants (n=289) in 4 study groups (intervention (n=83) and usual care (n=87) with GDM risk factors; early GDM (n=51), and healthy control without GDM risk factors (n=68)) were evaluated for MeS. Binary logistic regression models were used to analyse risk factors associated with MeS. Results 7 years postpartum, the MeS prevalence was 14% (95% CI 8% to 25%) in the intervention group; 15% (CI 8% to 25%) in the usual care group; 50% (CI 35% to 65%) in the early GDM group and 7% (CI 2% to 18%) in the healthy control group. OR for MeS in women with GDM risk factors did not differ from the healthy control group. Body mass index (BMI)-adjusted OR for MeS was 9.18 (CI 1.82 to 46.20) in the early GDM group compared with the healthy control group. Increased prepregnancy BMI was associated with MeS (OR, 1.17, CI 1.08 to 1.28, adjusted for group). Conclusions Increased prepregnancy BMI and early GDM diagnosis were the strongest risk factors for developing MeS 7 years postpartum. Overweight and obese women and especially those with early GDM should be monitored and counselled for cardiometabolic risk factors after delivery. PMID:28298369

  20. Early feeding and risk of type 1 diabetes: experiences from the Trial to Reduce Insulin-dependent diabetes mellitus in the Genetically at Risk (TRIGR).

    PubMed

    Knip, Mikael; Virtanen, Suvi M; Becker, Dorothy; Dupré, John; Krischer, Jeffrey P; Åkerblom, Hans K

    2011-12-01

    Short-term breastfeeding and early exposure to complex dietary proteins, such as cow milk proteins and cereals, or to fruit, berries, and roots have been implicated as risk factors for β cell autoimmunity, clinical type 1 diabetes, or both. The Trial to Reduce Insulin-dependent diabetes mellitus in the Genetically at Risk (TRIGR) is an international, randomized, double-blind, controlled intervention trial designed to answer the question of whether weaning to an extensively hydrolyzed formula in infancy will decrease the risk of type 1 diabetes later in childhood. In our pilot study, weaning to a highly hydrolyzed formula decreased by ≈ 50% the cumulative incidence of one or more diabetes-associated autoantibodies by a mean age of 4.7 y. This finding was confirmed in a recent follow-up analysis to 10 y of age. Currently, the full-scale TRIGR takes place in 77 centers in 15 countries. The TRIGR initially recruited 5606 newborn infants with a family member affected by type 1 diabetes and enrolled 2159 eligible subjects who carried a risk-conferring HLA genotype. All recruited mothers were encouraged to breastfeed. The intervention lasted for 6-8 mo with a minimum study formula exposure time of 2 mo, and hydrolyzed casein and standard cow milk-based weaning formulas were compared. Eighty percent of the participants were exposed to the study formula. The overall retention rate over the first 5 y was 87%, and protocol compliance was 94%. The randomization code will be opened when the last recruited child turns 10 y of age (ie, in 2017).

  1. 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

  2. Improving diet, activity and wellness in adults at risk of diabetes: randomized controlled trial

    PubMed Central

    Block, G; Azar, K M J; Romanelli, R J; Block, T J; Palaniappan, L P; Dolginsky, M; Block, C H

    2016-01-01

    Objective: The purpose of this analysis is to examine the effect of an algorithm-driven online diabetes prevention program on changes in eating habits, physical activity and wellness/productivity factors. Methods: The intervention, Alive-PD, used small-step individually tailored goal setting and other features to promote changes in diet and physical activity. A 6-month randomized controlled trial was conducted among patients from a healthcare delivery system who had confirmed prediabetes (n =339). Change in weight and glycemic markers were measured in the clinic. Changes in physical activity, diet and wellness/productivity factors were self-reported. Mean age was 55 (s.d. 8.9) years, mean body mass index was 31 (s.d. 4.4) kg m−2, 68% were white and 69% were male. Results: The intervention group increased fruit/vegetable consumption by 3.71 (95% confidence interval (CI) 2.73, 4.70) times per week (effect size 0.62), and decreased refined carbohydrates by 3.77 (95% CI 3.10, 4.44) times per week both significantly (P<0.001) greater changes than in the control group. The intervention group also reported a significantly greater increase in physical activity than in the control group, effect size 0.49, P<0.001. In addition, the intervention group reported a significant increase in self-rated health, in confidence in ability to make dietary changes and in ability to accomplish tasks, and a decrease in fatigue, compared with the control group. These changes paralleled the significant treatment effects on glycemic markers and weight. Conclusions: In addition to promoting improvements in weight and glycemic markers, the Alive-PD program appears to improve eating habits and physical activity, behaviors important not just for diabetes prevention but for those with diagnosed diabetes or obesity. The improvements in wellness/productivity may derive from the diet and activity improvements, and from the satisfaction and self-efficacy of achieving goals. PMID:27643726

  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. 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%...

  7. 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...

  8. 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.

  9. Naltrexone for treatment of impaired awareness of hypoglycemia in type 1 diabetes: A randomized clinical trial

    PubMed Central

    Moheet, Amir; Mangia, Silvia; Kumar, Anjali; Tesfaye, Nolawit; Eberly, Lynn E; Bai, Yun; Kubisiak, Kristine; Seaquist, Elizabeth R

    2016-01-01

    Aims Impaired awareness of hypoglycemia (IAH) is a limiting factor in the treatment of type 1 diabetes (T1D) and is a challenging condition to reverse. The objective of this study was to test the hypothesis that naltrexone therapy in subjects with T1D and IAH will improve counterregulatory hormone response and recognition of hypoglycemia symptoms during hypoglycemia. Methods We performed a pilot randomized double blind trial of 4 weeks of naltrexone therapy (n=10) or placebo (n=12) given orally in subjects with T1D and IAH. Outcome measures included hypoglycemia symptom scores, counterregulatory hormone levels and thalamic activation as measured by cerebral blood flow using MRI during experimental hypoglycemia in all subjects before and after 4 weeks of intervention. Results After 4 weeks of therapy with naltrexone or placebo, no significant differences in response to hypoglycemia were seen in any outcomes of interest within each group. Conclusions In this small study, short-term treatment with naltrexone did not improve recognition of hypoglycemia symptoms or counterregulatory hormone response during experimental hypoglycemia in subjects with T1D and IAH. Whether this lack of effect is related to the small sample size or due to the dose, the advanced stage of study population or the drug itself should be the subject of future investigation. PMID:26345338

  10. 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.

  11. 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.

  12. 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

  13. 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)

  14. 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

  15. Randomized controlled trial using bosentan to enhance the impact of exercise training in subjects with type 2 diabetes mellitus.

    PubMed

    Schreuder, Tim H A; Duncker, Dirk J; Hopman, Maria T E; Thijssen, Dick H J

    2014-11-01

    In type 2 diabetes patients, endothelin (ET) receptor blockade may enhance blood flow responses to exercise training. The combination of exercise training and ET receptor blockade may represent a more potent stimulus than training alone to improve vascular function, physical fitness and glucose homeostasis. We assessed the effect of an 8 week exercise training programme combined with either ET blockade or placebo on vasculature, fitness and glucose homeostasis in people with type 2 diabetes. In a double-blind randomized controlled trial, brachial endothelium-dependent and ‑independent dilatation (using flow-mediated dilatation and glyceryl trinitrate, respectively), glucose homeostasis (using Homeostasis Model Assessment for Insulin Resistance (HOMA-IR)) and physical fitness (maximal cycling test) were assessed in 18 men with type 2 diabetes (60 ± 6 years old). Subjects underwent an 8 week exercise training programme, with half of the subjects receiving ET receptor blockade (bosentan) and the other half a placebo, followed by reassessment of the tests above. Exercise training improved physical fitness to a similar extent in both groups, but we did not detect changes in vascular function in either group. This study suggests that there is no adaptation in brachial and femoral artery endothelial function after 8 weeks of training in type 2 diabetes patients. Endothelin receptor blockade combined with exercise training does not additionally alter conduit artery endothelial function or physical fitness in type 2 diabetes.

  16. 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

  17. 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

  18. 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…

  19. Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): randomised trial

    PubMed Central

    Mann, Eleanor; Prevost, A Toby; Vasconcelos, Joana C; Kellar, Ian; Sanderson, Simon; Parker, Michael; Griffin, Simon; Sutton, Stephen; Kinmonth, Ann Louise

    2010-01-01

    Objective To compare the effect of an invitation promoting informed choice for screening with a standard invitation on attendance and motivation to engage in preventive action. Design Randomised controlled trial. Setting Four English general practices. Participants 1272 people aged 40-69 years, at risk for diabetes, identified from practice registers using a validated risk score and invited to attend for screening. Intervention Intervention was a previously validated invitation to inform the decision to attend screening, presenting diabetes as a serious potential problem, and providing details of possible costs and benefits of screening and treatment in text and pie charts. This was compared with a brief, standard invitation simply describing diabetes as a serious potential problem. Main outcome measures The primary end point was attendance for screening. The secondary outcome measures were intention to make changes to lifestyle and satisfaction with decisions made among attenders. Results The primary end point was analysed for all 1272 participants. 55.8% (353/633) of those in the informed choice group attended for screening, compared with 57.6% (368/639) in the standard invitation group (mean difference −1.8%, 95% confidence interval −7.3% to 3.6%; P=0.51). Attendance was lower among the more deprived group (most deprived third 47.5% v least deprived third 64.3%; P<0.001). Interaction between deprivation and effect of invitation type on attendance was not significant. Among attenders, intention to change behaviour was strong and unaffected by invitation type. Conclusions Providing information to support choice did not adversely affect attendance for screening for diabetes. Those from more socially deprived groups were, however, less likely to attend, regardless of the type of invitation received. Further attention to invitation content alone is unlikely to achieve equity in uptake of preventive services. Trial registration Current Controlled Trials ISRCTN

  20. The haemoglobin glycation index as predictor of diabetes-related complications in the AleCardio trial.

    PubMed

    van Steen, Sigrid Cj; Schrieks, Ilse C; Hoekstra, Joost Bl; Lincoff, A Michael; Tardif, Jean-Claude; Mellbin, Linda G; Rydén, Lars; Grobbee, Diederick E; DeVries, J Hans

    2017-01-01

    The haemoglobin glycation index (HGI) quantifies the interindividual variation in the propensity for glycation and is a predictor of diabetes complications and adverse effects of intensive glucose lowering. We investigated the relevance of HGI as independent predictor of complications by using data of the AleCardio trial. The AleCardio trial randomized 7226 type 2 diabetes patients with an acute coronary syndrome to aleglitazar or placebo. From 6458 patients with baseline glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG), a linear regression equation, HbA1c (%) = 5.45 + 0.0158 * FPG (mg/dl), was used to calculate predicted HbA1c and derive HGI (= observed - predicted HbA1c). With multivariate Cox regression we examined the association with major adverse cardiac events, cardiovascular mortality, total mortality and hypoglycaemia, irrespective of treatment allocation, using HGI subgroups (low, intermediate and high) and HGI as continuous variable. Patients with high HGI were younger, more often non-Caucasian, had a longer duration of diabetes, showed more retinopathy and used insulin more often. Hypoglycaemia occurred less often in the low HGI subgroup, but this difference disappeared after adjustment for duration of diabetes, insulin and sulphonylurea use. Low HGI patients were at lower risk for cardiovascular mortality (hazard ratio 0.64; 95% confidence interval 0.44-0.93, p = 0.020) and total mortality (hazard ratio 0.69; 95% confidence interval 0.50-0.95, p = 0.025), as compared with high HGI patients. Every percentage increase in HGI was associated with a 16% increase in the risk for cardiovascular mortality ( p = 0.005). The association between HGI and mortality disappeared with additional adjustment for HbA1c. HGI predicts mortality in diabetes patients with acute coronary syndromes, but no better than HbA1c.

  1. 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.

  2. 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

  3. 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

  4. Exercise dose and diabetes risk in overweight and obese children: A randomized, controlled trial

    PubMed Central

    Davis, Catherine L; Pollock, Norman K; Waller, Jennifer L; Allison, Jerry D; Dennis, B Adam; Bassali, Reda; Meléndez, Agustín; Boyle, Colleen A; Gower, Barbara A

    2012-01-01

    Context Pediatric studies showed that aerobic exercise reduces metabolic risk, but dose response information is not available. Objective Test the effect of aerobic training dose on insulin resistance, fatness, visceral fat, and fitness in overweight, sedentary children, and test moderation by sex and race. Design, Setting, and Participants Randomized, controlled, efficacy trial from 2003 through 2007, in which 222 overweight or obese, sedentary children (mean age, 9.4 yrs; 42% male, 58% black) were recruited from 15 public schools in the Augusta, GA area. Intervention Low-dose (20 min/d, n = 71) or high-dose (40 min/d, n = 73) aerobic training (13 ± 1.6 wk, 5 d/wk), or control condition (usual physical activity, n = 78); 94% retention. Main outcome measures Prespecified primary outcomes were type 2 diabetes risk at posttest, assessed by insulin area under the curve (AUC) from oral glucose tolerance test, aerobic fitness, percent body fat via dual-energy x-ray absorptiometry, and visceral fat via magnetic resonance, analyzed by intent-to-treat. Results Most children (85%) were obese. At baseline, the mean BMI was 26 (SD = 4.4). Reductions in insulin AUC were larger in the high-dose (adjusted mean difference [95% CI], −3.56 [−6.26 to −0.85], P = .01) than low-dose group (−2.96 [−5.69 to −0.22], P = .03) ×103 μU/mL) vs control group. Dose-response trends were also observed for body fat (−1.4 [−2.2 to −0.7], P < .001; −0.8 [−1.6 to −0.07] %, P =.03) and visceral fat (−3.9 [−6.0 to −1.7], P < .001; −2.8 [−4.9 to −0.6] cm3, P = .01) in the high- and low-dose vs control groups, respectively. Effects in the high- and low-dose groups vs control were similar for fitness (2.4 [0.4 to 4.5], P =.02; 2.4 [0.3 to 4.5] mL/kg/min, P = .03). High- vs. low-dose group effects were similar for these outcomes. There was no moderation by sex or race. Conclusions Three months of 20 or 40 min/d aerobic training improved fitness, and demonstrated dose

  5. 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

  6. Management of diabetes by a healthcare team in a cardiology unit: a randomized controlled trial

    PubMed Central

    de Moraes, Maria Antonieta P; Rodrigues, Juliane; Cremonesi, Mariana; Polanczyk, Carisi; Schaan, Beatriz D

    2013-01-01

    OBJECTIVE: To assess the effectiveness of healthcare team guidance in the implementation of a glycemic control protocol in the non-intensive care unit of a cardiology hospital. METHODS: This was a randomized clinical trial comparing 9 months of intensive guidance by a healthcare team on a protocol for diabetes care (Intervention Group, n = 95) with 9 months of standard care (Control Group, n = 87). Clinicaltrials.gov: NCT01154413. RESULTS: The mean age of the patients was 61.7±10 years, and the mean glycated hemoglobin level was 71±23 mmol/mol (8.7±2.1%). The mean capillary glycemia during hospitalization was similar between the groups (9.8±2.9 and 9.1±2.4 mmol/l for the Intervention Group and Control Group, respectively, p = 0.078). The number of hypoglycemic episodes (p = 0.77), hyperglycemic episodes (47 vs. 50 in the Intervention Group and Control Group, p = 0.35, respectively), and the length of stay in the hospital were similar between the groups (p = 0.64). The amount of regular insulin administered was 0 (0–10) IU in the Intervention Group and 28 (7–56) IU in the Control Group (p<0.001), and the amount of NPH insulin administered was similar between the groups (p = 0.16). CONCLUSIONS: While guidance on a glycemic control protocol given by a healthcare team resulted in a modification of the therapeutic strategy, no changes in glycemic control, frequency of episodes of hypoglycemia and hyperglycemia, or hospitalization duration were observed. PMID:24270950

  7. Enterovirus infections as a risk factor for type I diabetes: virus analyses in a dietary intervention trial.

    PubMed

    Sadeharju, K; Hämäläinen, A-M; Knip, M; Lönnrot, M; Koskela, P; Virtanen, S M; Ilonen, J; Akerblom, H K; Hyöty, H

    2003-05-01

    This study evaluated the possible role of enterovirus infections in the pathogenesis of type I (insulin-dependent) diabetes in a prospective dietary intervention trial. Children participated in the second pilot of the Trial to Reduce IDDM in Genetically at Risk (TRIGR) project. They were randomized into two groups receiving either a casein hydrolysed formula (Nutramigen) or a regular formula, whenever breast milk was not available over the first 6-8 months of life. Altogether 19 children who turned positive for autoantibodies associated with type I diabetes by 2 years of age and 84 matched control children were analysed for enterovirus antibodies and enterovirus RNA in serum. Enterovirus infections were common during the first 2 years of life and more frequent among boys than girls (P = 0.02). Autoantibody-positive children had more enterovirus infections than autoantibody-negative children before the appearance of autoantibodies (0.83 versus 0.29 infection per child, P = 0.01). The average levels of IgG antibodies to echovirus antigen were also higher in autoantibody-positive than in autoantibody-negative children (P = 0.0009). No difference was found in the frequency of enterovirus infections between children receiving the casein hydrolysed formula or regular formula. These results suggest that enterovirus infections are associated with the induction of beta-cell autoimmunity in young children with increased genetic susceptibility to type I diabetes.

  8. Evaluation of the telephone intervention in the promotion of diabetes self-care: a randomized clinical trial 1

    PubMed Central

    Fernandes, Bárbara Sgarbi Morgan; Reis, Ilka Afonso; Torres, Heloisa de Carvalho

    2016-01-01

    ABSTRACT Objective: to evaluate the effectiveness of the telephone intervention for promoting self-care related to physical activity and following a diet plan in users with diabetes, compared to conventional monitoring of users over a six-month period. Method: this was a randomized clinical trial, which included 210 users with diabetes, linked to eight Primary Health Units of Belo Horizonte, Minas Gerais. The experimental group (104 members) received six telephone interventions over the six-month monitoring; the control group (106 members) received conventional monitoring. To evaluate the self-care practices related to physical activity and following a healthy eating plan, in both groups, the self-care questionnaire was applied before the intervention and at three and six months after its start. Results: the mean effect of self-care scores in the experimental group was 1.03 to 1.78 higher than the control group, with progressive and significant improvement (p<0.001). Conclusion: the results indicate that the telephone intervention had a beneficial effect on diabetes self-care. The primary identifier of the clinical trials registry was: RBR-8wx7qb. PMID:27579926

  9. Randomised controlled trial of alternative messages to increase enrolment in a healthy food programme among individuals with diabetes

    PubMed Central

    Gopalan, A; Paramanund, J; Shaw, P A; Patel, D; Friedman, J; Brophy, C; Buttenheim, A M; Troxel, A B; Asch, D A; Volpp, K G

    2016-01-01

    Objectives We compared the effectiveness of diabetes-focused messaging strategies at increasing enrolment in a healthy food programme among adults with diabetes. Methods Vitality is a multifaceted wellness benefit available to members of Discovery Health, a South Africa-based health insurer. One of the largest Vitality programmes is HealthyFood (HF), an incentive-based programme designed to encourage healthier diets by providing up to 25% cashback on healthy food purchases. We randomised adults with type 2 diabetes to 1 of 5 arms: (1) control, (2) a diabetes-specific message, (3) a message with a recommendation of HF written from the perspective of a HF member with diabetes, (4) a message containing a physician's recommendation of HF, or (5) the diabetes-specific message from arm 2 paired with an ‘enhanced active choice’(EAC). In an EAC, readers are asked to make an immediate choice (in this case, to enrol or not enrol); the pros and cons associated with the preferred and non-preferred options are highlighted. HF enrolment was assessed 1 month following the first emailed message. Results We randomised 3906 members. After excluding those who enrolled in HF or departed from the Vitality programme before the first intervention email, 3665 (94%) were included in a modified intent-to-treat analysis. All 4 experimental arms had significantly higher HF enrolment rates compared with control (p<0.0001 for all comparisons). When comparing experimental arms, the diabetes-specific message with the EAC had a significantly higher enrolment rate (12.6%) than the diabetes-specific message alone (7.6%, p=0.0016). Conclusions Messages focused on diabetes were effective at increasing enrolment in a healthy food programme. The addition of a framed active choice to a message significantly raised enrolment rates in this population. These findings suggest that simple, low-cost interventions can enhance enrolment in health promoting programmes and also be pragmatically tested within

  10. No identifiable Hb1Ac or lifestyle change after a comprehensive diabetes programme including motivational interviewing: A cluster randomised trial

    PubMed Central

    2013-01-01

    Abstract Objective To study the effectiveness of a comprehensive diabetes programme in general practice that integrates patient-centred lifestyle counselling into structured diabetes care. Design and setting Cluster randomised trial in general practices. Intervention Nurse-led structured diabetes care with a protocol, record keeping, reminders, and feedback, plus training in motivational interviewing and agenda setting. Subjects Primary care nurses in 58 general practices and their 940 type 2 diabetes patients with an HbA1c concentration above 7%, and a body mass index (BMI) above 25 kg/m2. Main outcome measures HbA1c, diet, and physical activity (medical records and patient questionnaires). Results Multilevel linear and logistic regression analyses adjusted for baseline outcomes showed that despite active nurse participation in the intervention, the comprehensive programme was no more effective than usual care after 14 months, as shown by HbA1c levels (difference between groups = 0.13; CI 20.8–0.35) and diet (fat (difference between groups = 0.19; CI 20.82–1.21); vegetables (difference between groups = 0.10; CI-0.21–0.41); fruit (difference between groups = 20.02; CI 20.26–0.22)), and physical activity (difference between groups = 21.15; CI 212.26–9.97), or any of the other measures of clinical parameters, patient's readiness to change, or quality of life. Conclusion A comprehensive programme that integrated lifestyle counselling based on motivational interviewing principles integrated into structured diabetes care did not alter HbA1c or the lifestyle related to diet and physical activity. We thus question the impact of motivational interviewing in terms of its ability to improve routine diabetes care in general practice. PMID:23659710

  11. Huangqi Guizhi Wuwu Decoction for treating diabetic peripheral neuropathy: a meta-analysis of 16 randomized controlled trials

    PubMed Central

    Pang, Bing; Zhao, Tian-yu; Zhao, Lin-hua; Wan, Fang; Ye, Ru; Zhou, Qiang; Tian, Feng; Tong, Xiao-lin

    2016-01-01

    OBJECTIVE: This meta-analysis was performed to systematically assess the efficacy and safety of the Chinese herbal medicine Huangqi Guizhi Wuwu Decoction (HGWWD) for treating diabetic peripheral neuropathy. DATA SOURCES: Six electronic databases, including the Cochrane Library, MEDLINE database, Chinese Biomedical Database, Chinese National Knowledge Infrastructure Database, Chinese Science and Technique Journals Database, and the Wanfang Database, were searched on the internet for randomized controlled trials published up until 1 December 2015. The search terms included “Chinese herbal medicine”, “diabetic peripheral neuropathy” and “randomized controlled trials” in Chinese and in English. DATA SELECTION: We included randomized controlled trials using HGWWD/modified HGWWD for the treatment group, without restriction for the control group. We assessed literature quality in accordance with the Cochrane Review Handbook. A random or a fixed effects model was used to analyze outcomes using RevMan 5.2 software. OUTCOME MEASURES: The primary outcomes were changes in symptoms and nerve conduction velocities. The secondary outcomes were fasting blood glucose and hemorheological indexes. RESULTS: Sixteen randomized controlled trials, with a total of 1,173 patients, were included. Meta-analysis revealed that the efficacy of HGWWD for diabetic peripheral neuropathy was significantly superior compared with the control treatment (i.e., control group) (risk ratio = 0.36, 95% confidence interval (CI): 0.29–0.46, Z =8.33, P < 0.00001) Compared with the control group, there was an increase in median motor nerve conduction velocity (mean difference (MD) = 3.46, 95%CI: 1.88–5.04, Z = 4.30, P < 0.01) and median sensory nerve conduction velocity (MD = 3.30, 95%CI: 2.04–4.56, Z = 5.14, P < 0.01). There was also an increase in peroneal motor nerve conduction velocity (MD = 3.22, 95%CI: 2.45–3.98, Z = 8.21, P < 0.01) and peroneal sensory nerve conduction velocity (MD

  12. 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.

  13. Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM) on psychological, health behavior, and clinical outcomes. Methods/Design Eligible patients are aged 21 to 65 years with body mass index (BMI) ≥27 kg/m2 and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. Discussion A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling. Trial registration ClinicalTrials.gov Identifier NCT01060540 PMID:22852560

  14. Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial

    PubMed Central

    2008-01-01

    Objective To evaluate the effectiveness of a structured group education programme on biomedical, psychosocial, and lifestyle measures in people with newly diagnosed type 2 diabetes. Design Multicentre cluster randomised controlled trial in primary care with randomisation at practice level. Setting 207 general practices in 13 primary care sites in the United Kingdom. Participants 824 adults (55% men, mean age 59.5 years). Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care. Main outcome measures Haemoglobin A1c levels, blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, and emotional impact of diabetes at baseline and up to 12 months. Main results Haemoglobin A1c levels at 12 months had decreased by 1.49% in the intervention group compared with 1.21% in the control group. After adjusting for baseline and cluster, the difference was not significant: 0.05% (95% confidence interval −0.10% to 0.20%). The intervention group showed a greater weight loss: −2.98 kg (95% confidence interval −3.54 to −2.41) compared with 1.86 kg (−2.44 to −1.28), P=0.027 at 12 months. The odds of not smoking were 3.56 (95% confidence interval 1.11 to 11.45), P=0.033 higher in the intervention group at 12 months. The intervention group showed significantly greater changes in illness belief scores (P=0.001); directions of change were positive indicating greater understanding of diabetes. The intervention group had a lower depression score at 12 months: mean difference was −0.50 (95% confidence interval −0.96 to −0.04); P=0.032. A positive association was found between change in perceived personal responsibility and weight loss at 12 months (β=0.12; P=0.008). Conclusion A structured group education programme for patients with newly diagnosed type 2 diabetes resulted in greater

  15. A randomized clinical trial of diabetes self-management for Mexican Americans: Are there serendipitous health benefits for supporters of study participants?

    PubMed Central

    Brown, Sharon A; García, Alexandra A; Orlander, Philip R; Hanis, Craig L

    2017-01-01

    Objectives: Studies of social support in diabetes have focused on the effects of support on the person with type 2 diabetes. We explored diabetes prevention effects of a culturally tailored diabetes self-management intervention in individuals without diabetes who were supporters of intervention participants. Methods: This is a secondary analysis of data from a randomized clinical trial that involved 256 Mexican Americans with diabetes. Each study participant designated a supporter—spouse, relative, friend—who attended intervention sessions and assisted participants in attaining effective diabetes self-management. Supporter’s glycosylated hemoglobin (A1C) data were tracked for 1 year to determine diabetes conversion rates in supporters without diabetes at baseline. Results: Fewer individuals in the intervention group (n = 9) converted to an A1C above the 7% threshold, compared to the 1-year wait-listed control group (n = 16). We found a statistically significant difference (p = .021) at 12 months in the number of individuals whose A1C was ⩽8%, with fewer supporters above threshold in the intervention group (reduction of 48%). Supporters in the intervention group with prediabetes, based on baseline A1C, experienced a slight reduction in A1C, while control group supporters with prediabetes experienced an increase. Discussion: The results suggest that there are potential benefits for family members and other supporters of persons with diabetes who participated in diabetes self-management programs. PMID:28228947

  16. 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.

  17. 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.

  18. Effectiveness of off-the-shelf footwear in reducing foot pain in Australian Department of Veterans’ Affairs recipients not eligible for medical grade footwear: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Foot pain is highly prevalent in older people, and in many cases is associated with wearing inadequate footwear. In Australia, the Department of Veterans’ Affairs (DVA) covers the costs of medical grade footwear for veterans who have severe foot deformity. However, there is a high demand for footwear by veterans with foot pain who do not meet this eligibility criterion. Therefore, this article describes the design of a randomized controlled trial to evaluate the effectiveness of low cost, off-the-shelf footwear in reducing foot pain in DVA recipients who are currently not eligible for medical grade footwear. Methods One hundred and twenty DVA clients with disabling foot pain residing in Melbourne, Australia, who are not eligible for medical grade footwear will be recruited from the DVA database, and will be randomly allocated to an intervention group or a ‘usual care’ control group. The intervention group will continue to receive their usual DVA-subsidized podiatry care in addition to being provided with low-cost, supportive footwear (Dr Comfort®, Vasyli Medical, Labrador, Queensland, Australia). The control group will also continue to receive DVA-subsidized podiatry care, but will not be provided with the footwear until the completion of the study. The primary outcome measure will be pain subscale on the Foot Health Status Questionnaire (FHSQ), measured at baseline and 4, 8, 12 and 16 weeks. Secondary outcome measures measured at baseline and 16 weeks will include the function subscale of the FHSQ, the Manchester Foot Pain and Disability Index, the number of DVA podiatry treatments required during the study period, general health-related quality of life (using the Short Form 12® Version 2.0), the number of falls experienced during the follow-up period, the Timed Up and Go test, the presence of hyperkeratotic lesions (corns and calluses), the number of participants using co-interventions to relieve foot pain, and participants’ perception of

  19. Canagliflozin-current status in the treatment of type 2 diabetes mellitus with focus on clinical trial data

    PubMed Central

    Bhatia, Jagriti; Gamad, Nanda; Bharti, Saurabh; Arya, Dharamvir Singh

    2014-01-01

    Canagliflozin (CFZ) is a member of new class of glucose lowering agents, sodium-glucose co-transporter (SGLT) inhibitors, which got approval by food and drug administration. It has insulin independent action by blocking the transporter protein SGLT2 in the kidneys, resulting in urinary glucose excretion and reduction in blood glucose levels. In clinical trials, CFZ significantly decreased HbA1c level when administered either as monotherapy or as combined therapy with other anti-diabetic drugs. Intriguingly, it showed additional benefits like weight reduction and lowering of blood pressure. The commonly observed side effects were urinary and genital infections. It has exhibited favorable pharmacokinetic and pharmacodynamic profiles even in patients with renal and hepatic damage. Hence, this review purports to outline CFZ as a newer beneficial drug for type 2 diabetes mellitus. PMID:24936262

  20. Randomized, controlled trial of Behavioral Family Systems Therapy for Diabetes: maintenance and generalization of effects on parent-adolescent communication.

    PubMed

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

    2008-03-01

    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 independent rating of videotaped family problem-solving discussions. BFST-D improved individual communication of adolescents and mothers, but not fathers. BFST-D significantly improved quality of family interaction compared to SC (10 of 12 comparisons) and ES (6 of 12 comparisons). Changes in family communication were differentially associated with changes in glycemic control, adherence, and family conflict. BFST-D improved family communication and problem solving relative to SC and modestly relative to ES.

  1. Writing for Health: Rationale and Protocol for a Randomized Controlled Trial of Internet-Based Benefit-Finding Writing for Adults With Type 1 or Type 2 Diabetes

    PubMed Central

    Wilhelm, Kay; Robins, Lisa; Proudfoot, Judy

    2017-01-01

    Background Diabetes mellitus is Australia’s fastest growing chronic disease, and has high comorbidity with depression. Both subthreshold depression and diabetes distress are common amongst people with type 1 or type 2 diabetes, and are associated with poorer diabetes self-care. A need exists for low-intensity self-help interventions for large numbers of people with diabetes and diabetes distress or subthreshold depression, as part of a stepped-care approach to meeting the psychological needs of people with diabetes. Benefit-finding writing is a very brief intervention that involves writing about any positive thoughts and feelings about a stressful experience, such as an illness. Benefit-finding writing has been associated with increases in positive affect and positive growth, and has demonstrated promising results in trials amongst other clinical populations. However, benefit-finding writing has not yet been examined in people with diabetes. Objective The aim of this randomized controlled trial (RCT) is to evaluate the efficacy of an Internet-based benefit-finding writing (iBFW) intervention for adults with type 1 or type 2 diabetes (compared to a control writing condition) for reducing diabetes distress and increasing benefit-finding in diabetes, and also improving a range of secondary outcomes. Methods A two-arm RCT will be conducted, using the online program Writing for Health. Adults with type 1 or type 2 diabetes living in Australia will be recruited using diabetes-related publications and websites, and through advertisements in diabetes services and general practitioners’ offices. Potential participants will be referred to the study-specific website for participant information and screening. All data will be collected online. Participants will be randomized to either iBFW about diabetes, or a control writing condition of writing about use-of-time. Both conditions involve three daily sessions (once per day for three consecutive days) of 15-minute online

  2. 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

  3. 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

  4. 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

  5. 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

  6. Closing the knowledge gap on cardiovascular disease in type 2 diabetes: the EMPA-REG OUTCOME trial and beyond

    PubMed Central

    Oral, Elif A

    2016-01-01

    Type 2 diabetes mellitus (T2DM) is associated with marked cardiovascular (CV) morbidity and mortality, including heart failure (HF). Until recently, an oral glucose-lowering agent that improved hyperglycemia as well as provided CV benefits in patients with T2DM and cardiovascular disease (CVD) was lacking. The newest class of glucose-lowering agents, sodium glucose cotransporter 2 (SGLT2) inhibitors, includes canagliflozin, dapagliflozin, and empagliflozin. Prior to the release of the LEADER trial results, the recent EMPA-REG OUTCOME study was the only dedicated CV trial to demonstrate a reduction in major adverse cardiac events, CV mortality, and all-cause mortality and a reduction in hospitalization for HF with empagliflozin, given on top of standard-of-care therapy in patients with T2DM and CVD. This paper summarizes the results from EMPA-REG OUTCOME and discusses their significance and clinical implications. PMID:27648101

  7. USSR Report, Economic Affairs.

    DTIC Science & Technology

    2007-11-02

    This report from the USSR contains articles on Economic Affairs. The main topics are Economic Policy, Organization and Management; Resource Utilization and Supply; Regional Development ; and Introduction of New Technology;

  8. USSR Report, Economic Affairs.

    DTIC Science & Technology

    1985-05-22

    This report from the USSR contains articles on Economic Affairs. The main topics are Economic Policy, Organization and Management; Planning and Plan Implementation; Investment, Prices, Budget and Finance; Resource Utilization and Supply; and Regional Development .

  9. USSR Report, Economic Affairs.

    DTIC Science & Technology

    1984-11-16

    This report from the USSR contains articles on Economic Affairs. The main topics are Economic Policy, Organization and Management; Investment, Prices, Budget and Finance; Resource Utilization and Supply and Regional Development .

  10. China Report, Economic Affairs.

    DTIC Science & Technology

    2007-11-02

    This is China Report include Economic Affairs. It contains the issues with different topics on People’s Republic of China: National Policy and Issues, Finance and Banking, Mineral Resources , Domestic Trade, Foreign Trade.

  11. Effect of glycemic treatment and microvascular complications on menopause in women with type 1 diabetes in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) cohort.

    PubMed

    Kim, Catherine; Cleary, Patricia A; Cowie, Catherine C; Braffett, Barbara H; Dunn, Rodney L; Larkin, Mary E; Gatcomb, Patricia M; Wessells, Hunter B; Nathan, David M; Sarma, Aruna V

    2014-01-01

    OBJECTIVE We examined the impact of intensive versus conventional diabetes treatment upon menopause among women with type 1 diabetes in the Diabetes Control and Complications Trial (DCCT), a randomized controlled trial of intensive diabetes treatment, and its observational follow-up, the Epidemiology of Diabetes Interventions and Complications (EDIC) study. RESEARCH DESIGN AND METHODS In a secondary analysis of women in the DCCT/EDIC (n = 657), outcomes were the cumulative incidences of natural menopause and surgical menopause. Cox regression analyses were used to examine associations with treatment group, time-varying estimates of hemoglobin A1c (HbA1c), insulin dosage, BMI, and microvascular complications (retinopathy, nephropathy, and neuropathy). RESULTS By EDIC year 18, after an average of 28 years of follow-up, 240 (38%) women had experienced natural menopause and 115 (18%) women had experienced surgical menopause. Age at natural menopause was similar in the intensive versus conventional groups (49.9 vs. 49.0 years; P = 0.28), and age at surgical menopause was similar in the intensive versus conventional groups (40.8 vs. 42.0 years; P = 0.31). In multivariable models, treatment group, HbA1c, and microvascular complications were not associated with risk of natural or surgical menopause. Each 10 unit/day increase in insulin dosage decreased risk of natural menopause (hazard ratio [HR] 0.91, 95% CI 0.75-0.98) and each kg/m(2) increase in BMI increased risk of surgical menopause (HR 1.08, 95% CI 1.00-1.16). CONCLUSIONS In the DCCT/EDIC, intensive versus conventional treatment group and HbA1c level were not associated with menopause risk. Greater insulin dose was associated with lower menopause risk.

  12. 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

  13. 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

  14. 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...

  15. Eight Weeks of Cosmos caudatus (Ulam Raja) Supplementation Improves Glycemic Status in Patients with Type 2 Diabetes: A Randomized Controlled Trial.

    PubMed

    Cheng, Shi-Hui; Ismail, Amin; Anthony, Joseph; Ng, Ooi Chuan; Hamid, Azizah Abdul; Barakatun-Nisak, Mohd Yusof

    2015-01-01

    Objectives. Optimizing glycemic control is crucial to prevent type 2 diabetes related complications. Cosmos caudatus is reported to have promising effect in improving plasma blood glucose in an animal model. However, its impact on human remains ambiguous. This study was carried out to evaluate the effectiveness of C. caudatus on glycemic status in patients with type 2 diabetes. Materials and Methods. In this randomized controlled trial with two-arm parallel-group design, a total of 101 subjects with type 2 diabetes were randomly allocated to diabetic-ulam or diabetic controls for eight weeks. Subjects in diabetic-ulam group consumed 15 g of C. caudatus daily for eight weeks while diabetic controls abstained from taking C. caudatus. Both groups received the standard lifestyle advice. Results. After 8 weeks of supplementation, C. caudatus significantly reduced serum insulin (-1.16 versus +3.91), reduced HOMA-IR (-1.09 versus +1.34), and increased QUICKI (+0.05 versus -0.03) in diabetic-ulam group compared with the diabetic controls. HbA1C level was improved although it is not statistically significant (-0.76% versus -0.37%). C. caudatus was safe to consume. Conclusions. C. caudatus supplementation significantly improves insulin resistance and insulin sensitivity in patients with type 2 diabetes.

  16. USSR Report, International Affairs

    DTIC Science & Technology

    2007-11-02

    Imperialist Expansion (KNIZHNOYE OBOZRENIYE, No 37, 12 Sep 86) 2 SOCIALIST COMMUNITY AND CEMA AFFAIRS Responses to PRAVDA Query on Direct Economic...Ties’ (Ya. Macheyevich, Yu. Shiryayev; PRAVDA, 13 Oct 86) 4 CEMA Economic Integration Defended Against Bourgeois Attacks (A. Nikolskiy...countries; they also reap a profit of 5 billion dollars. 13080/12859 CSO: 1807/039 SOCIALIST COMMUNITY AND CEMA AFFAIRS RESPONSES TO PRAVDA QUERY ON

  17. USSR Report, International Affairs

    DTIC Science & Technology

    2007-11-02

    AFFAIRS CONTENTS SOCIALIST COMMUNITY AND CEMA AFFAIRS International Scientific Coordinating Conference in USSR (ZARYA VOSTOKA, 30 Oct 86) • ■ • • 1 ...Czechoslovak Meeting on S&T Cooperation With CEMA (EKONOMICHESKAYA GAZETA, No 1 , Jan 87) 2 Non-Use of CEMA Economic Experience Queried (V. G...U.S. Export Control Laws Revised (Moscow in English to North America, 1 Mar 87) 64 Reagan’s 1984 Directive on Concentration Camps Noted (Vadim

  18. 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

  19. Brief intervention to promote smoking cessation and improve glycemic control in smokers with type 2 diabetes: a randomized controlled trial

    PubMed Central

    Li, William H. C.; Wang, M. P.; LAM, T. H.; Cheung, Yannes T. Y.; Cheung, Derek Y. T.; Suen, Y. N.; Ho, K. Y.; Tan, Kathryn C. B.; CHAN, Sophia S. C.

    2017-01-01

    The aim of the study was to examine the effects of a brief stage-matched smoking cessation intervention group compared with a control group (with usual care) in type 2 diabetes mellitus patients who smoked by randomized controlled trial. There were 557 patients, randomized either into the intervention group (n = 283) who received brief (20- minute) individualized face-to-face counseling by trained nurses and a diabetes mellitus-specific leaflet, or a control group (n = 274) who received standard care. Patient follow-ups were at 1 week, 1 month, 3 months, 6 months, and 12 months via telephone, and assessment of smoking status from 2012 to 2014. Patients smoked an average of 14 cigarettes per day for more than 37 years, and more than 70% were in the precontemplation stage of quitting. The primary outcome showed that both the intervention and control groups had similar 7-day point-prevalence smoking abstinence (9.2% vs. 13.9%; p = 0.08). The secondary outcome showed that HbA1c levels with 7.95% [63 mmol/mol] vs. 8.05% [64 mmol/mol], p = 0.49 at 12 months, respectively. There was no evidence for effectiveness in promoting the brief stage-matched smoking cessation or improving glycemic control in smokers with type 2 diabetes mellitus, particularly those in the pre-contemplation stage. PMID:28378764

  20. Determinants of the Changes in Glycemic Control with Exercise Training in Type 2 Diabetes: A Randomized Trial

    PubMed Central

    Zhang, Zhengyu; Earnest, Conrad P.; Smith, Steven R.; Church, Timothy S.; Ravussin, Eric

    2013-01-01

    Aims To assess the determinants of exercise training-induced improvements in glucose control (HbA1C) including changes in serum total adiponectin and FFA concentrations, and skeletal muscle peroxisome proliferator-activated receptor-γ coactivator-1α (PGC-1α) protein content. Methods A sub-cohort (n = 35; 48% men; 74% Caucasian) from the HART-D study undertaking muscle biopsies before and after 9 months of aerobic (AT), resistance (RT), or combination training (ATRT). Results Changes in HbA1C were associated with changes in adiponectin (r = −0.45, P = 0.007). Participants diagnosed with type 2 diabetes for a longer duration had the largest increase in PGC-1α (r = 0.44, P = 0.008). Statistical modeling examining changes in HbA1C suggested that male sex (P = 0.05), non-Caucasian ethnicity (P = 0.02), duration of type 2 diabetes (r = 0.40; P<0.002) and changes in FFA (r = 0.36; P<0.004), adiponectin (r = −0.26; P<0.03), and PGC-1α (r = −0.28; P = 0.02) explain ∼65% of the variability in the changes in HbA1C. Conclusions Decreases in HbA1C after 9 months of exercise were associated with shorter duration of diabetes, lowering of serum FFA concentrations, increasing serum adiponectin concentrations and increasing skeletal muscle PGC-1α protein expression. Trial Registration ClinicalTrials.gov NCT00458133 PMID:23805175

  1. 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.

  2. Diabetes.

    PubMed

    2014-09-23

    Essential facts Type 1 and type 2 diabetes affect 3.2 million people in the UK. Diabetes is associated with serious complications, including heart disease and stroke, which can lead to disability and premature death. It is the leading cause of preventable sight loss in people of working age in the UK. A quarter of people with diabetes will have kidney disease at some point in their lives, and the condition increases the risk of amputation. Good diabetes management has been shown to reduce the incidence of these serious complications.

  3. Baseline characteristics of the Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial population: comparison with other diabetes prevention trials.

    PubMed

    Krum, Henry; McMurray, John J V; Horton, Edward; Gerlock, Teresa; Holzhauer, Bjoern; Zuurman, Lineke; Haffner, Steven M; Bethel, M Angelyn; Holman, Rury R; Califf, Robert M

    2010-04-01

    The Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial is exploring two pharmacological strategies (nateglinide and valsartan, both alone and in combination) in the prevention of overt diabetes mellitus (DM) and the reduction of cardiovascular disease (CVD) in subjects at high risk for these events. In this analysis, we provide baseline characteristics of the randomized NAVIGATOR study population and contrast them with those from other trials of DM prevention. Key eligibility criteria include impaired glucose tolerance (IGT) and impaired fasting glucose (IFG), a history of CVD (in patients aged > or =50 years), and > or =1 cardiovascular risk factor (in patients aged > or =55 years). Baseline demographic characteristics, laboratory findings, cardiovascular risk factors, CVD history, and medication use are described and compared with other trials of DM prevention. The full analysis set of subjects (N = 9306) showed a clustering of risk factors consistent with the metabolic syndrome: high rates of hypertension (77.5%), dyslipidemia (44.7%), increased waist circumference (101.0 cm), and high body mass index (BMI) (47.5% with BMI > or =30 kg/m(2)). A minority of patients had a history of CVD (24.3%); of these, 11.7% had a history of myocardial infarction and most of the remainder had evidence of coronary artery disease. Subjects also had elevated blood pressure (BP) (predominantly systolic) (139.7/82.6 mm Hg), increased serum low-density lipoproteins cholesterol levels (3.27 mmol/L), and borderline elevation of triglyceride levels (1.97 mmol/L). Demographic data, BP, and lipid profiles in NAVIGATOR were similar to those of previous DM prevention trials, which were also based largely on meeting criteria for IGT. Medication use at baseline among NAVIGATOR subjects, which frequently included aspirin, beta-blockers, calcium channel blockers, diuretics, and lipid-lowering agents, reflects enhanced CVD risk. However, little prescribing

  4. 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.

  5. 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

  6. 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

  7. 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

  8. Tailored support for type 2 diabetes patients with an acute coronary event after discharge from hospital – design and development of a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Type 2 diabetes mellitus patients with an acute coronary event (ACE) experience decreased quality of life and increased distress. According to the American Diabetes Association, discharge from the hospital is a time of increased distress for all patients. Tailored support specific to diabetes is scarce in that period. We developed an intervention based on Bandura’s Social Cognitive Theory, Leventhal’s Common Sense Model, and results of focus groups. The aim of this study is to evaluate the effectiveness of the intervention to reduce distress in type 2 diabetes patients who experienced a first ACE. Methods Randomised controlled trial. Two hundred patients are recruited in thirteen hospitals. A diabetes nurse visits the patients in the intervention group (n = 100) at home within three weeks after discharge from hospital, and again after two weeks and two months. The control group (n = 100) receives a consultation by telephone. The primary outcome is diabetes-related distress, measured with the Problem Areas in Diabetes (PAID) questionnaire. Secondary outcomes are well-being, health status, anxiety, depression, HbA1c, blood pressure and lipids. Mediating variables are self-management, self-efficacy and illness representations. Outcomes are measured with questionnaires directly after discharge from hospital and five months later. Biomedical variables are obtained from the records from the primary care physician and the hospital. Differences between groups in change over time are analysed according to the intention-to-treat principle. The Holm-Bonferroni correction is used to adjust for multiplicity. Discussion Type 2 diabetes patients who experience a first ACE need tailored support after discharge from the hospital. This trial will provide evidence on the effectiveness of a supportive intervention in reducing distress in these patients. Trial registration NCT01801631 PMID:24438342

  9. 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; Szentivanyi, Miroslav; Stancak, Branislav; Babcak, Marian; Kycina, Peter; Poliacik, Pavol; Toth, Peter; Sirotiakova, Jana; de Sa, Esteban Lopez; Bueno, Manuel Gomez; Selles, Manuel Martinez; Cabrera, Jose Angel; Freire, Ramon Bover; Gonzalez Juanatey, Jose Ramon; Comin, Josep; Soriano, FranciscoRidocci; Lopez, Alejandro; Vicho, Raul; Lama, Manuel Geraldia; Schaufelberger, Maria; Brunotte, Richard; Ullman, Bengt; Hagerman, Inger; Cizinsky, Stella; Cherng, Wen-Jin; Yu, Wen-Chung; Kuo, Chi-Tai; Chang, Kuan-Cheng; Lai, Wen-Ter; Kuo, Jen-Yuan; Ural, Dilek; Badak, Ozer; Akin, Mustafa; Yigit, Zerrin; Yokusoglu, Mehmet; Yilmaz, Mehmet; Abaci, Adnan; Ebinc, Haksun; Perlman, Richard; Parish, David; Bergin, James; Burnham, Kenneth; Brown, Christopher; Lundbye, Justin; Williams, Celeste; Eisen, Howard; Juneman, Elizabeth; Joseph, Susan; Peberdy, Mary Ann; Peura, Jennifer; Gupta, Vishal; Habet, Kalim; French, William; Mody, Freny; Graham, Susan; Hazelrigg, Monica; Chung, Eugene; Dunlap, Stephanie; Nikolaidis, Lazaros; Najjar, Samer; Katz, Richard; Murali, Srinivas; Izzo, Joseph L.; Callister, Tracy; Phillips, Roland; Lippolis, Nicholas; Winterton, John; Meymandi, Sheba; Heilman, Karl; Oren, Ron; Zolty, Ronald; Brottman, Michael; Gunawardena, D.R.; Adams, Kirkwood; Barnard, Denise; Klapholz, Marc; Fulmer, James

    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

  10. 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

  11. Update on the collaborative interventions for circulation and depression (COINCIDE) trial: changes to planned methodology of a cluster randomized controlled trial of collaborative care for depression in people with diabetes and/or coronary heart disease

    PubMed Central

    2013-01-01

    Background The COINCIDE trial aims to evaluate the effectiveness and cost-effectiveness of a collaborative care intervention for depression in people with diabetes and/or coronary heart disease attending English general practices. Design This update details changes to the cluster and patient recruitment strategy for the COINCIDE study. The original protocol was published in Trials (http://www.trialsjournal.com/content/pdf/1745-6215-13-139.pdf). Modifications were made to the recruitment targets in response to lower-than-expected patient recruitment at the first ten general practices recruited into the study. In order to boost patient numbers and retain statistical power, the number of general practices recruited was increased from 30 to 36. Follow-up period was shortened from 6 months to 4 months to ensure that patients recruited to the trial could be followed up by the end of the study. Results Patient recruitment began on the 01/05/2012 and is planned to be completed by the 30/04/2013. Recruitment for general practices was completed on 31/10/2012, by which time the target of 36 practices had been recruited. The main trial results will be published in a peer-reviewed journal. Conclusion The data from the trial will provide evidence on the effectiveness and cost-effectiveness of collaborative care for depression in people with diabetes and/or coronary heart disease. Trial registration Trial registration number: ISRCTN80309252 PMID:23663556

  12. Web-based cognitive behavioural therapy (W-CBT) for diabetes patients with co-morbid depression: Design of a randomised controlled trial

    PubMed Central

    van Bastelaar, Kim MP; Pouwer, Frans; Cuijpers, Pim; Twisk, Jos WR; Snoek, Frank J

    2008-01-01

    Background Depression is common among people with diabetes, negatively affecting quality of life, treatment adherence and diabetes outcomes. In routine clinical care, diabetes patients have limited access to mental health services and depression therefore often remains untreated. Web-based therapy could potentially be an effective way to improve the reach of psychological care for diabetes patients, at relatively low costs. This study seeks to test the effectiveness of a web-based self-help depression programme for people with diabetes and co-morbid depression. Methods/Design The effectiveness of a web-based self-help course for adults with diabetes with co-morbid depression will be tested in a randomised trial, using a wait-list controlled design. The intervention consists of an 8-week, moderated self-help course that is tailored to the needs of persons living with diabetes and is offered on an individual basis. Participants receive feedback on their homework assignments by e-mail from their coach. We aim to include 286 patients (143/143), as power analyses showed that this number is needed to detect an effect size of 0.35, with measurements at baseline, directly after completing the web-based intervention and at 1, 3, 4 and 6 months follow-up. Patients in the control condition are placed on a waiting list, and follow the course 12 weeks after randomisation. Primary outcomes are depressive symptoms and diabetes-specific emotional distress. Secondary outcomes are satisfaction with the course, perceived health status, self-care behaviours, glycaemic control, and days in bed/absence from work. Questionnaires are administered via the Internet. Discussion The intervention being trialled is expected to help improve mood and reduce diabetes-specific emotional distress in diabetes patients with depression, with subsequent beneficial effects on diabetes self-care and glycaemic outcomes. When proven efficacious, the intervention could be disseminated to reach large groups

  13. Hepatitis C: Clinical Trials

    MedlinePlus

    ... Financial Report (AFR) Budget Submission Recovery Act Resources Business Congressional Affairs Jobs Benefits Booklet Data & Statistics National ... Participation in any clinical trial is voluntary and choosing not to participate will not affect your VA ...

  14. A trial of simple versus intensified dietary modification for prevention of progression to diabetes mellitus in women with impaired glucose tolerance.

    PubMed

    Wein, P; Beischer, N; Harris, C; Permezel, M

    1999-05-01

    Women with impaired glucose tolerance are at high risk of developing noninsulin dependent diabetes mellitus (NIDDM). The Mercy Hospital for Women has a long-term follow-up programme for women with gestational diabetes, which identifies many women with impaired glucose tolerance. Two hundred of these women were entered into a randomized controlled trial of intensive versus routine dietary advice. Seven women were lost to follow-up. The annual incidence rates of diabetes mellitus for the 2 groups were 6.1% (intervention) and 7.3% (control), an incident rate ratio of 0.83, 95% confidence interval 0.47-1.48, p = 0.50. Overall, there was a return to normal glucose tolerance in 44% of patients. Multivariate analysis showed that body mass index, fasting and 2-hour plasma glucose levels at trial entry were significantly associated with an increased risk of diabetes mellitus. Impaired glucose tolerance is an important condition that should be treated with advice about lifestyle modification (diet and/or exercise). We consider that future trials in the management of women with previous gestational diabetes who have impaired glucose tolerance should investigate the effect of pharmacological intervention in addition to diet and/or exercise, the latter providing a therapy that it would be unethical to exclude on the evidence presently available.

  15. 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

  16. 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...

  17. 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...

  18. 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…

  19. Comparison of the Efficacy of a Diabetes Education Programme for Type 1 Diabetes (PRIMAS) in a Randomised Controlled Trial Setting and the Effectiveness in a Routine Care Setting: Results of a Comparative Effectiveness Study

    PubMed Central

    Ehrmann, Dominic; Bergis-Jurgan, Nikola; Haak, Thomas; Kulzer, Bernhard; Hermanns, Norbert

    2016-01-01

    Background The effectiveness of an intervention in clinical practice is often reduced compared to the efficacy demonstrated in a randomised controlled trial (RCT). In this comparative effectiveness study, the RCT-proven efficacy of a diabetes education programme for type 1 diabetic patients (PRIMAS) was compared to the effectiveness observed in an implementation trial (IT) under routine care conditions. Methods 75 patients with type 1 diabetes received PRIMAS through an RCT, whereas 179 patients were observed in an implementation trial. Baseline characteristics and treatment outcomes at the 6-month follow-up (improvement of HbA1c, hypoglycaemia problems, and diabetes-related distress) were compared. Results At baseline, the type 1 diabetic patients in the RCT had a significant longer diabetes duration (18.7±12.3 vs. 13.8±12.7 yrs., p = .005), lower self-efficacy scores (21.9±4.7 vs. 23.7±6.1, p = .02) and a greater number of diabetes complications (0.8±1.3 vs. 0.4±0.9, p = .02). After 6 months, PRIMAS achieved comparable effects under RCT and implementation trial conditions, as demonstrated by improvement in HbA1c (-0.36%±1.1 vs. -0.37±1.2; Δ -0.01, 95% CI -0.33 to 0.31) and hypoglycaemia unawareness (-0.5±1.4 vs. -0.3±1.4; Δ 0.18, 95% CI -0.21 to 0.57). The likelihood of clinical improvement did not depend on the trial setting (RCT vs. IT: OR 1.18, 95% CI 0.60 to 2.33). The participants with worse glycaemic control (OR 1.40, 95% CI 1.02 to 1.92), hypoglycaemia problems (OR 2.13, 95% CI 1.53 to 2.97) or elevated diabetes distress (OR 1.40, 95% CI 1.03 to 1.89) had a better chance of clinical improvement. Conclusions The effectiveness of PRIMAS under routine care conditions was comparable to the efficacy demonstrated in the RCT. Clinical improvement was independent of the setting in which PRIMAS was evaluated. The PRIMAS education programme for type 1 diabetes can be delivered under conditions of routine care without a loss of effectiveness, compared to

  20. Diabetes.

    PubMed

    Lomberk, Gwen

    2009-01-01

    Pancreatologists have often divided research of the pancreas based upon the origin of the function or disease, namely the endocrine or exocrine pancreas. In fact, as a result, many of our meetings and conferences have followed separate paths. Interestingly, among patients with chronic pancreatitis and pancreatic cancer, both disorders of the exocrine pancreas, diabetes is common. However, the clinical features of the diabetes associated with these two differ. Peripheral insulin resistance and hyperinsulinemia are the predominant diabetic traits in pancreatic cancer, while reduced islet cell mass and impaired insulin secretion are observed more often in chronic pancreatitis. The causal relationship between diabetes and pancreatic cancer remains an intriguing but unanswered question. Since diabetes often precedes pancreatic cancer, it is regarded as a potential risk factor for malignancy. On the other hand, there remains the possibility that pancreatic cancer secretes diabetogenic factors. Regardless of how the science ultimately illuminates this issue, there is increasing interest in utilizing screening for diabetes to aid early detection of pancreatic tumor lesions. Therefore, in this issue of Pancreatology and the Web, we explore the topic of diabetes to keep us alert to this very important association, even if we study diseases of the exocrine pancreas.

  1. A Mobile Phone and Web-Based Intervention for Improving Mental Well-Being in Young People With Type 1 Diabetes: Design of a Randomized Controlled Trial

    PubMed Central

    Vatiliotis, Veronica; Verge, Charles F; Holmes-Walker, Jane; Campbell, Lesley V; Wilhelm, Kay; Proudfoot, Judy

    2015-01-01

    Background Young people with type 1 diabetes experience elevated levels of emotional distress that impact negatively on their diabetes self-care, quality of life, and disease-related morbidity and mortality. While the need is great and clinically significant, a range of structural (eg, service availability), psychological (eg, perceived stigma), and practical (eg, time and lifestyle) barriers mean that a majority of young people do not access the support they need to manage the emotional and behavioral challenges of type 1 diabetes. Objective The aim of this study is to examine the effectiveness of a fully-automated cognitive behavior therapy-based mobile phone and Web-based psychotherapeutic intervention (myCompass) for reducing mental health symptoms and diabetes-related distress, and improving positive well-being in this vulnerable patient group. Methods A two-arm randomized controlled trial will be conducted. Young people with type 1 diabetes and at least mild psychological distress will be recruited via outpatient diabetes centers at three tertiary hospitals in Sydney, Australia, and referred for screening to a study-specific website. Data will be collected entirely online. Participants randomized to the intervention group will use the myCompass intervention for 7 weeks, while at the same time a control group will use an active placebo program matched to the intervention on duration, mode of delivery, and interactivity. Results The primary outcome will be mental well-being (ie, depression, anxiety, diabetes-related distress, and positive well-being), for which data will be collected at baseline, post-intervention, and after 3 months follow-up. Secondary outcomes will be functional (work and social functioning and diabetes self-care), biochemical measures (HbA1c), and mental health self-efficacy. We aim to recruit 280 people into the study that will be conducted entirely online. Group differences will be analyzed on an intention-to-treat basis using mixed

  2. 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...

  3. Report from the 2nd Cardiovascular Outcome Trial (CVOT) Summit of the Diabetes and Cardiovascular Disease (D&CVD) EASD Study Group.

    PubMed

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

    2017-03-11

    The 2nd Cardiovascular Outcome Trial (CVOT) Summit of the Diabetes and Cardiovascular Disease (D&CVD) EASD Study Group was held on the 20th-21st October 2016 in Munich. This second Summit was organized in light of recently published CVOTs on diabetes, with the aim of serving as a reference meeting for discussion on this topic. Along with presentations on the results of the most recently published CVOTs, panel discussions on trial implications for reimbursement and the perspective of cardiologists and/or nephrologists, as well as on CVOTs weaknesses and potentials constituted the heart of the program. Future activities of the D&CVD EASD Study Group in 2017 include an annual meeting in Milano and the 3rd CVOT Summit on Diabetes of the D&CVD EASD Study Group, in Munich ( http://www.dcvd.org ).

  4. The Effectiveness of a Peer Coaching Education on Control and Management of Type 2 Diabetes in Women: A Protocol for a Randomized Controlled Trial

    PubMed Central

    Aalaa, Maryam; Sanjari, Mahnaz; Aghaei Meybodi, Hamid Reza; Amini, Mohammad Reza; Qorbani, Mostafa; Adibi, Hossien; Mehrdad, Neda

    2017-01-01

    ABSTRACT Background: Diabetes Education by Peer Coaching is a strategy which helps the patients with diabetes in the field of behavioral and emotional problems. However, the results of studies in this field in other countries could not be generalized in our context. So, the current study aimed to examine the effectiveness of Diabetes Education by Peer Coaching on Diabetes Management. Methods: Outcome variables for patients and peer coaches are measured at baseline and in3,6 and 12 months. The primary outcome consisted of Fasting Blood Sugar (FBS) and HbA1c. Secondary outcomes included Blood Pressure (BP), Body Mass Index (BMI,) Waist-Hip Ratio (WHR), Lipid Profile, diabetes self-care activities, diabetes-related quality of life, depression, and Social Capital levels.Initial analyses compared the frequency of baseline levels of outcome and other variables using a simple Chi-square test, t-test and the Mann-Whitney- U test. Sequential measurements in each group were evaluated by two-way analysis of variance. If significant differences in baseline characteristics were found, analyses were repeated adjusting for these differences using ANOVA and logistic regression for multivariate analyses. Additional analyses were conducted to look for the evidence of effect modification by pre-specified subgroups. Conclusion: The fact is that self-control and self-efficacy in diabetes management and treatment of diabetes could be important components. It seems that this research in this special setting with cultural differences would provide more evidence about peer-coaching model. It seems that if the peer-coaching model improves learning situations between patients with diabetes by offering one-on-one Diabetes Self Management Education, it could be an interactive approach to diabetic education. Trial Registration Number: IRCT201501128175N3

  5. 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

  6. 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

  7. 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

  8. Managing Legal Affairs.

    ERIC Educational Resources Information Center

    Weeks, Richard H.

    2001-01-01

    Discusses school administrators' legal-affairs management responsibilities regarding legal advice, law versus ethics, and sources of law. Suggests strategies for retaining and managing legal counsel and avoiding situations involving litigation, torts, and conflict resolution. Explains general counsel services; outlines education,…

  9. Soviet Union, Military Affairs

    DTIC Science & Technology

    2007-11-02

    agency of the Soviet Union. Permission for further reproduction must be obtained from copyright owner. SOVIET UNION MILITARY AFFAIRS CONTENTS...internationalists, it has always embodied the inviolable friendship of the peoples of the USSR. But are some of us not hypnotized by this principle

  10. 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

  11. Lessons Learned from the HEALTHY Primary Prevention Trial of Risk Factors for Type 2 Diabetes in Middle-School Youth

    PubMed Central

    Marcus, Marsha D.; Kaufman, Francine; Foster, Gary D.; Baranowski, Tom

    2012-01-01

    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 6000 students at 42 middle schools across the US. Half received an integrated intervention program of components addressing the school food environment, physical education, lifestyle behaviors, and promotional messaging. The intervention was designed to be more comprehensive than previous efforts and the research was amply funded. Though the primary objective of reducing percent overweight and obese in schools that received the intervention program compared to control schools was not obtained, key secondary outcomes indicated an intervention effect. In retrospect, senior investigators involved in the study’s design, conduct, and analysis discuss weaknesses and strengths, and offer recommendations for future research efforts that address prevention of childhood obesity from a public health perspective. PMID:23065367

  12. Cost effectiveness of an intensive blood glucose control policy in patients with type 2 diabetes: economic analysis alongside randomised controlled trial (UKPDS 41)

    PubMed Central

    Gray, Alastair; Raikou, Maria; McGuire, Alistair; Fenn, Paul; Stevens, Richard; Cull, Carole; Stratton, Irene; Adler, Amanda; Holman, Rury; Turner, Robert

    2000-01-01

    Objective To estimate the cost effectiveness of conventional versus intensive blood glucose control in patients with type 2 diabetes. Design Incremental cost effectiveness analysis alongside randomised controlled trial. Setting 23 UK hospital clinic based study centres. Participants 3867 patients with newly diagnosed type 2 diabetes (mean age 53 years). Interventions Conventional (primarily diet) glucose control policy versus intensive control policy with a sulphonylurea or insulin. Main outcome measures Incremental cost per event-free year gained within the trial period. Results Intensive glucose control increased trial treatment costs by £695 (95% confidence interval £555 to £836) per patient but reduced the cost of complications by £957 (£233 to £1681) compared with conventional management. If standard practice visit patterns were assumed rather than trial conditions, the incremental cost of intensive management was £478 (−£275 to £1232) per patient. The within trial event-free time gained in the intensive group was 0.60 (0.12 to 1.10) years and the lifetime gain 1.14 (0.69 to 1.61) years. The incremental cost per event-free year gained was £1166 (costs and effects discounted at 6% a year) and £563 (costs discounted at 6% a year and effects not discounted). Conclusions Intensive blood glucose control in patients with type 2 diabetes significantly increased treatment costs but substantially reduced the cost of complications and increased the time free of complications. PMID:10818026

  13. 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

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

    2016-03-01

    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].

  14. 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

  15. 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

  16. Effect of sulodexide on urinary biomarkers of kidney injury in normoalbuminuric type 2 diabetes: a randomized controlled trial.

    PubMed

    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.

  17. Web-based self-management with and without coaching for type 2 diabetes patients in primary care: design of a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Self-management is recognized as the cornerstone of overall diabetes management. Web-based self-management programs have the potential of supporting type 2 diabetes patients with managing their diabetes and reducing the workload for the care provider, where the addition of online coaching could improve patient motivation and reduce program attrition. This study aims to test the hypothesis that a web-based self-management program with coaching will prove more effective on improving patient self-management behavior and clinical outcome measures than a web-based self-management program without coaching. Methods The effects of a web-based self-management program with and without coaching will be tested with a nested randomized controlled trial within a healthcare group in the Netherlands. In one year 220 type 2 diabetes patients will be randomized into an intervention group (n = 110) or a control group (n = 110). The control group will receive only the online self-management program. The intervention group will receive the online self-management program and additional online coaching. Participants will be followed for one year, with follow-up measurements at 6 and 12 months. Discussion The intervention being tested is set to support type 2 diabetes patients with their diabetes self-management and is expected to have beneficial effects on self-care activities, well being and clinical outcomes. When proven effective this self-management support program could be offered to other health care groups and their type 2 diabetes patients in the Netherlands. Trial registration Nederlands Trial Register NTR4064 PMID:24238104

  18. Student Affairs Researcher: Information Broker.

    ERIC Educational Resources Information Center

    Hadley, Thomas D.

    1999-01-01

    Examines the skills and research tools necessary for the student affairs researcher to become an agent for organizational learning within the student affairs division and the institution. Draws upon Peter Senge's theory of "The Learning Organization" and discusses the resulting implications for student affairs researchers. (GCP)

  19. Multisystemic Therapy Compared to Telephone Support for Youth with Poorly Controlled Diabetes: Findings From A Randomized Controlled Trial

    PubMed Central

    Ellis, Deborah A.; Naar-King, Sylvie; Chen, Xinguang; Moltz, Kathleen; Cunningham, Phillippe B.; Idalski-Carcone, April

    2012-01-01

    Background Few interventions have effectively improved health outcomes among youth with diabetes in chronic poor metabolic control. Purpose To determine whether Multisystemic Therapy (MST), an intensive, home-based, tailored family treatment, was superior to weekly telephone support for improving regimen adherence and metabolic control among adolescents with chronic poor metabolic control. Methods A randomized controlled trial was conducted with 146 adolescents with type 1 or 2 diabetes. Data were collected at baseline, seven months (treatment termination) and twelve months (six month follow-up). Results Adolescents receiving MST had significantly improved metabolic control at seven (1.01% decrease) and twelve months (0.74% decrease) compared to adolescents in telephone support. Parents of adolescents receiving MST reported significant improvements in adolescent adherence. However, adolescent-reported adherence was unchanged. Conclusions MST improved health outcomes among adolescents with chronic poor metabolic control when compared to telephone support. Home-based approaches may provide a viable means to improve access to behavioral interventions for such youth. PMID:22644587

  20. 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

  1. 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

  2. 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

  3. 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

  4. Vitamin D supplementation in obese type 2 diabetes subjects in Ajman, UAE: a randomized controlled double-blinded clinical trial

    PubMed Central

    Sadiya, A; Ahmed, S M; Carlsson, M; Tesfa, Y; George, M; Ali, S H; Siddieg, H H; Abusnana, S

    2015-01-01

    Objectives: To study the effect of Vitamin D3 supplementation on metabolic control in an obese type 2 diabetes Emirati population. Methods: This randomized double-blind clinical trial was conducted with 87 vitamin D-deficient obese, type 2 diabetic participants. The vitamin D-group (n=45) and the placebo group (n=42) were matched for gender, age, HbA1c and 25-hydroxy vitamin D (25(OH) D) at the baseline. The study was divided into two phases of 3 months each; in phase 1, the vitamin D-group received 6000 IU vitamin D3/day followed by 3000 IU vitamin D3/day in phase 2, whereas the placebo group (n=42) received matching placebo. Results: After supplementation, serum 25(OH) D peaked in the vitamin D-group in phase 1 (77.2±30.1 nmol/l, P=0.003) followed by a decrease in the phase 2 (61.4±18.8 nmol/l, P=0.006), although this was higher compared with baseline. In the placebo group, no difference was observed in the serum 25(OH) D levels throughout the intervention. Relative to baseline serum, parathyroid hormone decreased 24% (P=0.003) in the vitamin D-group in phase 2, but remained unchanged in the placebo group. No significant changes were observed in blood pressure, fasting blood glucose, HbA1c, C-peptide, creatinine, phosphorous, alkaline phosphatase, lipids, C-reactive protein or thyroid stimulating hormone concentrations compared with baseline in either group. Conclusions: Six months of vitamin D3 supplementation to vitamin D-deficient obese type 2 diabetes patients in the UAE normalized the vitamin D status and reduced the incidence of eucalcemic parathyroid hormone elevation but showed no effect on the metabolic control. PMID:25406966

  5. 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

  6. 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.

  7. Determination of Efficacy of Reflexology in Managing Patients with Diabetic Neuropathy: A Randomized Controlled Clinical Trial

    PubMed Central

    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

  8. 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

  9. In vitro activity of tigecycline against patient isolates collected during phase 3 clinical trials for diabetic foot infections.

    PubMed

    Petersen, Peter J; Ruzin, Alexey; Tuckman, Margareta; Jones, C Hal

    2010-04-01

    The in vitro activity of tigecycline and comparative antimicrobial agents was evaluated against 1828 primary baseline pathogens isolated from 844 patients enrolled in the phase 3 clinical trials investigating the efficacy of tigecycline in diabetic foot infection (DFI). The trials were global, enrolling patients in 30 countries. Tigecycline was active against the most prevalent pathogens in DFI, including Gram-positive and Gram-negative isolates of both aerobic and anaerobic bacteria with 95% of MICs < or =2 microg/mL for the entire collection. The spectrum of activity of tigecycline included important pathogens for DFI, such as Staphylococcus aureus, Enterococcus faecalis, Streptococcus agalactiae, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis. As reported previously, Pseudomonas aeruginosa and several pathogens in the Proteeae group were generally less susceptible to tigecycline by comparison to other Gram-negative pathogens. The excellent in vitro expanded broad-spectrum activity of tigecycline in the clinical isolates confirmed the potential utility of tigecycline for pathogens associated with DFIs.

  10. 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

  11. 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.

  12. Conservative surgical approach versus non-surgical management for diabetic neuropathic foot ulcers: a randomized trial.

    PubMed

    Piaggesi, A; Schipani, E; Campi, F; Romanelli, M; Baccetti, F; Arvia, C; Navalesi, R

    1998-05-01

    To test the efficacy of surgical treatment of non-infected neuropathic foot ulcers compared to conventional non-surgical management, a group of diabetic outpatients attending our diabetic foot clinic were studied. All patients who came to the clinic for the first time from January to December 1995 inclusive with an uncomplicated neuropathic ulcer were randomized into two groups. Group A received conservative treatment, consisting of relief of weight-bearing, regular dressings; group B underwent surgical excision, eventual debridement or removal of bone segments underlying the lesion and surgical closure. Healing rate, healing time, prevalence of infection, relapse during a 6-month period following intervention and subjective discomfort were assessed. Twenty-four ulcers in 21 patients were treated in group A (17 Type 2 DM/3 Type 1 DM, age 63.24 +/- 13.46 yr, duration of diabetes 18.2 +/- 8.41 yr, HbA1c 9.5 +/- 3.8%) and 22 ulcers in 21 patients in group B (19 Type 2 DM/2 Type 1 DM, age 65.53 +/- 9.87yr, duration of diabetes 16.84 +/- 10.61 yr; HbA1c 8.9 +/- 2.2%). Healing rate was lower (79.2% = 19/24 ulcers) in group A than in group B (95.5% = 21/22 ulcers; p < 0.05), and healing time was longer (128.9 +/- 86.60 days vs 46.73 +/- 38.94 days; p < 0.001). Infective complications occurred significantly more often in group A patients (3/24, 12.5% vs 1/22, 4.5%; p < 0.05), as did relapses of ulcerations (8 vs 3; p < 0.01). There were only two minor perioperative complications in group B patients. Patients reported a higher degree of satisfaction in group B (p < 0.01) as well as lower discomfort (p < 0.05) and restrictions (p < 0.05). Thus surgical treatment of neuropathic foot ulcers in diabetic patients proved to be an effective approach compared to conventional treatment in terms of healing time, complications, and relapses, and can be safely performed in an outpatient setting.

  13. 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

  14. 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.

  15. 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

  16. Effects of Continuous Care Model Based Non-Pharmacological Intervention on Sleep Quality in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial

    PubMed Central

    Khosravan, Shahla; Alami, Ali; Golchin Rahni, Somayyeh

    2015-01-01

    Background Sleep is an important aspect of healthy lifestyle. One of the prevalent Diabetes mellitus-related non-vascular complications is sleep problems. The aim of this study was to investigate the effects of a non-pharmacological care plan designed based on the Continuous Care Model (CCM) on sleep quality in patients with type II diabetes with two month follow up. Methods This randomized controlled clinical trial was conducted from May to November 2012 among 68 the patients with type II DM referring to the Diabetes Clinic of Gonabad University of Medical Sciences. The study instrument consisted of a self-report demographic questionnaire and the Pittsburgh Sleep Quality Index. The gathered data were analyzed via SPSS (V. 20) using t-test and Chi-square statistics. Results After the intervention, the study groups did not differ significantly in terms of sleep quality (0.628). However, the study findings revealed that the interventional group’s sleep quality improved significantly after the intervention (P<0.001). Conclusion Non-pharmacologic intervention according to CCM improved the sleep quality in the experimental group. Sleep care is a matter of great importance in diabetes mellitus, which deserves particular attention. The present study adds to the growing literature of the use of non-pharmaceutics intervention to improve sleep disorders of diabetic patients. Trial Registration Number: IRCT201202269140N1. PMID:26005689

  17. The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial

    PubMed Central

    2012-01-01

    Background Shared decision making contributes to high quality healthcare by promoting a patient-centered approach. Patient involvement in selecting the components of a diabetes medication program that best match the patient’s values and preferences may also enhance medication adherence and improve outcomes. Decision aids are tools designed to involve patients in shared decision making, but their adoption in practice has been limited. In this study, we propose to obtain a preliminary estimate of the impact of patient decision aids vs. usual care on measures of patient involvement in decision making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization. In addition, we propose to identify, describe, and explain factors that promote or inhibit the routine embedding of decision aids in practice. Methods/Design We will be conducting a mixed-methods study comprised of a cluster-randomized, practical, multicentered trial enrolling clinicians and their patients (n = 240) with type 2 diabetes from rural and suburban primary care practices (n = 8), with an embedded qualitative study to examine factors that influence the incorporation of decision aids into routine practice. The intervention will consist of the use of a decision aid (Statin Choice and Aspirin Choice, or Diabetes Medication Choice) during the clinical encounter. The qualitative study will include analysis of video recordings of clinical encounters and in-depth, semi-structured interviews with participating patients, clinicians, and clinic support staff, in both trial arms. Discussion Upon completion of this trial, we will have new knowledge about the effectiveness of diabetes decision aids in these practices. We will also better understand the factors that promote or inhibit the successful implementation and normalization of medication choice decision aids in the care of chronic patients in primary care practices. Trial registration

  18. USSR Report Military Affairs

    DTIC Science & Technology

    2007-11-02

    the after- math of the Chernobyl Nuclear Power Plant accident and the mobilization of labor and technology in the clean-up effort will be published...in the series USSR REPORT: POLITICAL AND SOCIOLOGICAL AFFAIRS under the subtitle AFTERMATH OF CHERNOBYL NUCLEAR POWER PLANT ACCIDENT. This is a...EDITORIALIZES CHERNOBYL ACCIDENT Kiev PRAVDA UKRAINY in Russian 14 May 86 p 1 TRANSPORT WORKERS» EFFORTS AT CHERNOBYL DETAILED Moscow SOTSIALISnCHESKAYA

  19. USSR Report, Military Affairs

    DTIC Science & Technology

    1986-07-29

    math of the Chernobyl Nuclear Power Plant accident and the mobilization of labor and technology in the clean-up effort will be published in the series...USSR REPORT: POLITICAL AND SOCIOLOGICAL AFFAIRS under the subtitle AFTERMATH OF CHERNOBYL NUCLEAR POWER PLANT ACCIDENT. This is a represen- tative... CHERNOBYL ACCIDENT Kiev PRAVDA UKRAINY in Russian 14 May 86 p 1 TRANSPORT WORKERS’ EFFORTS AT CHERNOBYL DETAILED Moscow SOTSIALISTiaESKAYA INDUSTRIYA

  20. USSR Report, International Affairs

    DTIC Science & Technology

    2007-11-02

    4 SOCIALIST COMMUNITY AND CEMA AFFAIRS CEMA Secretary Descibes Priorities, Tasks (V. V. Sychev; EKONOMICHESKAYA GAZETA, No 48, Nov 86...7 Improvement in CEMA Trade Situation Noted by UN (Moscow Domestic Service, 1 Dec 86) 13 CEMA Science, Technology Goals Outlined (Vladimir...Pasko; Moscow Domestic Service, 17 Dec 86) ... 15 Role of Soviet Republics Under CEMA Division of Labor CN. Stepanova; KOMMUNIST MOLDAVII, No 9, Sep

  1. USSR Report. International Affairs.

    DTIC Science & Technology

    2007-11-02

    Opens Soviet Envoy Addresses Forum 2 EAST-WEST RELATIONS History, Prospects for EC- CEMA Cooperation (Vladimir G. Baranovskiy; OBSHCHESTVENNYYE NAUKI...No 6, 1986) 4 SOCIALIST COMMUNITY AND CEMA AFFAIRS USSR Exports and Cooperation With CEMA Countries (B. A. Kheyfets; IZVESTIYA AKADEMII NAUK...EAST-WEST RELATIONS HISTORY, PROSPECTS FOR EC- CEMA COOPERATION Moscow OBSHCHESTVENNYYE NAUKI in Russian No 6, 1986 pp 95-108 [Article by Vladimir

  2. Korean Affairs Report

    DTIC Science & Technology

    2007-11-02

    publications contain information primarily from foreign newspapers, periodicals and books, but also from news agency transmissions and broadcasts...Pyongyang Domestic Service, 23 Dec 86) l Commentary on White Paper About Kumgangsan Dam (Cho Tu-ul; Pyongyang Domestic Service, 26 Dec 86) 3 Party...ruin. /8309 CSO: 4110/056 INTER-KOREAN AFFAIRS COMMENTARY ON WHITE PAPER ABOUT KUMGANGSAN DAM SK280105 Pyongyang Domestic Service in Korean 1150

  3. China Report, Economic Affairs

    DTIC Science & Technology

    2007-11-02

    namely: No clear distinction was drawn between the functions of the government and those of the enterprises; barriers exist between different...enterprise functions in state-owned enterprises became more manifest, administrative control by state organs over economic affairs was strengthened...planned economy as incompatible with the commodity economy; seeing the functions of the socialist state in managing the economy as a monopoly in which

  4. 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

  5. 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

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

    PubMed

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

    2016-05-01

    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 m(2)) 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.

  7. [Trial treatment of diabetic retinopathy by inhibition of pituitary somatotropin secretion with MAP].

    PubMed

    Bruni, B; Bruni-Bocher, K; Della Valle, A; Gamba, S

    1975-03-21

    The recent literature relating to the pathogenesis of diabetic retinopathy, with or without nephropaty, is critically reviewed. Particular attention is given to the Growth Hormone (GH) hypothesis. The various procedures of hypophysectomy are discussed, including the possible ways of suppressing growth hormone production or overproduction by drugs, and expecially by medroxyprogesterone acetate (MAP). Personal results obtained with long-term administration of MAP in deposit form on alternate days in 10 patients with advanced retinopathy are described. An icostant and rely significant suppression of the GH response to insulin-induced hypoglicemia was noted in 6 cases, showing that a complete pituitary inactivation had been achieved. Therefore, the modifications observed in the fundus picture (studied with retinal photographs according to the Hammersmith Hospital Standards) seem to have no relationship with such a condition. The features involved were Microaneurysms and Haemorrhages (HAEMS) and Exudates (EX);New Vessels (NV) and Retinitis Proliferans (RP) were unaffected. Subjective improvement is visual acuity appeared to be more frequent, with various possible explanations. MAP was without appreciable effect on the clinical and metabolic course of the diabetes, or on renal function in cases of concomitant nephropathy. In the light of these preliminary results, further investigations might seem to be justified.

  8. Diabetes

    MedlinePlus

    ... retinopathy gets worse, it may lead to blindness.Laser surgery can often be used to treat or slow down retinopathy, especially if the problem is found early. People who have diabetes should have an eye exam once a year.Warning signs of eye problemsCall your doctor if you ...

  9. 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

  10. 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

  11. 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.

  12. 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

  13. A Trial-Based Economic Evaluation Comparing Spinal Cord Stimulation With Best Medical Treatment in Painful Diabetic Peripheral Neuropathy.

    PubMed

    Slangen, Rachel; Faber, Catharina G; Schaper, Nicolaas C; Joosten, Elbert A; van Dongen, Robert T; Kessels, Alfons G; van Kleef, Maarten; Dirksen, Carmen D

    2017-04-01

    The objective was to perform an economic evaluation comparing spinal cord stimulation (SCS) in combination with best medical treatment (BMT) with BMT in painful diabetic peripheral neuropathy patients. Alongside a prospective 2-center randomized controlled trial, involving 36 painful diabetic peripheral neuropathy patients with severe lower limb pain not responding to conventional therapy, an economic evaluation was performed. Incremental cost-effectiveness ratios were based on: 1) societal costs and quality-adjusted life years (QALYs), and 2) direct health care costs and the number of successfully treated patients, respectively, both with a time horizon of 12 months. Bootstrap and secondary analyses were performed to address uncertainty. Total societal cost amounted to €26,539.18 versus €5,313.45 per patient in the SCS and BMT group, respectively. QALYs were .58 versus .36 and the number of successfully treated patients was 55% versus 7% for the SCS and BMT group, respectively. This resulted in incremental cost-effectiveness ratios of €94,159.56 per QALY and €34,518.85 per successfully treated patient, respectively. Bootstrap analyses showed that the probability of SCS being cost-effective ranges from 0 to 46% with willingness to pay threshold values ranging between €20,000 and €80,000 for a QALY. Secondary analyses showed that cost-effectiveness of SCS became more favorable after correcting for baseline cost imbalance between the 2 groups, extending the depreciation period of SCS material to 4 years, and extrapolation of the data up to 4 years. Although SCS was considerably more effective compared with BMT, the substantial initial investment that is required resulted in SCS not being cost-effective in the short term. Cost-effectiveness results were sensitive to baseline cost imbalances between the groups and the depreciation period of the SCS material.

  14. 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

  15. Repeated Remote Ischemic Conditioning Effect on Ankle-brachial Index in Diabetic Patients - A Randomized Control Trial

    PubMed Central

    Shahvazian, Najmeh; Rafiee, Mansour; Rahmanian, Masoud; Razavi-ratki, Seyed Kazem; Farahzadi, Mohammad Hadi

    2017-01-01

    Background: Remote ischemic preconditioning (RIPC) is a phenomenon where a short period of ischemia in one organ protects against further ischemia in the other organs. We hypothesized that RIPC occurring in diabetic patients with ankle brachial index (ABI) between 0.70 and 0.90 were included with peripheral arterial disease, would make the better coronary flow resulted in the increasing ABI. Materials and Methods: This randomized clinical trial study was done in the Afshar Cardiovascular Hospital in Yazd between 2013 and 2014. Sixty participants were randomly divided into two groups (intervention and control groups). The intervention group was undergoing RIPC, and the control group was tested without RIPC. RIPC was stimulated by giving three cycles of 5 min of ischemia followed by 5 min of reperfusion of both upper arms using a blood pressure cuff inflated to 200 mm Hg (n = 30). This was compared with no RIPC group which consisted of placing a deflated blood pressure cuff on the upper limbs (n = 30). Results: The mean of ABI level before intervention in the RIPC and control group group was 0.82 ± 0.055 and 0.83 ± 0.0603 (P = 0.347) respectively, with no significant difference. It was 0.86 ± 0.066 in the RIPC group compared the control 0.83 ± 0.0603 (P = 0.046). So levels of ABI were greater after intervention in the RIPC group. The mean of ABI level increase from 0.82 ± 0.05 to 0.86 ± 0.06 in RIPC group (P = 0.008). So the intervention group showed a significant increase in ABI. Conclusions: RIPC through using a simple, noninvasive technique, composing three cycles of 5 min-ischemia of both upper arms, showing a significant increase in ABI level in diabetic patients.

  16. 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

  17. Resist diabetes: A randomized clinical trial for resistance training maintenance in adults with prediabetes

    PubMed Central

    Davy, Brenda M.; Winett, Richard A.; Savla, Jyoti; Marinik, Elaina L.; Baugh, Mary Elizabeth; Flack, Kyle D.; Halliday, Tanya M.; Kelleher, Sarah A.; Winett, Sheila G.; Williams, David M.; Boshra, Soheir

    2017-01-01

    Objective To determine whether a social cognitive theory (SCT)-based intervention improves resistance training (RT) maintenance and strength, and reduces prediabetes prevalence. Research design and methods Sedentary, overweight/obese (BMI: 25–39.9 kg/m2) adults aged 50–69 (N = 170) with prediabetes participated in the 15-month trial. Participants completed a supervised 3-month RT (2×/wk) phase and were randomly assigned (N = 159) to one of two 6-month maintenance conditions: SCT or standard care. Participants continued RT at a self-selected facility. The final 6-month period involved no contact. Assessments occurred at baseline and months 3, 9, and 15. The SCT faded-contact intervention consisted of nine tailored transition (i.e., supervised training to training alone) and nine follow-up sessions. Standard care involved six generic follow-up sessions. Primary outcomes were prevalence of normoglycemia and muscular strength. Results The retention rate was 76%. Four serious adverse events were reported. After 3 months of RT, 34% of participants were no longer prediabetic. This prevalence of normoglycemia was maintained through month 15 (30%), with no group difference. There was an 18% increase in the odds of being normoglycemic for each % increase in fat-free mass. Increases in muscular strength were evident at month 3 and maintained through month 15 (P<0.001), which represented improvements of 21% and 14% for chest and leg press, respectively. Results did not demonstrate a greater reduction in prediabetes prevalence in the SCT condition. Conclusions Resistance training is an effective, maintainable strategy for reducing prediabetes prevalence and increasing muscular strength. Future research which promotes RT initiation and maintenance in clinical and community settings is warranted. Trial Registration ClinicalTrials.gov NCT01112709. PMID:28231265

  18. 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

  19. Effects of Thiazolidinedione Therapy on Inflammatory Markers of Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Chen, Rui; Yan, Jinchuan; Liu, Peijing; Wang, Zhongqun

    2015-01-01

    Background Inflammation is a common feature in patients with type 2 diabetes mellitus (T2DM). This meta-analysis aimed to assess the influence of thiazolidinedione (TZD) therapy on the circulating levels of inflammatory markers in patients with T2DM. Methods and Results We searched the databases Medline, Embase, ScienceDirect, Web of Science, SpringerLink, and the Cochrane Library for randomized controlled trials (RCTs) that examined the effects of thiazolidinedione vs. a placebo on patients with T2DM. The main outcomes were absolute changes in levels of circulating inflammatory markers. Twenty-seven RCTs were included and data were analyzed using a fixed-effect model or a random-effect model based on heterogeneity. Pooled results indicated that circulating levels of high-sensitivity C reactive protein (hsCRP; SMD = –0.65, 95% CI = –0.98 to –0.32, p < 0.01), monocyte chemoattractant protein-1 (MCP-1; WMD = –54.19, 95% CI = –73.86 to –34.52, p < 0.01), von Willebrand factor% (vWF%; WMD = –8.18, 95% CI = –13.54 to –2.81, p 0.01), fibrinogen (SMD = –0.26, 95% CI = –0.41 to –0.11, p < 0.01) and E-selectin(WMD = –3.57, 95% CI = –5.59 to -1.54, p <0.01) were significantly decreased after TZD therapy. However, interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), soluble CD40 ligand, plasminogen activator inhibitor 1 (PAI-1) and intercellular adhesion molecule (ICAM-1) were not significantly affected. Subgroup analyses of PAI-1, vWF% and fibrinogen in terms of trial drugs showed significant reductions for rosiglitazone (all p valuses< 0.05), but not pioglitazone treatment. Conversely, the E-selectin (p < 0.01) lowering effect only existed in the pioglitazone group. Further, rosiglitazone and pioglitazone treatment reduced serum hsCRP and MCP-1 but had no marked effects on MMP-9, IL-6 and ICAM-1. Conclusions Limited evidence suggested that TZD therapy had anti-inflammatory property that might contribute to its beneficial effect on

  20. Aseptically Processed Placental Membrane Improves Healing of Diabetic Foot Ulcerations: Prospective, Randomized Clinical Trial

    PubMed Central

    DiDomenico, Lawrence A.; Orgill, Dennis P.; Galiano, Robert D.; Serena, Thomas E.; Carter, Marissa J.; Kaufman, Jarrod P.; Young, Nathan J.

    2016-01-01

    Background: Allogeneic grafts derived from amnion/chorion are known to be efficacious in healing chronic diabetic foot ulcerations (DFUs). The goal of this study was to compare aseptically processed dehydrated human amnion and chorion allograft (dHACA) versus standard of care (SOC) in facilitating wound closure in nonhealing DFUs. Methods: Patients with DFUs treated with SOC (off-loading, appropriate debridement, and moist wound care) after a 2-week screening period were randomized to either SOC or wound-size-specific dHACA (AmnioBand, Musculoskeletal Transplant Foundation, Edison, N.J.) applied weekly for up to 12 weeks plus SOC. Primary endpoint was the percentage of wounds healed at 6 weeks between groups. Results: At 6 weeks, 70% (14/20) of the dHACA-treated DFUs healed compared with 15% (3/20) treated with SOC alone. Furthermore, at 12 weeks, 85% (17/20) of the DFUs in the dHACA group healed compared with 25% (5/20) in the SOC group, with a corresponding mean time to heal of 36 and 70 days, respectively. At 12 weeks, the mean number of grafts used per healed wound for the dHACA group was 3.8 (median 3.0), and mean cost of the tissue to heal a DFU was $1400. The mean wastage at 12 weeks was 40%. One adverse event and 1 serious adverse event occurred in the dHACA group; neither was graft related. Three adverse events and 1 serious adverse event occurred in the SOC group. Conclusion: Aseptically processed dHACA heals diabetic foot wounds significantly faster than SOC at 6 and 12 weeks with minimal graft wastage. PMID:27826487

  1. 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

  2. A randomized, double-blind, placebo-controlled trial to assess safety and tolerability during treatment of type 2 diabetes with usual diabetes therapy and either Cycloset™ or placebo

    PubMed Central

    Scranton, Richard E; Gaziano, J Michael; Rutty, Dean; Ezrokhi, Michael; Cincotta, Anthony

    2007-01-01

    Background Cycloset™ is a quick-release formulation of bromocriptine mesylate, a dopamine agonist, which in animal models of insulin resistance and type 2 diabetes acts centrally to reduce resistance to insulin- mediated suppression of hepatic glucose output and tissue glucose disposal. In such animals, bromocriptine also reduces hepatic triglyceride synthesis and free fatty acid mobilization, manifesting decreases in both plasma triglycerides and free fatty acids. In clinical trials, morning administration of Cycloset™ either as monotherapy or adjunctive therapy to sulfonylurea or insulin reduces HbA1c levels relative to placebo by 0.55–1.2. Cycloset™ therapy also reduces plasma triglycerides and free fatty acid by approximately 25% and 20%, respectively, among those also receiving sulfonylurea therapies. The effects of once-daily morning Cycloset™ therapy on glycemic control and plasma lipids are demonstrable throughout the diurnal portion of the day (7 a.m. to 7 p.m.) across postprandial time points. Methods/Design 3,095 individuals were randomized in a 2:1 ratio into a one year trial aimed to assess the safety and efficacy of Cycloset™ compared to placebo among individuals receiving a variety of treatments for type 2 diabetes. Eligibility criteria for this randomized placebo controlled trial included: age 30–80, HbA1c ≤ 10%, diabetes therapeutic regimen consisting of diet or no more than two hypoglycemic agents or insulin with or without one additional oral agent (usual diabetes therapy; UDT). The primary safety endpoint will test the hypothesis that the rate of all-cause serious adverse events after one year of usual diabetes therapy (UDT) plus Cycloset™ is not greater than that for UDT plus placebo by more than an acceptable margin defined as a hazard ratio of 1.5 with a secondary endpoint analysis of the difference in the rate of serious cardiovascular events, (myocardial infarction, stroke, coronary revascularization or hospitalization for

  3. 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

  4. Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial

    PubMed Central

    Borgen, Iren; Garnweidner-Holme, Lisa Maria; Jacobsen, Anne Flem; Bjerkan, Kirsti; Fayyad, Seraj; Joranger, Pål; Lilleengen, Anne Marie; Mosdøl, Annhild; Noll, Josef; Småstuen, Milada Cvancarova; Terragni, Laura; Torheim, Liv Elin

    2017-01-01

    Introduction The promotion of a healthy diet, physical activity and measurement of blood glucose levels are essential components in the care for women with gestational diabetes mellitus (GDM). Smartphones offer a new way to promote health behaviour. The main aim is to investigate if the use of the Pregnant+ app, in addition to standard care, results in better blood glucose levels compared with current standard care only, for women with GDM. Methods and analysis This randomised controlled trial will include 230 pregnant women with GDM followed up at 5 outpatient departments (OPD) in the greater Oslo Region. Women with a 2-hour oral glucose tolerance test (OGTT) ≥9 mmol/L, who own a smartphone, understand Norwegian, Urdu or Somali and are <33 weeks pregnant, are invited. The intervention group receives the Pregnant+ app and standard care. The control group receives standard care only. Block randomisation is performed electronically. Data are collected using self-reported questionnaires and hospital records. Data will be analysed according to the intention-to-treat principle. Groups will be compared using linear regression for the main outcome and χ2 test for categorical data and Student's t-test or Mann-Whitney-Wilcoxon test for skewed distribution. The main outcome is the glucose level measured at the 2-hour OGTT 3 months postpartum. Secondary outcomes are a change in health behaviour and knowledge about GDM, quality of life, birth weight, mode of delivery and complications for mother and child. Ethics and dissemination The study is exempt from regional ethics review due to its nature of quality improvement in patient care. Our study has been approved by the Norwegian Social Science Data Services and the patient privacy protections boards governing over the recruitment sites. Findings will be presented in peer-reviewed journals and at conferences. Trial registration number NCT02588729, Post-results. PMID:28348183

  5. Evaluation of wound healing in diabetic foot ulcer using platelet-rich plasma gel: A single-arm clinical trial.

    PubMed

    Mohammadi, Mohammad Hossein; Molavi, Behnam; Mohammadi, Saeed; Nikbakht, Mohsen; Mohammadi, Ashraf Malek; Mostafaei, Shayan; Norooznezhad, Amir Hossein; Ghorbani Abdegah, Ali; Ghavamzadeh, Ardeshir

    2016-11-02

    The aim of the present study was to evaluate the effectiveness of using autologous platelet-rich plasma (PRP) gel for treatment of diabetic foot ulcer (DFU) during the first 4 weeks of the treatment. In this longitudinal and single-arm trial, 100 patients were randomly selected after meeting certain inclusion and exclusion criteria; of these 100 patients, 70 (70%) were enrolled in the trial. After the primary care actions such as wound debridement, the area of each wound was calculated and recorded. The PRP therapy (2mL/cm(2) of ulcers) was performed weekly until the healing time for each patient. We used one sample T-test for healing wounds and Bootstrap resampling approach for reporting confidence interval with 1000 Bootstrap samples. The p-value<0.05 were considered statistically significant. The mean (SD) of DFU duration was 19.71 weeks (4.94) for units sampling. The ratio of subjects who withdrew from the study was calculated to be 2 (2.8%). Average area of 71 ulcers in the mentioned number of cases was calculated to be 6.11cm(2) (SD: 4.37). Also, the mean, median (SD) of healing time was 8.7, 8 weeks (SD: 3.93) except for 2 mentioned cases. According to one sample T-test, wound area (cm(2)), on average, significantly decreased to 51.9% (CI: 46.7-57.1) through the first four weeks of therapy. Furthermore, significant correlation (0.22) was not found between area of ulcers and healing duration (p-value>0.5). According to the results, PRP could be considered as a candidate treatment for non-healing DFUs as it may prevent future complications such as amputation or death in this pathological phenomenon.

  6. Regional differences in milk and complementary feeding patterns in infants participating in an international nutritional type 1 diabetes prevention trial.

    PubMed

    Nucci, Anita M; Virtanen, Suvi M; Sorkio, Susa; Bärlund, Sonja; Cuthbertson, David; Uusitalo, Ulla; Lawson, Margaret L; Salonen, Marja; Berseth, Carol L; Ormisson, Anne; Lehtonen, Eveliina; Savilahti, Erkki; Becker, Dorothy J; Dupré, John; Krischer, Jeffrey P; Knip, Mikael; Åkerblom, Hans K

    2016-10-07

    Differences in breastfeeding, other milk feeding and complementary feeding patterns were evaluated in infants at increased genetic risk with and without maternal type 1 diabetes (T1D). The Trial to Reduce IDDM in the Genetically at Risk is an international nutritional primary prevention double-blinded randomized trial to test whether weaning to extensively hydrolyzed vs. intact cow's milk protein formula will decrease the development of T1D-associated autoantibodies and T1D. Infant diet was prospectively assessed at two visits and seven telephone interviews between birth and 8 months. Countries were grouped into seven regions: Australia, Canada, Northern Europe, Southern Europe, Central Europe I, Central Europe II and the United States. Newborn infants with a first-degree relative with T1D and increased human leukocyte antigen-conferred susceptibility to T1D were recruited. A lower proportion of infants born to mothers with than without T1D were breastfed until 6 months of age in all regions (range, 51% to 60% vs. 70% to 80%). Complementary feeding patterns differed more by region than by maternal T1D. In Northern Europe, a higher proportion of infants consumed vegetables and fruits daily compared with other regions. Consumption of meat was more frequent in all European regions, whereas cereal consumption was most frequent in Southern Europe, Canada and the United States. Maternal T1D status was associated with breastfeeding and other milk feeding patterns similarly across regions but was unrelated to the introduction of complementary foods. Infant feeding patterns differed significantly among regions and were largely inconsistent with current recommended guidelines.

  7. Effect of mobile reminders on screening yield during opportunistic screening for type 2 diabetes mellitus in a primary health care setting: A randomized trial

    PubMed Central

    Kumar, Sathish; Shewade, Hemant Deepak; Vasudevan, Kavita; Durairaju, Kathamuthu; Santhi, V.S.; Sunderamurthy, Bhuvaneswary; Krishnakumari, Velavane; Panigrahi, Krishna Chandra

    2015-01-01

    Objective. We wanted to study whether mobile reminders increased follow-up for definitive tests resulting in higher screening yield during opportunistic screening for diabetes. Methods. This was a facility-based parallel randomized controlled trial during routine outpatient department hours in a primary health care setting in Puducherry, India (2014). We offered random blood glucose testing to non-pregnant non-diabetes adults with age >30 years (667 total, 390 consented); eligible outpatients (random blood glucose ≥ 6.1 mmol/l, n = 268) were requested to follow-up for definitive tests (fasting and postprandial blood glucose). Eligible outpatients either received (intervention arm, n = 133) or did not receive mobile reminder (control arm, n = 135) to follow-up for definitive tests. We measured capillary blood glucose using a glucometer to make epidemiological diagnosis of diabetes. The trial was registered with Clinical Trial Registry of India (CTRI/2014/10/005138). Results. 85.7% of outpatients in intervention arm returned for definitive test when compared to 53.3% in control arm [Relative Risk = 1.61, (0.95 Confidence Interval — 1.35, 1.91)]. Screening yield in intervention and control arm was 18.6% and 10.2% respectively. Etiologic fraction was 45.2% and number needed to screen was 11.9. Conclusion. In countries like India, which is emerging as the diabetes capital of the world, considering the wide prevalent use of mobile phones, and real life resource limited settings in which this study was carried out, mobile reminders during opportunistic screening in primary health care setting improve screening yield of diabetes. PMID:26844130

  8. 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

  9. 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

  10. 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

  11. Testing the effectiveness of a mindfulness-based intervention to reduce emotional distress in outpatients with diabetes (DiaMind): design of a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Approximately 20-40% of outpatients with diabetes experience elevated levels of emotional distress, varying from disease-specific distress to general symptoms of anxiety and depression. The patient's emotional well-being is related to other unfavorable outcomes, like reduced quality of life, sub-optimal self-care, impaired glycemic control, higher risk of complications, and increased mortality rates. The purpose of this study is to test the effectiveness of a new diabetes-specific, mindfulness-based psychological intervention. First, with regard to reducing emotional distress; second, with respect to improving quality of life, dispositional mindfulness, and self-esteem of patients with diabetes; third, with regard to self-care and clinical outcomes; finally, a potential effect modification by clinical and personality characteristics will be explored. Methods/Design The Diabetes and Mindfulness study (DiaMind) is a randomized controlled trial. Patients with diabetes with low levels of emotional well-being will be recruited from outpatient diabetes clinics. Eligible patients will be randomized to an intervention group or a wait-list control group. The intervention group will receive the mindfulness program immediately, while the control group will receive the program eight months later. The primary outcome is emotional distress (anxiety, stress, depressive symptoms), for which data will be collected at baseline, four weeks, post intervention, and after six months follow-up. In addition, self-report data will be collected on quality of life, dispositional mindfulness, self-esteem, self-care, and personality, while complications and glycemic control will be assessed from medical files and blood pressure will be measured. Group differences will be analyzed with repeated measures analysis of covariance. The study is supported by grants from the Dutch Diabetes Research Foundation and Tilburg University and has been approved by a medical ethics committee

  12. USSR Report, Military Affairs

    DTIC Science & Technology

    2007-11-02

    and 24 brigades were destroyed and taken prisoner. The Wehrmacht lost 1,600,000 soldiers and officers. According to German data , irreplaceable...health, taking psychological data into acount, and their physical and general-education preparation. In so doing, how sincere the youth are in...Hospital for Political Affairs Lt-Col Aleksey Tel’nov bade them farewell heartily. The soldiers answered: "Thanks for the help and the care. Thanks, dear military doctors!..." 11409 CSO: 1801/207 END 58

  13. Public affairs committee actions

    NASA Astrophysics Data System (ADS)

    The AGU Public Affairs Committee will create an ad hoc committee to consider possible AGU position statements concerning the effects of nuclear war.The action was taken at the May 31, 1983, meeting of the Committee at the AGU Spring Meeting in Baltimore. Present were Carroll Ann Hodges, Chairman, and members Thomas J. Ahrens, David Cauffman, Jared Cohon, Stamatios Krimigis, Robert Murphy, Raymond Roble, and George Shaw. Also attending were the current Congressional Fellow Arthur Weissman and SPR—Cosmic Rays Section Secretary Miriam Forman.

  14. 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.

  15. Supra-Earth affairs.

    PubMed

    Othman, Mazlan

    2011-02-13

    The United Nations briefly considered the issue of extra-terrestrial intelligence at the 32nd session of the General Assembly in 1977. As a result, the Office of Outer Space Affairs was tasked to prepare a document on issues related to 'messages to extra-terrestrial civilizations', but this area has not been followed through in more recent times. This discussion paper describes the United Nations' activities in the field of near-Earth objects in some detail, and suggests that this might be used as a model of how Member States could proceed with dealing with this issue in case the existence of extra-terrestrial life/intelligence is established.

  16. 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

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

    PubMed Central

    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.

    2015-01-01

    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

  18. 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.

  19. 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.

  20. The effects of soy bean flour enriched bread intake on anthropometric indices and blood pressure in type 2 diabetic women: a crossover randomized controlled clinical trial.

    PubMed

    Salari Moghaddam, Asma; Entezari, Mohammad Hassan; Iraj, Bijan; Askari, Gholamreza; Sharifi Zahabi, Elham; Maracy, Mohammad Reza

    2014-01-01

    Previous studies showed that soy bean has the potential to improve many aspects of diabetes state and provide metabolic benefits that aid in weight management. We aimed to determine the effects of soy bean flour enriched bread on anthropometric indices and blood pressure among type 2 diabetic patients. This randomized, crossover, clinical trial was performed in 30 type 2 diabetic women. There were two trial periods for 6 weeks and a wash-out period for 4 weeks. In the soy bread diet period, 120 g of soy bean flour enriched bread was consumed each day instead of the same amount of their usual bread or other cereal products. After a 4-week wash-out period, participants were crossed over for another 6 weeks. Mean (±SD) age of study participants was 45.7 ± 3.8 years. The results of our study showed no significant effects of soy bean flour enriched bread on anthropometric indices and blood pressure among diabetic patients. Despite the slight reduction in BMI, waist circumference, and percent of body fat, there were no significant differences in changes of these values between two groups. No significant changes in waist to hip ratio and blood pressure were seen.

  1. 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 Central

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

    2014-01-01

    Abstract 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. (Population Health Management 2014;17:112–120) PMID:24152055

  2. 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.

  3. 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

    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.

  4. Physical Exercise on Inflammatory Markers in Type 2 Diabetes Patients: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Melo, Luciana Costa; Dativo-Medeiros, Jaime; Menezes-Silva, Carlos Eduardo; de Sousa-Rodrigues, Célio Fernando

    2017-01-01

    Background. Type 2 diabetes mellitus (T2DM) is a serious disease associated with high morbidity and mortality. Scientific findings showed that physical exercise is an option for treatment of these patients. This study's objective is to investigate the effects of supervised aerobic and/or resistance physical training on inflammatory markers in subjects with T2DM. Methods. A systematic review was conducted on four databases, MEDLINE, CENTRAL, LILACS, and Scopus, and manual search from 21 to 30 November 2016. Randomized clinical trials involving individuals diagnosed with T2DM, who have undergone supervised training protocols, were selected in this study. Results. Eleven studies were included. Studies that evaluated control group versus aerobic exercise reported controversial results about the effectiveness of physical training in modifying C-reactive protein (CRP) and cytokine levels. The only variable analyzed by the six studies in comparison to the control group versus resistance exercise was CRP. This protein showed no significant difference between groups. Between the two modes of exercise (aerobic and resistance), only one study demonstrated that aerobic exercise was more effective in reducing CRP. Conclusion. The evidence was insufficient to prove that aerobic or resistance exercise improves systemic levels of inflammatory markers in patients with T2DM.

  5. 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.

  6. 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.

  7. 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 perspectives…

  8. 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.

  9. SMi's Conducting Clinical Trials in Europe.

    PubMed

    Jago, Charlotte

    2009-12-01

    The Conducting Clinical Trials in Europe meeting, held in London, included topics covering new developments in the field of clinical trials and recommendations on how to best conduct a trial. This conference report highlights selected presentations on the state of affairs of trials in Europe, conducting trials in emerging markets, strategies for improving trials, trial design options, peri-approval and pediatric trials, and the role of key players, such as physicians. Company perspectives from Pfizer Inc and Nycomed are also included.

  10. 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

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

    PubMed

    Su, Yong; Su, Ya-Li; Lv, Li-Fang; Wang, Li-Min; Li, Quan-Zhong; Zhao, Zhi-Gang

    2014-06-01

    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.

  12. 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

  13. 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

    2016-02-18

    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).

  14. 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

  15. 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

  16. 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

  17. Gender Diversity within the Student Affairs Profession.

    ERIC Educational Resources Information Center

    McEwen, Marylu K.; And Others

    1990-01-01

    Investigated issue of representation of women and men in student affairs profession. Preparation program data, professional association data, and perceptions of student affairs professionals demonstrated a clear shift toward greater proportions of women in student affairs. (Author/NB)

  18. 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…

  19. 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...

  20. Effects of exercise training using resistance bands on glycaemic control and strength in type 2 diabetes mellitus: a meta-analysis of randomised controlled trials.

    PubMed

    McGinley, Samantha K; Armstrong, Marni J; Boulé, Normand G; Sigal, Ronald J

    2015-04-01

    Resistance exercise using free weights or weight machines improves glycaemic control and strength in people with type 2 diabetes. Resistance band training is potentially less expensive and more accessible, but the effects of resistance band training on glycaemic control and strength in this population are not well understood. This paper aims to systematically review and meta-analyse the effect of resistance band training on haemoglobin A1c (HbA1c) and strength in adults with type 2 diabetes. Database searches were performed in August 2013 (MEDLINE, SPORTDiscus, EMBASE, and CINAHL). Reference lists of eligible articles were hand-searched for additional studies. Randomised trials evaluating the effects of resistance band training in adults with type 2 diabetes on HbA1c or objectively measured strength were selected. Baseline and post-intervention HbA1c and strength were extracted for the intervention and control groups. Details of the exercise interventions and methodological quality were collected. Seven trials met inclusion criteria. Post-intervention-weighted mean HbA1c was nonsignificantly lower in exercise groups compared to control groups [weighted mean difference (WMD) = -0.18 percentage points (-1.91 mmol/mol); P = 0.27]. Post-intervention strength was significantly higher in the exercise groups compared to the control groups in the lower extremities (WMD = 21.90 kg; P < 0.0001), but not in the upper extremities (WMD = 2.27 kg; P = 0.13) or handgrip (WMD = 1.98 kg; P = 0.46). All trials were small and had methodological limitations. Resistance band training did not significantly affect HbA1c, upper extremity, or handgrip strength but significantly increased the strength of the lower extremities in people with type 2 diabetes.

  1. 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

  2. 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

  3. 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

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

    PubMed Central

    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.

    2016-01-01

    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 6 months. 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

  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. 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.

  7. 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.

  8. 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

  9. 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

  10. First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--Chapter 6: patient selection for pilot clinical trials of islet xenotransplantation.

    PubMed

    Hering, Bernhard J; O'Connell, Philip J

    2016-01-01

    Patients in whom type 1 diabetes is complicated by impaired awareness of hypoglycemia and recurrent episodes of severe hypoglycemia are candidates for islet or pancreas transplantation if severe hypoglycemia persists after completion of a structured stepped care approach or a formalized medical optimization run-in period that provides access to hypoglycemia-specific education including behavioral therapies, insulin analogs, and diabetes technologies under the close supervision of a specialist hypoglycemia service. Patients with type 1 diabetes and end-stage renal failure who cannot meet clinically appropriate glycemic goals or continue to experience severe hypoglycemia after completion of a formalized medical optimization program under the guidance of an expert diabetes care team are candidates for islet or pancreas transplantation either simultaneously with or after a previous kidney transplant. Similarly, patients with type 2 diabetes and problematic hypoglycemia or renal failure who meet these criteria are considered candidates for islet replacement. Likewise, patients with pancreatectomy-induced diabetes in whom an islet autograft was not available or deemed inappropriate are candidates for islet or pancreas transplantation if extreme glycemic lability persists despite best medical therapy. To justify participation of these transplant candidates in early-phase trials of porcine islet cell products, lack of timely access to islet or pancreas allotransplantation due to allosensitization, high islet dose requirements, or other factors, or alternatively, a more favorable benefit-risk determination associated with the xenoislet than the alloislet or allopancreas transplant must be demonstrated. Additionally, in non-uremic xenoislet recipients, the risks associated with diabetes must be perceived to be more serious than the risks associated with the xenoislet product and the rejection prophylaxis, and in xenoislet recipients with renal failure, the xenoislet product

  11. 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

  12. 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

  13. 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

  14. 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

  15. Weight-Bearing Versus Nonweight-Bearing Exercise for Persons With Diabetes and Peripheral Neuropathy: A Randomized Controlled Trial

    PubMed Central

    Mueller, Michael J.; Tuttle, Lori J.; LeMaster, Joseph W.; Strube, Michael J; McGill, Janet B.; Hastings, Mary K.; Sinacore, David R.

    2013-01-01

    Objective To determine the effects of weight-bearing (WB) versus nonweight-bearing (NWB) exercise for persons with diabetes mellitus (DM) and peripheral neuropathy (PN). Design Randomized controlled trial with evaluations at baseline and after intervention. Setting University-based physical therapy research clinic. Participants Participants with DM and PN (N=29) (mean age ± SD, 64.5±12.5y; mean body mass index [kg/m2] ± SD, 35.5±7.3) were randomly assigned to WB (n=15) and NWB (n=14) exercise groups. All participants (100%) completed the intervention and follow-up evaluations. Interventions Group-specific progressive balance, flexibility, strengthening, and aerobic exercise conducted sitting or lying (NWB) or standing and walking (WB) occurred 3 times a week for 12 weeks. Main Outcome Measures Measures included the 6-minute walk distance (6MWD) and daily step counts. Secondary outcome measures represented domains across the International Classification of Functioning, Disability and Health. Results The WB group showed greater gains than the NWB group over time on the 6MWD and average daily step count (P<.05). The mean and 95% confidence intervals (CIs) between-group difference over time was 29m (95% CI, 6–51) for the 6MWD and 1178 (95% CI, 150–2205) steps for the average daily step count. The NWB group showed greater improvements than the WB group over time in hemoglobin A1c values (P<.05). Conclusions The results of this study indicate the ability of this population with chronic disease to increase 6MWD and daily step count with a WB exercise program compared with an NWB exercise program. PMID:23276801

  16. Intravitreal diclofenac versus intravitreal bevacizumab in naive diabetic macular edema: a randomized double-masked clinical trial.

    PubMed

    Soheilian, Masoud; Karimi, Saeed; Ramezani, Alireza; Montahai, Talieh; Yaseri, Mehdi; Soheilian, Roham; Peyman, Gholam A

    2015-06-01

    The purpose of the study is to compare single injection of intravitreal diclofenac (IVD) with intravitreal bevacizumab (IVB) in the treatment of eyes with naïve diabetic macular edema (DME). In this randomized clinical trial, 57 eyes of 57 patients were randomly assigned to IVD group (30 eyes), cases who received a single intravitreal injection of diclofenac (500 μg/0.1 ml), and IVB group (27 eyes), cases who received a single intravitreal injection of bevacizumab (1.25 mg). Change in best-corrected visual acuity in logMAR at week 12 was the primary outcome measure. Secondary outcomes included changes in central macular thickness, macular leakage, and potential injection-related complications. Best-corrected visual acuity improved significantly more in the IVD group than in the IVB group (P = 0.033), from 0.57 ± 0.25 to 0.49 ± 0.31 versus 0.55 ± 0.24-0.59 ± 0.27 logMAR at 12 weeks, respectively. However, the difference of macular thickness changes was in favor of IVB, but not to a significant level. The amount of change in leakage was not significantly different between the groups either. None of the eyes, in either group, developed ocular hypertension (≥23 mmHg) or cataract progression. No important injection-related complication was observed during the study period. This study demonstrated the superiority of IVD over IVB in the treatment of naïve DME regarding functional, but not anatomical outcomes. Therefore, using IVD as an adjunct or even alternative to other treatments might enhance the functional outcomes in such cases. Further studies are warranted to confirm potential benefit of IVD observed in this study.

  17. Cost-effectiveness of ranibizumab in treatment of diabetic macular oedema (DME) causing visual impairment: evidence from the RESTORE trial

    PubMed Central

    Annemans, Lieven; Gallagher, Meghan; Hasan, Rafiq; Thomas, Simu; Gairy, Kerry; Knudsen, Martin; Onwordi, Henrietta

    2012-01-01

    Background/aims To evaluate the cost-effectiveness of ranibizumab as either monotherapy or combined with laser therapy, compared with laser monotherapy, in the treatment of diabetic macular oedema (DME) causing visual impairment from a UK healthcare payer perspective. Methods A Markov model simulated long-term outcomes and costs of treating DME in one eye (BCVA ≤75 letters) based on data from the RESTORE Phase III trial. Outcomes measured in quality-adjusted life-years (QALYs) were simulated for a 15-year time horizon based on 12-month follow-up from RESTORE and published long-term data. Costs included treatment, disease monitoring, visual impairment and blindness (at 2010 price levels). Results Ranibizumab monotherapy resulted in a 0.17 QALY gain at an incremental cost of £4191 relative to laser monotherapy, yielding an incremental cost-effectiveness ratio (ICER) of £24 028. Probabilistic sensitivity analysis showed a 64% probability of being cost-effective at a threshold of £30 000 per QALY. Combined ranibizumab and laser therapy resulted in a 0.13 QALY gain at an incremental cost of £4695 relative to laser monotherapy (ICER £36 106; 42% probability of ICER <£30 000). Conclusions Based on RESTORE 1-year follow-up data, ranibizumab monotherapy appears to be cost-effective relative to laser monotherapy, the current standard of care. Cost-effectiveness of combination therapy is less certain. Ongoing studies will further inform on disease progression and the need for additional ranibizumab treatment. PMID:22399690

  18. Adjustment of Open-Loop Settings to Improve Closed-Loop Results in Type 1 Diabetes: A Multicenter Randomized Trial

    PubMed Central

    Dassau, Eyal; Brown, Sue A.; Basu, Ananda; Pinsker, Jordan E.; Kudva, Yogish C.; Gondhalekar, Ravi; Patek, Steve; Lv, Dayu; Schiavon, Michele; Lee, Joon Bok; Dalla Man, Chiara; Hinshaw, Ling; Castorino, Kristin; Mallad, Ashwini; Dadlani, Vikash; McCrady-Spitzer, Shelly K.; McElwee-Malloy, Molly; Wakeman, Christian A.; Bevier, Wendy C.; Bradley, Paige K.; Kovatchev, Boris; Cobelli, Claudio; Zisser, Howard C.

    2015-01-01

    Context: Closed-loop control (CLC) relies on an individual's open-loop insulin pump settings to initialize the system. Optimizing open-loop settings before using CLC usually requires significant time and effort. Objective: The objective was to investigate the effects of a one-time algorithmic adjustment of basal rate and insulin to carbohydrate ratio open-loop settings on the performance of CLC. Design: This study reports a multicenter, outpatient, randomized, crossover clinical trial. Patients: Thirty-seven adults with type 1 diabetes were enrolled at three clinical sites. Interventions: Each subject's insulin pump settings were subject to a one-time algorithmic adjustment based on 1 week of open-loop (i.e., home care) data collection. Subjects then underwent two 27-hour periods of CLC in random order with either unchanged (control) or algorithmic adjusted basal rate and carbohydrate ratio settings (adjusted) used to initialize the zone-model predictive control artificial pancreas controller. Subject's followed their usual meal-plan and had an unannounced exercise session. Main Outcomes and Measures: Time in the glucose range was 80–140 mg/dL, compared between both arms. Results: Thirty-two subjects completed the protocol. Median time in CLC was 25.3 hours. The median time in the 80–140 mg/dl range was similar in both groups (39.7% control, 44.2% adjusted). Subjects in both arms of CLC showed minimal time spent less than 70 mg/dl (median 1.34% and 1.37%, respectively). There were no significant differences more than 140 mg/dL. Conclusions: A one-time algorithmic adjustment of open-loop settings did not alter glucose control in a relatively short duration outpatient closed-loop study. The CLC system proved very robust and adaptable, with minimal (<2%) time spent in the hypoglycemic range in either arm. PMID:26204135

  19. Mobile App-Based Interventions to Support Diabetes Self-Management: A Systematic Review of Randomized Controlled Trials to Identify Functions Associated with Glycemic Efficacy

    PubMed Central

    Wu, Yuan; Yao, Xun; Vespasiani, Giacomo; Nicolucci, Antonio; Dong, Yajie; Kwong, Joey; Li, Ling; Sun, Xin

    2017-01-01

    Background Mobile health apps for diabetes self-management have different functions. However, the efficacy and safety of each function are not well studied, and no classification is available for these functions. Objective The aims of this study were to (1) develop and validate a taxonomy of apps for diabetes self-management, (2) investigate the glycemic efficacy of mobile app-based interventions among adults with diabetes in a systematic review of randomized controlled trials (RCTs), and (3) explore the contribution of different function to the effectiveness of entire app-based interventions using the taxonomy. Methods We developed a 3-axis taxonomy with columns of clinical modules, rows of functional modules and cells of functions with risk assessments. This taxonomy was validated by reviewing and classifying commercially available diabetes apps. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Chinese Biomedical Literature Database, and ClinicalTrials.gov from January 2007 to May 2016. We included RCTs of adult outpatients with diabetes that compared using mobile app-based interventions with usual care alone. The mean differences (MDs) in hemoglobin A1c (HbA1c) concentrations and risk ratios of adverse events were pooled using a random-effects meta-analysis. After taxonomic classification, we performed exploratory subgroup analyses of the presence or absence of each module across the included app-based interventions. Results Across 12 included trials involving 974 participants, using app-based interventions was associated with a clinically significant reduction of HbA1c (MD 0.48%, 95% CI 0.19%-0.77%) without excess adverse events. Larger HbA1c reductions were noted among patients with type 2 diabetes than those with type 1 diabetes (MD 0.67%, 95% CI 0.30%-1.03% vs MD 0.36%, 95% CI 0.08%-0.81%). Having a complication prevention module in app-based interventions was associated with a greater HbA1c reduction (with complication

  20. Evaluating the Effect of Web-Based Iranian Diabetic Personal Health Record App on Self-Care Status and Clinical Indicators: Randomized Controlled Trial

    PubMed Central

    2016-01-01

    Background There are 4 main types of chronic or noncommunicable diseases. Of these, diabetes is one of the major therapeutic concerns globally. Moreover, Iran is among the countries with the highest incidence of diabetic patients. Furthermore, library-based studies by researchers have shown that thus far no study has been carried out to evaluate the relationship between Web-based diabetic personal health records (DPHR) and self-care indicators in Iran. Objective The objective of this study is to examine the effect of Web-based DPHR on self-care status of diabetic patients in an intervention group as compared with a control group. Methods The effect of DPHR on self-care was assessed by using a randomized controlled trial (RCT) protocol for a 2-arm parallel group with a 1:1 allocation ratio. During a 4-month trial period, the control group benefited from the routine care; the intervention group additionally had access to the Web-based DPHR app besides routine care. During the trial, 2 time points at baseline and postintervention were used to evaluate the impact of the DPHR app. A sample size of 72 people was randomly and equally assigned to both the control and intervention groups. The primary outcome measure was the self-care status of the participants. Results Test results showed that the self-care status in the intervention group in comparison with the control group had a significant difference. In addition, the dimensions of self-care, including normal values, changes trend, the last measured value, and the last time measured values had a significant difference while other dimensions had no significant difference. Furthermore, we found no correlation between Web-based DPHR system and covariates, including scores of weight, glycated hemoglobin (HbA1c), serum creatinine, high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, and planned visit adherence, as well as the change trend of mean for blood glucose and blood pressure. Conclusions

  1. Comparison of community health worker-led diabetes medication decision-making support for low-income Latino and African American adults with diabetes using e-Health tools versus print materials: A randomized controlled trial

    PubMed Central

    Heisler, Michele; Choi, Hwajung; Palmisano, Gloria; Mase, Rebecca; Richardson, Caroline; Fagerlin, Angela; Montori, Victor M.; Spencer, Michael; An, Laurence C.

    2015-01-01

    Background Health care centers serving low-income communities have scarce resources to support medication decision-making among patients with poorly controlled diabetes. Objective We compared outcomes between community health worker (CHW) use of a tailored, interactive web-based tablet-delivered tool (iDecide) versus use of print educational materials. Design A randomized two-arm trial from 2011-2013. Trial Registration NCT01427660. Setting Community health center in Detroit serving a Latino and African American low-income population. Participants 188 adults with a hemoglobinA1c >7.5% (55%) or who reported questions, concerns, or difficulty taking diabetes medications Primary Funding Sources Agency for Health Care Quality and Research (1R18HS019256-01) and P30DK092926 (MCDTR) Measurements Primary outcomes were changes in knowledge about anti-hyperglycemic medications, patient-reported medication decisional conflict, and satisfaction with anti-hyperglycemic medication information. We also examined changes in diabetes distress, self-efficacy, medication adherence, and A1c. Intervention Participants were randomized to receive a 1-2 hour session with a CHW using either iDecide or printed educational materials and two follow-up calls. Results 94% of participants completed three-month follow-up. Both groups improved across most measures. iDecide participants reported greater improvements in satisfaction with medication information (helpfulness, p=.007; clarity, p=.03) and in diabetes distress compared to the print materials group (p<0.001). There were no differences between groups in other outcomes. Limitations The study was conducted at one health center over a short period, and the CHWs were experienced in behavioral counseling, thus possibly mitigating the need for additional support tools. Conclusions Most outcomes were similarly improved among participants receiving both types of diabetes medication decision-making support. Longer-term evaluations are necessary to

  2. 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

  3. 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

  4. A meta-synthesis of behavioral outcomes from telemedicine clinical trials for type 2 diabetes and the Clinical User-Experience Evaluation (CUE).

    PubMed

    Jalil, Sakib; Myers, Trina; Atkinson, Ian

    2015-03-01

    A worldwide demographic shift is in progress and the aged population proportion is projected to more than double across the next four decades. Our current healthcare models may not be adequate to handle this shift in demography, which may have serious consequences for the ageing population who are more prone to chronic diseases. One proposed remediation is to provide in-home assisted healthcare with technology-intervened approaches. Telemedicine, telehealth, e-health are paradigms found in scientific literature that provide clinical treatment through a technology intervention. In evidence-based medical science, these technology interventions are evaluated through clinical trials, which are targeted to measure improvements in medical conditions and the treatment's cost effectiveness. However, effectiveness of a technology also depends on the interaction pattern between the technology and its' users, especially the patients. This paper presents (1) a meta-synthesis of clinical trials for technology-intervened treatments of type 2 diabetes and (2) the Clinical User-Experience Evaluation (CUE). CUE is a recommendation for future telemedicine clinical trials that focuses on the patient as the user from Human-Computer Interaction (HCI) perspective and was developed as part of this research. The clinical trials reviewed were interpreted from a technology perspective and the non-medical or non-biological improvements of the users (patients) rather than the medical outcome. Results show that technology-intervened treatments provide positive behavior changes among patients and are potentially highly beneficial for chronic illness management such as type 2 diabetes. The results from the CUE method show how it complements clinical trials to capture patients' interaction with a technology.

  5. Effects of dipeptidyl peptidase-4 inhibitors on beta-cell function and insulin resistance in type 2 diabetes: meta-analysis of randomized controlled trials

    PubMed Central

    Lyu, Xiafei; Zhu, Xiaolin; Zhao, Bin; Du, Liang; Chen, Dawei; Wang, Chun; Liu, Guanjian; Ran, Xingwu

    2017-01-01

    Dipeptidyl peptidase-4 (DPP-4) inhibitors are a novel family of glucose-lowering agents. Accumulating evidence suggests that DPP-4 inhibitors preserve pancreatic beta-cell function, but results in previous studies have been inconsistent. We assessed the effects of DPP-4 inhibitors on the homoeostasis model assessment beta-cell function (HOMA-B) or insulin resistance (HOMA-IR) index in patients with type 2 diabetes through a systematic review and meta-analysis of randomized controlled trials (RCTs). Relevant articles were identified from PubMed, Embase, and Cochrane Library databases up to December 27, 2016. We calculated weighted mean differences (WMDs) and 95% confidence intervals (CIs) in each included trial and pooled the data using a random-effects model. Fifty-two trials were included in the present analysis. Compared with placebo control, DPP-4 inhibitors as monotherapy significantly improved HOMA-B (WMD 9.15; 95% CI 7.48, 10.81). Similarly, DPP-4 inhibitors as add-on therapy in combination with other drugs showed significant improvement in HOMA-B (WMD 9.04; 95% CI 5.72, 12.37). However, we found no significant improvement in HOMA-IR following treatment with DPP-4 inhibitors as mono-therapy or as add-on therapy. In conclusion, DPP-4 inhibitors as monotherapy or as add-on therapy significantly improved beta-cell function but had no significant effect on insulin resistance in type 2 diabetes. PMID:28322294

  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.

  7. CLOCK gene variation is associated with incidence of type-2 diabetes and cardiovascular diseases in type-2 diabetic subjects: dietary modulation in the PREDIMED randomized trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Background Circadian rhythms regulate key biological processes influencing metabolic pathways. Dysregulation is associated with type 2 diabetes (T2D) and cardiovascular diseases (CVD). Circadian rhythms are generated by a transcriptional autoregulatory feedback loop involving core clock genes. CLOCK...

  8. A Multifunctional Bread Rich in Beta Glucans and Low in Starch Improves Metabolic Control in Type 2 Diabetes: A Controlled Trial

    PubMed Central

    Tessari, Paolo; Lante, Anna

    2017-01-01

    Design: Functional foods may be useful for people with diabetes. The soluble fibers beta glucans can modify starch digestion and improve postprandial glucose response. We analyzed the metabolic effects of a specifically designed ‘functional’ bread, low in starch, rich in fibers (7 g/100 g), with a beta glucan/starch ratio of (7.6:100, g/g), in people with type 2 diabetes mellitus. Methods: Clinical and metabolic data from two groups of age-, sex- and glycated hemoglobin-matched diabetic subjects, taking either the functional bread or regular white bread, over a roughly six-month observation period, were retrieved. Results: Bread intake did not change during the trial. The functional bread reduced glycated hemoglobin by ~0.5% (absolute units) vs. pre-treatment values (p = 0.028), and by ~0.6% vs. the control group (p = 0.027). Post-prandial and mean plasma glucose was decreased in the treatment group too. Body weight, blood pressure and plasma lipids did not change. The acceptance of the functional bread was good in the majority of subjects, except for taste. Conclusions: A starch-restricted, fiber-rich functional bread, with an increased beta glucan/starch ratio, improved long term metabolic control, and may be indicated in the dietary treatment of type 2 diabetes. PMID:28304350

  9. Activation of heat shock response to treat obese subjects with type 2 diabetes: a prospective, frequency-escalating, randomized, open-label, triple-arm trial

    PubMed Central

    Kondo, Tatsuya; Goto, Rieko; Ono, Kaoru; Kitano, Sayaka; Suico, Mary Ann; Sato, Miki; Igata, Motoyuki; Kawashima, Junji; Motoshima, Hiroyuki; Matsumura, Takeshi; Kai, Hirofumi; Araki, Eiichi

    2016-01-01

    Activation of heat shock response (HSR) improves accumulated visceral adiposity and metabolic abnormalities in type 2 diabetes. To identify the optimal intervention strategy of the activation of the HSR provided by mild electrical stimulation (MES) with heat shock (HS) in type 2 diabetes. This study was a prospective, frequency-escalating, randomized, open-label, triple-arm trial in Japan. A total of 60 obese type 2 diabetes patients were randomized into three groups receiving two, four, or seven treatments per week for 12 weeks. No adverse events were identified. MES + HS treatment (when all three groups were combined), significantly improved visceral adiposity, glycemic control, insulin resistance, systemic inflammation, renal function, hepatic steatosis and lipid profile compared to baseline. The reduction in HbA1c was significantly greater among those treated four times per week (−0.36%) or seven times per week (−0.65%) than among those treated two times per week (−0.10%). The relative HbA1c levels in seven times per week group was significantly decreased when adjusted by two times per week group (−0.55%. p = 0.001). This research provides the positive impact of MES + HS to treat obese patients with type 2 diabetes mellitus. PMID:27759092

  10. The Feasibility of Health Trainer Improved Patient Self-Management in Patients with Low Health Literacy and Poorly Controlled Diabetes: A Pilot Randomised Controlled Trial

    PubMed Central

    Rathod, Trishna; Rowlands, Gillian; Richardson, Gerry; Reeves, David

    2016-01-01

    Type 2 diabetes mellitus is most prevalent in deprived communities and patients with low health literacy have worse glycaemic control and higher rates of diabetic complications. However, recruitment from this patient population into intervention trials is highly challenging. We conducted a study to explore the feasibility of recruitment and to assess the effect of a lay health trainer intervention, in patients with low health literacy and poorly controlled diabetes from a socioeconomically disadvantaged population, compared with usual care. Methods. A pilot RCT comparing the LHT intervention with usual care. Patients with HbA1c > 7.5 (58 mmol/mol) were recruited. Baseline and 7-month outcome data were entered directly onto a laptop to reduce patient burden. Results. 76 patients were recruited; 60.5% had low health literacy and 75% were from the most deprived areas of England. Participants in the LHT arm had significantly improved mental health (p = 0.049) and illness perception (p = 0.040). The intervention was associated with lower resource use, better patient self-care management, and better QALY profile at 7-month follow-up. Conclusion. This study describes successful recruitment strategies for hard-to-reach populations. Further research is warranted for this cost-effective, relatively low-cost intervention for a population currently suffering a disproportionate burden of diabetes, to demonstrate its sustained impact on treatment effects, health, and health inequalities. PMID:27833922

  11. 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.

  12. The clinical investigation of Citrullus colocynthis (L.) schrad fruit in treatment of Type II diabetic patients: a randomized, double blind, placebo-controlled clinical trial.

    PubMed

    Huseini, H Fallah; Darvishzadeh, F; Heshmat, R; Jafariazar, Z; Raza, Mohsin; Larijani, B

    2009-08-01

    Citrullus colocynthis (L.) Schrad fruit is an herbal medicine used by traditional herbalists for the treatment of diabetes in Iran. To determine its efficacy and toxicity, a 2 month clinical trial was conducted in 50 type II diabetic patients. Two groups of 25 each under standard antidiabetic therapy, received 100 mg C. colocynthis fruit capsules or placebos three times a day, respectively. The patients were visited monthly and glycosylated hemoglobin (HbA1c), fasting blood glucose, total cholesterol, LDL, HDL, triglyceride, aspartate transaminase, alanine transaminase, alkaline phosphatase, urea and creatinine levels were determined at the beginning and after 2 months. The results showed a significant decrease in HbA1c and fasting blood glucose levels in C. colocynthis treated patients. Other serological parameters levels in both the groups did not change significantly. No notable gastrointestinal side effect was observed in either group. In conclusion, C. colocynthis fruit treatment had a beneficial effect on improving the glycemic profile without severe adverse effects in type II diabetic patients. Further clinical studies are recommended to evaluate the long-term efficacy and toxicity of C. colocynthis in diabetic patients.

  13. [Voglibose for the prevention of type 2 diabetes mellitus: a randomised, double-blind trial in Japanese subjects with impaired glucose tolerance].

    PubMed

    Kawamori, Ryuzo

    2010-05-01

    The study to assess whether voglibose could prevent type 2 diabetes developing in high-risk Japanese subjects with impaired glucose tolerance (IGT) were performed. This was a multicenter, randomised, double-blind, parallel group trial comparing voglibose 0.2 mg three times a day and corresponding placebo. 1,780 eligible subjects received standard diet and exercise therapy, and 897 were randomised to receive voglibose and 883 placebo. The study was planned for treatment to be continued until participants developed type 2 diabetes[primary endpoint; determined by bi-annual oral glucose tolerance tests (OGTTs) as well as fasting blood glucose measured every 3 months] or normalisation of the OGTT or for a minimum of 3 years, subject to the findings of an interim analysis. The interim analysis significantly favoured voglibose and this end-of-study report involves individuals treated for an average of 48.1 weeks. Subjects treated with voglibose had a significantly lower risk for the progression to type 2 diabetes than placebo (50/897 vs 106/881: hazard ratio 0.595). Also, significantly more subjects in the voglibose group achieved a normal OGTT compared with those in the placebo group (599/897 vs 454/881: hazard ratio 1.539). Voglibose, in addition to standard care with diet and exercise, was effective in preventing the progression of IGT to type 2 diabetes and in facilitating the normalisation of the OGTT in high-risk Japanese subjects with IGT.

  14. 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

  15. Lifestyle weight-loss intervention outcomes in overweight and obese adults with type 2 diabetes: a systematic review and meta-analysis of randomized clinical trials.

    PubMed

    Franz, Marion J; Boucher, Jackie L; Rutten-Ramos, Stephanie; VanWormer, Jeffrey J

    2015-09-01

    The majority of people with type 2 diabetes are overweight or obese, and weight loss is a recommended treatment strategy. A systematic review and meta-analysis was undertaken to answer the following primary question: In overweight or obese adults with type 2 diabetes, what are the outcomes on hemoglobin A1c (HbA1c) from lifestyle weight-loss interventions resulting in weight losses greater than or less than 5% at 12 months? Secondary questions are: What are the lipid (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides) and blood pressure (systolic and diastolic) outcomes from lifestyle weight-loss interventions resulting in weight losses greater than or less than 5% at 12 months? And, what are the weight and metabolic outcomes from differing amounts of macronutrients in weight-loss interventions? Inclusion criteria included randomized clinical trial implementing weight-loss interventions in overweight or obese adults with type 2 diabetes, minimum 12-month study duration, a 70% completion rate, and an HbA1c value reported at 12 months. Eleven trials (eight compared two weight-loss interventions and three compared a weight-loss intervention group with a usual care/control group) with 6,754 participants met study criteria. At 12 months, 17 study groups (8 categories of weight-loss intervention) reported weight loss <5% of initial weight (-3.2 kg [95% CI: -5.9, -0.6]). A meta-analysis of the weight-loss interventions reported nonsignificant beneficial effects on HbA1c, lipids, or blood pressure. Two study groups reported a weight loss of ≥5%: a Mediterranean-style diet implemented in newly diagnosed adults with type 2 diabetes and an intensive lifestyle intervention implemented in the Look AHEAD (Action for Health in Diabetes) trial. Both included regular physical activity and frequent contact with health professionals and reported significant beneficial effects on HbA1c, lipids, and blood pressure. Five

  16. Reflections on using non-inferiority randomised placebo controlled trials in assessing cardiovascular safety of new agents for treatment of type 2 diabetes.

    PubMed

    Campbell-Scherer, Denise

    2017-04-01

    The 2008 Food and Drug Administration (FDA) guidance to industry requires experimental evidence that new agents to treat type 2 diabetes do not have an unacceptable increase in cardiovascular risk. They specify this unacceptable increase to be a risk ratio of 1.3 in non-inferiority trials which may use placebo control. Clinically, this means that if a new agent achieves this threshold of not being 30% worse than placebo it is declared 'non-inferior'. This guidance was in response to safety concerns raised about medications approved on their basis of reducing glycated haemoglobin alone. There was concern that this FDA guidance would stifle new drugs coming to market. On the contrary, there have been a number of exciting new classes of agents approved with improved confidence that they reduce glycated haemoglobin, and that they also do not excessively increase cardiovascular risk. Cardiovascular safety trials have been conducted for a number of novel medications using a non-inferiority approach. However, clinicians need to recognise that the results of non-inferiority trials are not as credible as superiority trials. It is important to closely review the trials before accepting claims of 'non-inferiority' or 'cardiac neutrality' especially when these studies are often compared with placebo, and may be accepting estimates of effect which span potentially clinically meaningful harm. There are compelling reasons to further investigate agents showing promise in non-inferiority trials with superiority trials, which include prespecified subgroups, and with sufficient power and duration to provide robust estimates of harms and benefits to inform clinical decision-making.

  17. Understanding the Quality Chasm for Hypertension Control in Diabetes: A Structured Review of “Co-maneuvers” Used in Clinical Trials

    PubMed Central

    Naik, Aanand D.; Issac, Tim T.; Street, Richard L.; Kunik, Mark E.

    2010-01-01

    Background Observational studies routinely describe a significant gap between rates of blood pressure control in routine diabetes care compared with those achieved in randomized controlled trials (RCTs). Methods We performed a systematic review of the literature to identify co-maneuvers used in RCTs, defined as ancillary activities or agents administered before, during, or immediately after the main agent under investigation (ie, principal maneuver), but not effectively translated to routine diabetes care. We searched multiple databases for RCTs evaluating the efficacy of treatments for hypertension control in adults with type 2 diabetes mellitus. We considered only phase III human studies of interventions that achieved blood pressure control and scrutinized all elements related to the implementation of the principal maneuver in each candidate study. These elements were then sorted into a taxonomy of co-maneuvers. Results Nearly all eligible RCTs used highly consistent groups of co-maneuvers. These typically began with (1) the use of consensual and clearly stated blood pressure goals; (2) frequent visits in which blood pressure levels were measured and compared with predefined goals; and, if the goal was not attained, (3) modifications to the treatment based on a detailed action plan that included communication of adverse events. Patient education, feedback to clinicians, and interventions for medication adherence were not commonly used among eligible trials. Conclusions Clinicians should translate key behavioral co-maneuvers along with clinically proven treatments for hypertension control in diabetes. These co-maneuvers are conceptually similar to collaborative goal setting and action planning interventions used in innovative chronic care programs. PMID:17823464

  18. Effects of high-protein diets on body weight, glycaemic control, blood lipids and blood pressure in type 2 diabetes: meta-analysis of randomised controlled trials.

    PubMed

    Dong, Jia-Yi; Zhang, Zeng-Li; Wang, Pei-Yu; Qin, Li-Qiang

    2013-09-14

    High-protein diets are popular for weight management, but the health effects of such diets in diabetic persons are inconclusive. The aim of the present meta-analysis was to examine the effects of high-protein diets on body weight and metabolic risk factors in patients with type 2 diabetes. We searched the PubMed and Cochrane Library databases for relevant randomised trials up to August 2012. Either a fixed- or a random-effects model was used to combine the net changes in each outcome from baseline to the end of the intervention. Overall, nine trials including a total of 418 diabetic patients met our inclusion criteria. The study duration ranged from 4 to 24 weeks. The actual intake of dietary protein ranged from 25 to 32% of total energy in the intervention groups and from 15 to 20% in the control groups. Compared with the control diets, high-protein diets resulted in more weight loss (pooled mean difference: 22.08, 95% CI 23.25, 20.90 kg). High-protein diets significantly decreased glycated Hb A1C (HbA1C) levels by 0.52 (95% CI 20.90, 20.14) %, but did not affect the fasting blood glucose levels. There were no differences in lipid profiles. The pooled net changes in systolic and diastolic blood pressure were 23.13 (95% CI 26.58, 0.32)mmHg and 21.86 (95% CI 24.26, 0.56) mmHg, respectively. However, two studies reported a large influence on weight loss and HbA1C levels, respectively. In summary, high-protein diets (within 6 months) may have some beneficial effects on weight loss, HbA1C levels and blood pressure in patients with type 2 diabetes. However, further investigations are still required to draw a conclusion.

  19. 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

  20. Hypotheses, rationale, design, and methods for prognostic evaluation in type 2 diabetic patients with angiographically normal coronary arteries. The MASS IV-DM Trial

    PubMed Central

    2010-01-01

    Background The MASS IV-DM Trial is a large project from a single institution, the Heart Institute (InCor), University of São Paulo Medical School, Brazil to study ventricular function and coronary arteries in patients with type 2 diabetes mellitus. Methods/Design The study will enroll 600 patients with type 2 diabetes who have angiographically normal ventricular function and coronary arteries. The goal of the MASS IV-DM Trial is to achieve a long-term evaluation of the development of coronary atherosclerosis by using angiograms and coronary-artery calcium scan by electron-beam computed tomography at baseline and after 5 years of follow-up. In addition, the incidence of major cardiovascular events, the dysfunction of various organs involved in this disease, particularly microalbuminuria and renal function, will be analyzed through clinical evaluation. In addition, an effort will be made to investigate in depth the presence of major cardiovascular risk factors, especially the biochemical profile, metabolic syndrome inflammatory activity, oxidative stress, endothelial function, prothrombotic factors, and profibrinolytic and platelet activity. An evaluation will be made of the polymorphism as a determinant of disease and its possible role in the genesis of micro- and macrovascular damage. Discussion The MASS IV-DM trial is designed to include diabetic patients with clinically suspected myocardial ischemia in whom conventional angiography shows angiographically normal coronary arteries. The result of extensive investigation including angiographic follow-up by several methods, vascular reactivity, pro-thrombotic mechanisms, genetic and biochemical studies may facilitate the understanding of so-called micro- and macrovascular disease of DM. PMID:20920271

  1. Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder

    PubMed Central

    Schneider, Kristin L.; Pagoto, Sherry L.; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S.; Ma, Yunsheng

    2011-01-01

    Background The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. Methods/Design Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. Discussion A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. Trial registration NCT01024790 PMID:21765864

  2. Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder.

    PubMed

    Schneider, Kristin L; Pagoto, Sherry L; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S; Ma, Yunsheng

    2011-06-01

    BACKGROUND: The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. METHODS/DESIGN: Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. DISCUSSION: A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. TRIAL REGISTRATION: NCT01024790.

  3. Effects of lixisenatide on elevated liver transaminases: systematic review with individual patient data meta-analysis of randomised controlled trials on patients with type 2 diabetes

    PubMed Central

    Gluud, Lise L; Knop, Filip K; Vilsbøll, Tina

    2014-01-01

    Objective To evaluate the effects of the glucagon-like peptide-1 receptor agonist lixisenatide on elevated liver blood tests in patients with type 2 diabetes. Design Systematic review. Data sources Electronic and manual searches were combined. Study selection Randomised controlled trials (RCTs) on lixisenatide versus placebo or active comparators for type 2 diabetes were included. Participants Individual patient data were retrieved to calculate outcomes for patients with elevated liver blood tests. Main outcome measures Normalisation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Data synthesis The results of included trials were combined in meta-analyses. Sequential, subgroup and regression analyses were performed to evaluate heterogeneity and bias. Results We included 12 RCTs on lixisenatide versus placebo and 3 RCTs with the active comparators liraglutide, exenatide or sitagliptin. The mean treatment duration was 29 weeks. Lixisenatide increased the proportion of patients with normalisation of ALT (risk difference: 0.07; 95% CI 0.01 to 0.14; number needed to treat: 14 patients, p=0.042). The effect was not confirmed in sequential analysis. No effects of lixisenatide were identified on AST, alkaline phosphatase or bilirubin. No evidence of bias was identified. Mixed effect multilevel meta-regression analyses suggest that the benefit of lixisenatide on ALT was limited to patients who were overweight or obese. Conclusions This review suggests that lixisenatide increases the proportion of obese or overweight patients with type 2 diabetes who achieve normalisation of ALT. Additional research is needed to determine if the findings translate to clinical outcome measures. Trial registration number PROSPERO; CRD42013005779. PMID:25526792

  4. 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.

  5. 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

  6. Cross-sectional associations between dietary intake and carotid intima media thickness in type 2 diabetes: baseline data from a randomised trial

    PubMed Central

    Chiavaroli, Laura; Mirrahimi, Arash; Ireland, Christopher; Mitchell, Sandra; Sahye-Pudaruth, Sandhya; Coveney, Judy; Olowoyeye, Omodele; Patel, Darshna; de Souza, Russell J; Augustin, Livia S A; Bashyam, Balachandran; Pichika, Sathish Chandra; Blanco Mejia, Sonia; Nishi, Stephanie K; Leiter, Lawrence A; Josse, Robert G; McKeown-Eyssen, Gail E; Moody, Alan R; Kendall, Cyril W C; Sievenpiper, John L; Jenkins, David J A

    2017-01-01

    Objective To assess associations between dietary intake and carotid intima media thickness (CIMT) by carotid ultrasound (CUS), a surrogate marker of cardiovascular disease (CVD) risk, in those with type 2 diabetes. Design Cross-sectional analysis of baseline data from 325 participants from three randomised controlled trials collected in the same way. Setting Risk Factor Modification Centre, St. Michael's Hospital, Toronto, Canada. Participants 325 participants with type 2 diabetes, taking oral antidiabetic agents, with an HbA1c between 6.5% and 8.0% at screening, without a recent cardiovascular event. Main outcome measures CIMT by CUS and associations with dietary intake from 7-day food records, as well as anthropometric measures and fasting serum samples. Results CIMT was significantly inversely associated with dietary pulse intake (β=−0.019, p=0.009), available carbohydrate (β=−0.004, p=0.008), glycaemic load (β=−0.001, p=0.007) and starch (β=−0.126, p=0.010), and directly associated with total (β=0.004, p=0.028) and saturated (β=0.012, p=0.006) fat intake in multivariate regression models adjusted for age, smoking, previous CVD event, blood pressure medication, antidiabetic medication and ultrasonographer. Conclusions Lower CIMT was significantly associated with greater consumption of dietary pulses and carbohydrates and lower total and saturated fat intake, suggesting a potential role for diet in CVD risk management in type 2 diabetes. Randomised controlled trials are anticipated to explore these associations further. Trial registration number NCT01063374. PMID:28336747

  7. 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...

  8. Practice network-based care management for patients with type 2 diabetes and multiple comorbidities (GEDIMAplus): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Care management interventions in the German health-care system have been evaluated with promising results, but further research is necessary to explore their full potential in the context of multi-morbidity. Our aim in this trial is to assess the efficacy of a primary care practice network–based care management intervention in improving self-care behaviour among patients with type 2 diabetes mellitus and multiple co-occurring chronic conditions. Methods/Design The study is designed as a prospective, 18-month, multicentre, investigator-blinded, two-arm, open-label, individual-level, randomized parallel-group superiority trial. We will enrol 582 patients with type 2 diabetes mellitus and at least two severe chronic conditions and one informal caregiver per patient. Data will be collected at baseline (T0), at the primary endpoint after 9 months (T1) and at follow-up after 18 months (T2). The primary outcome will be the differences between the intervention and control groups in changes of diabetes-related self-care behaviours from baseline to T1 using a German version of the revised Summary of Diabetes Self-Care Activities (SDSCA-G). The secondary outcomes will be the differences between the intervention and control groups in: changes in scores on the SDSCA-G subscales, glycosylated haemoglobin A level, health-related quality of life, self-efficacy, differences in (severe) symptomatic hypoglycaemia, cost-effectiveness and financial family burden. The intervention will be delivered by trained health-care assistants as an add-on to usual care and will consist of three main elements: (1) three home visits, including structured assessment of medical and social needs; (2) 24 structured telephone monitoring contacts; and (3) self-monitoring of blood glucose levels after T1 in 3-month intervals. The control group will receive usual care. The confirmatory primary analysis will be performed following the intention-to-treat (ITT) principle. The efficacy of the

  9. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 6: Patient selection for pilot clinical trials of islet xenotransplantation.

    PubMed

    O'Connell, Philip J

    2009-01-01

    Several clinical scenarios would justify trials of islet xenotransplantation, including islet after kidney (IAK) transplantation and islet xenotransplantation for hypoglycemia unawareness. In selecting a patient cohort, several factors unique to xenotransplant trials must be considered, including the potential for unique infective complications, the risks of immunosuppression, and the requirement for life-long monitoring. These factors need to be balanced against the benefits of improved glycemic control and ability to deliver large numbers of high-quality islets, something more difficult to achieve in islet allotransplantation. The importance of these risks varies depending on the patient cohort selected and proposed therapy to be undertaken. In islet xenotransplantation for hypoglycemia unawareness, immunosuppressive risks, and problems with life-long monitoring need special attention in trial design. Whereas in IAK xenotransplantation, consideration must be given to ensure that the procedure does not impact on renal allograft outcomes and patient co-morbidity, which is already significant in renal transplant recipients. This review outlines the rationale for undertaking islet xenotransplantation in highly select patients with type 1 diabetes and addresses some of the unique challenges. At present, no clear consensus exists as to the most appropriate patient group for the first trials of islet xenotransplantation. Rather, this will depend on the type of treatment being proposed, the potential infective risks and the overall burden of immunosuppression.

  10. 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

  11. 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…

  12. 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

  13. 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

  14. Remission of pre-diabetes to normal glucose tolerance in obese adults with high protein versus high carbohydrate diet: randomized control trial

    PubMed Central

    Stentz, Frankie B; Brewer, Amy; Wan, Jim; Garber, Channing; Daniels, Blake; Sands, Chris; Kitabchi, Abbas E

    2016-01-01

    Objective Remission of pre-diabetes to normal is an important health concern which has had little success in the past. This study objective was to determine the effect on remission of pre-diabetes with a high protein (HP) versus high carbohydrate (HC) diet and effects on metabolic parameters, lean and fat body mass in prediabetic, obese subjects after 6 months of dietary intervention. Research design and methods We recruited and randomized 24 pre-diabetes women and men to either a HP (30% protein, 30% fat, 40% carbohydrate; n=12) or HC (15% protein, 30% fat, 55% carbohydrate; n=12) diet feeding study for 6 months in this randomized controlled trial. All meals were provided to subjects for 6 months with daily food menus for HP or HC compliance with weekly food pick-up and weight measurements. At baseline and after 6 months on the respective diets oral glucose tolerance and meal tolerance tests were performed with glucose and insulin measurements and dual energy X-ray absorptiometry scans. Results After 6 months on the HP diet, 100% of the subjects had remission of their pre-diabetes to normal glucose tolerance, whereas only 33.3% of subjects on the HC diet had remission of their pre-diabetes. The HP diet group exhibited significant improvement in (1) insulin sensitivity (p=0.001), (2) cardiovascular risk factors (p=0.04), (3) inflammatory cytokines (p=0.001), (4) oxidative stress (p=0.001), (5) increased percent lean body mass (p=0.001) compared with the HC diet at 6 months. Conclusions This is the first dietary intervention feeding study, to the best of our knowledge, to report 100% remission of pre-diabetes with a HP diet and significant improvement in metabolic parameters and anti-inflammatory effects compared with a HC diet at 6 months. Trial registration number NCT0164284. PMID:27843552

  15. The Inclusion of Ethnic Minority Patients and the Role of Language in Telehealth Trials for Type 2 Diabetes: A Systematic Review

    PubMed Central

    Ward, Danielle; Rooshenas, Leila; Edwards, Louisa

    2016-01-01

    Background Type 2 diabetes is a serious, pervasive metabolic condition that disproportionately affects ethnic minority patients. Telehealth interventions can facilitate type 2 diabetes monitoring and prevent secondary complications. However, trials designed to test the effectiveness of telehealth interventions may underrecruit or exclude ethnic minority patients, with language a potential barrier to recruitment. The underrepresentation of minorities in trials limits the external validity of the findings for this key patient demographic. Objective This systematic review examines (1) the research reporting practices and prevalence of ethnic minority patients included in telehealth randomized controlled trials (RCTs) targeting type 2 diabetes and the trial characteristics associated with recruiting a high proportion of minority patients, and (2) the proportion of included RCTs that report using English language proficiency as a patient screening criterion and how and why they do so. Methods Telehealth RCTs published in refereed journals targeting type 2 diabetes as a primary condition for adults in Western majority English-speaking countries were included. Ethnically targeted RCTs were excluded from the main review, but were included in a post hoc subgroup analysis. Abstract and full-text screening, risk of bias assessment, and data extraction were independently conducted by two reviewers. Results Of 3358 records identified in the search, 79 articles comprising 58 RCTs were included. Nearly two-thirds of the RCTs (38/58) reported on the ethnic composition of participants, with a median proportion of 23.5% patients (range 0%-97.7%). Fourteen studies (24%) that included at least 30% minority patients were all US-based, predominantly recruited from urban areas, and described the target population as underserved, financially deprived, or uninsured. Eight of these 14 studies (57%) offered intervention materials in a language other than English or employed bilingual staff

  16. Regulation of glucose control in people with type 2 diabetes: a review and consensus.

    PubMed

    Woo, Jeong-Taek; Park, Kyung Soo; Byun, Dong-Won; Ko, Kyung Soo; Chung, Yoon-Sok; Kim, Doo Man; Park, Tae Sun; Cha, Bong Soo; Lee, In Kyu; Park, Joong Yeol; Son, Hyun Shik; Lee, Moon-Kyu; Kim, Kwang Won; Son, Ho Young

    2010-02-01

    A conference was convened by the Korean Diabetes Association and the Korean Endocrine Society on September 7, 2009 to discuss and organize the results of research on intensive glucose control for the prevention of cardiovascular disease in patients with type 2 diabetes. Professor Kyung Soo Park led the conference, and Professors Kwang Won Kim and Ho Young Son acted as chairmen. Professors Doo Man Kim, Tae Sun Park, and Bong Soo Cha reported on intensive glucose control and diabetic complications, including the UK Prospective Diabetes Study (UKPDS), Diabetes Control and Complication Trial (DCCT) research results, the recently published Action to Control Cardiovascular Risk in Diabetes (ACCORD), Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE), and Veterans Affairs Diabetes Trial (VADT) research, as well as meta-analyses. Professor Jeong-Taek Woo reported on the manuscript written by the committee for the Korean Diabetes Association which dealt with the treatment of diabetes mellitus. Professors Kyung Soo Ko, Joong Yeol Park, Hyun Shik Son, Moon-Kyu Lee, Dong-Won Byun, and Yoon-Sok Chung participated in the discussion and collected information for the manuscript from all of the participants. The aim of the debate was to determine how to establish target goals for intensive glucose control and how to individualize those goals. The participants concluded that there was no need to modify the recommendation of maintaining an HbA1c under 6.5%, the current blood glucose treatment goal that is recommended by the Korean Diabetes Association. In addition, individual target goals for glucose control were recommended depending on the situation of each patient. We report on the consensus statement from the meeting.

  17. Intravitreal Bevacizumab with or without Triamcinolone for Refractory Diabetic Macular Edema: Long-term Results of a Clinical Trial

    PubMed Central

    Shoeibi, Nasser; Ahmadieh, Hamid; Entezari, Morteza; Yaseri, Mehdi

    2013-01-01

    Purpose To report the long-term results of intravitreal bevacizumab (IVB) injection alone or combined, at the time of first IVB injection, with intravitreal triamcinolone acetonide (IVT) for treatment of refractory diabetic macular edema (DME). Methods In this randomized clinical trial, 115 eyes of 101 patients with refractory DME were enrolled and randomly assigned to one of the three study arms: the IVB group (41 eyes) received three consecutive injections of 1.25 mg IVB at 6-week intervals; the IVB/IVT group (37 eyes) additionally received 2 mg of IVT at the time of first IVB injection; and the control (sham injection) group. Patients in the IVB and IVB/IVT groups were followed for a mean of 13.3 months and received retreatment with IVB alone whenever indicated. Main outcome measures were best corrected visual acuity (BCVA) and central macular thickness (CMT). Results At the last follow up, CMT decreased significantly in the IVB group (p=0.013) but it was not significant (p=0.13) in the IVB/IVT group. Mean CMT improvement was 91 (95% CI, 20 to 161) microns and 57 (95% CI, -18 to 133) microns in the IVB and IVB/IVT groups, respectively. Mean BCVA improvement from baseline was 0.28 (95% CI, 0.18 to 0.38) logMAR (P=0.017) in the IVB group and 0.19 (95% CI, 0.08 to 0.30) logMAR (P=0.001) in the IVB/IVT group. There was no difference between the two groups in terms of visual improvment (p=0.42). In generalized linear mixed model, only the time interval between the last injection and CMT measurement was statistically significant (P=0.04). The same results were repeated for visual acuity (P=0.03). Conclusion Three loading doses of IVB (added doses if required) have long-term beneficial effects for treatment of refractory DME. Adding triamcinolone to this regimen provides no additional long-term benefit. PMID:23943683

  18. 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

  19. Effects of krill oil on endothelial function and other cardiovascular risk factors in participants with type 2 diabetes, a randomized controlled trial

    PubMed Central

    Lobraico, Jessika M; DiLello, Lauren C; Butler, Amber D; Cordisco, Marie Elena; Petrini, Joann R; Ahmadi, Ramin

    2015-01-01

    Objective The purpose of this trial was to evaluate the effect of krill oil supplementation, a source of ω-3 fatty acids, on cardiovascular disease risk factors and blood glucose control among participants with type 2 diabetes. Research design and methods A randomized, double-blind controlled cross-over trial was employed. Outcomes assessed were: endothelial function, blood lipids, glucose, glycated hemoglobin, serum antioxidant level, C peptide, and calculated Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) scores. Participants were randomized to either krill oil or olive oil supplementation for 4 weeks, underwent a 2-week washout period, and then crossed to the other supplementation for 4 weeks. All participants were then offered an additional 17 weeks of krill supplementation. Testing occurred at 3 time points: baseline, after first supplementation, and after second supplementation. Testing also occurred after an optional 17 weeks of krill oil supplementation. Difference scores were calculated for each participant in both sequences (ie, differences in outcome measures in the first and second period of the sequence). The mean and SD of the scores in the 2 sequence groups were used to test for differences between treatment effects at a significance level of p<0.05. Results A total of 47 participants were included in the initial cross-over study. Participants who received krill oil for 4 weeks had an improvement in their endothelial function and a reduction in blood C peptide levels and HOMA scores as compared with the olive oil. A total of 34 participants completed the additional 17-week supplementation period. When compared with their respective baseline measures, these participants had a statistically significant improvement in endothelial function and blood high-density lipoprotein (HDL). Conclusions Krill oil may lead to moderate improvement of cardiovascular risks, specifically endothelial dysfunction and HDL in patients with type 2

  20. 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

  1. The effect of cognitive-behavioral group therapy on depressive symptoms in people with type 2 diabetes: A randomized controlled clinical trial

    PubMed Central

    Sharif, Farkhondeh; Masoudi, Maria; Ghanizadeh, Ahmad; Dabbaghmanesh, Mohammad Hossein; Ghaem, Haleh; Masoumi, Samira

    2014-01-01

    Background: Diabetes mellitus is considered as the most common metabolic disorder. The patients with diabetes are likely to be affected by mental distress, especially depression. Nurses should pay attention to the psychological needs of depressive patients by participating in an application of non-pharmacological treatment such as cognitive-behavioral therapy. This study aimed to assess the effect of cognitive-behavioral group therapy on depression in patients with diabetes. Materials and Methods: This randomized controlled trial was performed in 2010 in the diabetes clinics affiliated to Shiraz University of Medical Sciences, Shiraz, southern Iran. In this study, 60 eligible patients suffering from depression were randomly divided into two groups by convenience sampling method, using random block allocation. The experimental group was randomly subdivided into three groups of 10 each and received eight sessions of cognitive-behavioral group therapy. The level of depression was checked before as well as 2 weeks, 4 weeks, and 2 months after the intervention in both groups. Glycosylated hemoglobin (HbA1c) level was also checked before and 2 months after the intervention. Results: Both groups were demographically homogeneous with no statistically significant difference. The trend in depression scores before as well as 2 weeks, 4 weeks, and 2 months after the intervention was statistically significant in the experimental group (P ≤ 0.001), but not in the control group (P = 0.087). The results showed that HbA1c variation was statistically significant before and after the intervention in both groups (P ≤ 0.001). However, the mean variation of HbA1c was not statistically significant between the groups (P = 0.473). Conclusions: Cognitive-behavioral group therapy was effective in reducing depression in patients with diabetes. Therefore, this method can be recommended for such patients. PMID:25400683

  2. Immune modulation in type 1 diabetes mellitus using DiaPep277: a short review and update of recent clinical trial results.

    PubMed

    Eldor, Roy; Kassem, Sameer; Raz, Itamar

    2009-05-01

    In type 1 diabetes mellitus, autoimmune T-cells mount an attack on insulin producing beta-cells eventually causing hyperglycemia. It is hypothesized, that to prevent and treat this disease, one must interfere with the autoimmune process. To avoid hazardous side effects, this intervention should not cause a global immune suppression but immune modulation. DiaPep277 (peptide 277) is a 24 amino acid peptide derived from positions 437-460 in HSP60. It has recently been shown to have an immune modulatory effect on diabetogenic T cells in animal models of diabetes. It has also been recently implicated as a possible auto-antigen in type 1 diabetes. Promising results in animal models led to phase 1 to 3 human clinical trials in patients with type 1 diabetes, the results of which are the focus of this review. A combined analysis of all the adult phase II studies revealed that DiaPep277 significantly inhibits the decline in stimulated C-peptide secretion (thus preserving endogenous insulin secretion). This effect was more pronounced in patients with a high beta-cell reserve at the start of the treatment. Furthermore, opposite trends in glycemic control of DiaPep277 treated patients where noted as opposed to placebo treated patients. The phase III study has began more than 2 years ago in 40 medical centers worldwide, and thus far recruited over 350 patients around the world. If DiaPep277 will prove to be efficacious, it will cause a paradigm shift in the treatment of type 1 diabetes, from treating the subsequent insulin deficiency to addressing the initial autoimmune process that is at the heart of the disease.

  3. Local adjunct effect of antimicrobial photodynamic therapy for the treatment of chronic periodontitis in type 2 diabetics: split-mouth double-blind randomized controlled clinical trial.

    PubMed

    Castro Dos Santos, Nídia Cristina; Andere, Naira Maria Rebelatto Bechara; Araujo, Cássia Fernandes; de Marco, Andrea Carvalho; Dos Santos, Lúcio Murilo; Jardini, Maria Aparecida Neves; Santamaria, Mauro Pedrine

    2016-11-01

    Diabetes has become a global epidemic. Its complications can have a significant impact on quality of life, longevity, and public health costs. The presence of diabetes might impair the prognosis of periodontal treatments due to its negative influence on wound healing. Antimicrobial photodynamic therapy (aPDT) is a local approach that can promote bacterial decontamination in periodontal pockets. The aim of this study was to investigate the local effect of adjunct aPDT to ultrasonic periodontal debridement (UPD) and compare it to UD only for the treatment of chronic periodontitis in type 2 diabetic patients. Twenty type 2 diabetic patients with moderate to severe generalized chronic periodontitis were selected. Two periodontal pockets with probing depth (PD) and clinical attachment level (CAL) ≥5 mm received UPD only (UPD group) or UPD plus adjunct aPDT (UPD + aPDT group). Periodontal clinical measures were collected and compared at baseline and 30, 90, and 180 days. After 180 days of follow-up, there were statistically significant reductions in PD from 5.75 ± 0.91 to 3.47 ± 0.97 mm in the UPD group and from 6.15 ± 1.27 to 3.71 ± 1.63 mm in the UPD + aPDT group. However, intergroup analysis did not reveal statistically significant differences in any of the evaluated clinical parameters (p > 0.05). The adjunct application of aPDT to UPD did not present additional benefits for the treatment of chronic periodontitis in type 2 diabetic patients. The ClinicalTrials.gov identifier of the present study is NCT02627534.

  4. Is exenatide improving the treatment of type 2 diabetes? Analysis of the individual clinical trials with exenatide.

    PubMed

    Doggrell, Sheila A

    2007-01-01

    The obesity epidemic in the developed and developing world is being followed by an epidemic of type 2 diabetes. In type 2 diabetes, subjects cannot manage glucose properly because they do not produce enough insulin, and the peripheral tissues have become resistant to insulin. Glucagon-like peptide 1 (GLP-1) is an intestinal peptide hormone that is secreted in response to food to regulate the postprandial blood glucose concentration. One of the actions of GLP-1 is to stimulate insulin secretion. In subjects with type 2 diabetes, intravenous or subcutaneous GLP-1 stimulated insulin production and decreased blood glucose levels. However, as GLP-1 is rapidly metabolised, it is not suitable for use in most subjects with type 2 diabetes. Exendin-4 is a 39-amino acid peptide that acts as an agonist at the GLP-1 receptor. After subcutaneous administration, synthetic exendin-4 (exenatide) decreased postprandial concentrations of glucose and insulin, and fasting glucose levels in subjects with type 2 diabetes, and the effects lasted several hours. Subsequently, exenatide was been trialled in subjects taking metformin only, a sulfonylurea only, or metformin and a sulfonylurea, and shown to improve glycemic control with few adverse events, initially over 30 weeks, and then extended to 82 weeks. Exenatide may also be as effective as insulin glargine in subjects with type 2 diabetes not adequately controlled with the oral agents. In conclusion, exenatide represents a new and beneficial addition to the medicines used to treat type 2 diabetes.

  5. Lifestyle Advice Combined with Personalized Estimates of Genetic or Phenotypic Risk of Type 2 Diabetes, and Objectively Measured Physical Activity: A Randomized Controlled Trial

    PubMed Central

    van Sluijs, Esther M. F.; Marteau, Theresa M.; Sutton, Stephen

    2016-01-01

    Background Information about genetic and phenotypic risk of type 2 diabetes is now widely available and is being incorporated into disease prevention programs. Whether such information motivates behavior change or has adverse effects is uncertain. We examined the effect of communicating an estimate of genetic or phenotypic risk of type 2 diabetes in a parallel group, open, randomized controlled trial. Methods and Findings We recruited 569 healthy middle-aged adults from the Fenland Study, an ongoing population-based, observational study in the east of England (Cambridgeshire, UK). We used a computer-generated random list to assign participants in blocks of six to receive either standard lifestyle advice alone (control group, n = 190) or in combination with a genetic (n = 189) or a phenotypic (n = 190) risk estimate for type 2 diabetes (intervention groups). After 8 wk, we measured the primary outcome, objectively measured physical activity (kJ/kg/day), and also measured several secondary outcomes (including self-reported diet, self-reported weight, worry, anxiety, and perceived risk). The study was powered to detect a between-group difference of 4.1 kJ/kg/d at follow-up. 557 (98%) participants completed the trial. There were no significant intervention effects on physical activity (difference in adjusted mean change from baseline: genetic risk group versus control group 0.85 kJ/kg/d (95% CI −2.07 to 3.77, p = 0.57); phenotypic risk group versus control group 1.32 (95% CI −1.61 to 4.25, p = 0.38); and genetic risk group versus phenotypic risk group −0.47 (95% CI −3.40 to 2.46, p = 0.75). No significant differences in self-reported diet, self-reported weight, worry, and anxiety were observed between trial groups. Estimates of perceived risk were significantly more accurate among those who received risk information than among those who did not. Key limitations include the recruitment of a sample that may not be representative of the UK population, use of self

  6. Effects on training and detraining on physical function, control of diabetes and anthropometrics in type 2 diabetes; a randomized controlled trial.

    PubMed

    Park, Sang-Young; Lee, In-Hee

    2015-02-01

    The purpose of this study was to investigate the effect of circuit exercise training and detraining, which is defined by termination of training without additional physical activities, in type 2 diabetic patients. Elderly with type 2 diabetes were divided into a group that exercised for 1 h three times a week for 12 weeks, followed by detraining for 8 weeks, or into a control group. Muscular strength, endurance, flexibility, agility, balance, body mass index (BMI), glycosylated hemoglobin (HbA1c), and blood lipid profile were measured. Of the 98 diabetic participants who joined this study, 37 patients completed the program (exercise group = 24, control group = 13). After training, muscular strength, flexibility, balance, agility, and endurance in the training group were significantly higher than at baseline and compared to the control group. HbA1c levels decreased in the training group. There was no significant improvement in BMI and blood lipid profile in either group. Flexibility and agility in the training group declined significantly after detraining. In spite of this decline, flexibility and agility were significantly higher compared to the baseline and to the control group. In type 2 diabetic patients, circuit training had a beneficial effect on the indices of physical function and glucose metabolism. Training resulted in good improvement; and during detraining, the effect of exercise training was maintained except in some parameters.

  7. Fiber intake and plasminogen activator inhibitor-1 in type 2 diabetes: Look AHEAD (Action for Health in Diabetes) Trial findings at baseline and 1 year

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Plasminogen activator inhibitor 1 (PAI-1) is elevated in obese individuals with type 2 diabetes and may contribute, independently of traditional factors, to increased cardiovascular disease risk. Fiber intake may decrease PAI-1 levels. We examined the associations of fiber intake and its changes wit...

  8. 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…

  9. Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease.

    PubMed

    Green, Jennifer B; Bethel, M Angelyn; Paul, Sanjoy K; Ring, Arne; Kaufman, Keith D; Shapiro, Deborah R; Califf, Robert M; Holman, Rury R

    2013-12-01

    Sitagliptin, an oral dipeptidyl peptidase-4 inhibitor, lowers blood glucose when administered as monotherapy or in combination with other antihyperglycemic agents. TECOS will evaluate the effects of adding sitagliptin to usual diabetes care on cardiovascular outcomes and clinical safety. TECOS is a pragmatic, academically run, multinational, randomized, double-blind, placebo-controlled, event-driven trial recruiting approximately 14,000 patients in 38 countries who have type 2 diabetes (T2DM), are at least 50 years old, have cardiovascular disease, and have an hemoglobin A1c value between 6.5% and 8.0%. Eligible participants will be receiving stable mono- or dual therapy with metformin, sulfonylurea, or pioglitazone, or insulin alone or in combination with metformin. Randomization is 1:1 to double-blind sitagliptin or matching placebo, in addition to existing therapy in a usual care setting. Follow-up occurs at 4-month intervals in year 1 and then twice yearly until 1300 confirmed primary end points have occurred. Glycemic equipoise between randomized groups is a desired aim. The primary composite cardiovascular endpoint is time to the first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina, with cardiovascular events adjudicated by an independent committee blinded to study therapy. TECOS is a pragmatic-design cardiovascular outcome trial assessing the cardiovascular effects of sitagliptin when added to usual T2DM management.

  10. Evaluation of a toolkit to improve cardiovascular disease screening and treatment for people with type 2 diabetes: protocol for a cluster-randomized pragmatic trial

    PubMed Central

    2010-01-01

    Background The gap between the level of care recommended by evidence-based clinical practice guidelines and the actual care delivered to patients in practice has been well established. The Canadian Diabetes Association (CDA) created an implementation strategy to improve the implementation of its 2008 guidelines. This study will evaluate the impact of the strategy to improve cardiovascular disease (CVD) screening, prevention and treatment for people with diabetes. Design A pragmatic cluster-randomized trial will be conducted to evaluate the CDA's CVD Toolkit. All family physicians in Ontario, Canada were randomly allocated to receive the Toolkit, which includes several printed educational materials targeting CVD screening, prevention and treatment, either in spring 2009 (intervention arm) or in spring 2010 (control arm). Randomization occurred at the level of the practice. Forty family physicians from each arm will be recruited to participate, and the medical records for 20 of their diabetic patients at high risk for CVD will be retrospectively reviewed. Outcome measures will be assessed for each patient between July 2009 and March 2010. The primary outcome will be that the patient is receiving a statin. Secondary outcomes will include 1) the receipt of an angiotensin converting enzyme inhibitor or angiotensin receptor blocker, 2) various intermediate measures (A1c, blood pressure, LDL-cholesterol, total-/HDL-cholesterol ratio, body mass index and waist circumference), and 3) clinical inertia (the failure to change therapy in response to an abnormal A1c, blood pressure or cholesterol reading). The analysis will be carried out using multilevel hierarchical logistic regression models to account for the clustered nature of the data. The group assignment will be a physician-level variable. In addition, a process evaluation study with six focus groups of family physicians will assess the acceptability of the CDA's Toolkit and will explore factors contributing to any

  11. Comparison of healing rate in diabetes-related foot ulcers with low frequency ultrasonic debridement versus non-surgical sharps debridement: a randomised trial protocol

    PubMed Central

    2014-01-01

    Background Foot ulceration has been reported as the leading cause of hospital admission and amputation in individuals with diabetes. Diabetes-related foot ulcers require multidisciplinary management and best practice care, including debridement, offloading, dressings, management of infection, modified footwear and management of extrinsic factors. Ulcer debridement is a commonly applied management approach involving removal of non-viable tissue from the ulcer bed. Different methods of debridement have been reported in the literature including autolytic debridement via moist wound healing, mechanical debridement utilising wet to dry dressings, theatre based sharps debridement, biological debridement, non-surgical sharps debridement and newer technology such as low frequency ultrasonic debridement. Methods People with diabetes and a foot ulcer, referred to and treated by the Podiatry Department at Monash Health and who meet the inclusion criteria will be invited to participate in this randomised controlled trial. Participants will be randomly and equally allocated to either the non-surgical sharps debridement (control) or low frequency ultrasonic debridement (intervention) group (n = 322 ulcers/n = 108 participants). Where participants have more than one ulcer, only the participant will be randomised, not the ulcer. An investigator not involved in participant recruitment or assessment will be responsible for preparing the random allocation sequence and envelopes. Each participant will receive weekly treatment for six months including best practice podiatric management. Each ulcer will be measured on a weekly basis by calculating total area in centimetres squared. Measurement will be undertaken by a trained research assistant to ensure outcomes are blinded from the treating podiatrist. Another member of the research team will assess the final primary outcome. Discussion The primary aim of this study is to compare healing rates for diabetes-related foot ulcers

  12. 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

  13. A meta-analysis of trials on aldose reductase inhibitors in diabetic peripheral neuropathy. The Italian Study Group. The St. Vincent Declaration.

    PubMed

    Nicolucci, A; Carinci, F; Cavaliere, D; Scorpiglione, N; Belfiglio, M; Labbrozzi, D; Mari, E; Benedetti, M M; Tognoni, G; Liberati, A

    1996-12-01

    Peripheral neuropathy is one of the most common and disabling long-term sequelae of diabetes mellitus. Aldose reductase inhibitors (ARIs) have been proposed and are increasingly used in many countries for the prevention and treatment of diabetic neuropathy. The aim of this study was to review existing evidence on the effectiveness of ARIs in the treatment of peripheral diabetic neuropathy, with particular reference to the type and clinical relevance of the end point used and to the consistency of results across studies. Thirteen randomized clinical trials (RTCs) comparing ARIs with placebo, published between 1981 and 1993 were included in the meta-analysis. Nerve conduction velocity (NCV) was the only end point reported in all trials. Treatment effect was thus evaluated in terms of NCV mean difference in four different nerves: median motor, median sensory, peroneal motor, and sural sensory. A statistically significant reduction in decline of median motor NCV was present in the treated group as compared to the control group (mean 0.91 ms-1; 95% CI 0.41-1.42 ms-1). For peroneal motor, median sensory, and sural sensory nerves results did not show any clear benefit for patients treated with ARIs. When the analysis was limited to trials with at least 1-year treatment duration, a significant effect was present for peroneal motor NCV (mean 1.24 ms-1; 95% CI 0.32-2.15 ms-1) and a benefit of borderline statistical significance was also present for median motor NCV (mean 0.69 ms-1; 95% CI-0.07-1.45 ms-1). A heterogeneous picture emerged when looking at the results of different studies and serious inconsistencies were also present in the direction of treatment effects among nerves in the same studies. Although the results of 1-year treatment on motor NCV seem encouraging, the uncertainty about the reliability of the end-point employed and the short treatment duration do not allow any clear conclusion about the efficacy of ARIs in the treatment of peripheral diabetic

  14. 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

  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. Analgesic Effect of Topical Sodium Diclofenac before Retinal Photocoagulation for Diabetic Retinopathy: A Randomized Double-masked Placebo-controlled Intraindividual Crossover Clinical Trial

    PubMed Central

    Entezari, Morteza; Shahbazi, Mohammad Mehdi; Semnani, Yosef; Nikkhah, Homayoun; Yaseri, Mehdi

    2017-01-01

    Purpose To evaluate the analgesic effect of topical sodium diclofenac 0.1% before retinal laser photocoagulation for diabetic retinopathy. Methods Diabetic patients who were candidates for peripheral laser photocoagulation were included in a randomized, placebo-controlled, intraindividual, two-period, and crossover clinical trial. At the first session and based on randomization, one eye received topical sodium diclofenac 0.1% and the other eye received an artificial tear drop (as placebo) three times before laser treatment. At the second session, eyes were given the alternate drug. Patients scored their pain using visual analogue scale (max, 10 cm) at both sessions. Patients and the surgeon were blinded to the drops given. Difference of pain level was the main outcome measure. Results A total of 200 eyes of 100 patients were enrolled. Both treatments were matched regarding the applied laser. Pain sensation based on visual analogue scale was 5.6 ± 3.0 in the treated group and 5.5 ± 3.0 in the control group. The calculated treatment effect was 0.15 (95% confidence interval, −0.27 to 0.58; p = 0.486). The estimated period effect was 0.24 (p = 0.530) and the carryover effect was not significant (p = 0.283). Conclusions Pretreatment with topical sodium diclofenac 0.1% does not have any analgesic effect during peripheral retinal laser photocoagulation in diabetic patients. PMID:28367037

  17. Effects of the DASH Diet and Walking on Blood Pressure in Patients With Type 2 Diabetes and Uncontrolled Hypertension: A Randomized Controlled Trial.

    PubMed

    Paula, Tatiana P; Viana, Luciana V; Neto, Alessandra T Z; Leitão, Cristiane B; Gross, Jorge L; Azevedo, Mirela J

    2015-11-01

    Data on the potential beneficial effects of combining diet and exercise on blood pressure (BP) are still scarce. A 4-week randomized controlled clinical trial was undertaken in 40 hypertensive patients with type 2 diabetes with uncontrolled blood pressure (BP) in office and daytime ambulatory BP monitoring (ABPM). Patients were assigned to follow a Dietary Approaches to Stop Hypertension (DASH) diet associated with advice to increase walking using a pedometer (intervention group) or a diet based on the American Diabetes Association recommendations (control group). The lifestyle intervention caused a greater ABPM (mm Hg) reduction in systolic 24-hour, diastolic 24-hour, nighttime systolic, daytime systolic, and daytime diastolic measurements than observed in the control group. In the intervention group there was a decrease in urinary sodium and an increase in urinary potassium, plasma aldosterone, and the number of steps per day (P<.05). The DASH diet and increased walking were associated with clinically significant reductions in ABPM values in hypertensive patients with type 2 diabetes.

  18. 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

  19. Egg ingestion in adults with type 2 diabetes: effects on glycemic control, anthropometry, and diet quality—a randomized, controlled, crossover trial

    PubMed Central

    Njike, Valentine Y; Ayettey, Rockiy G; Rajebi, Hamid; Treu, Judith A; Katz, David L

    2016-01-01

    Background The inclusion of eggs as part of a healthful diet for adults with diabetes is controversial. We examined the effects of including eggs in the diet of adults with type 2 diabetes on cardiometabolic risk factors. Methods Randomized, controlled, single-blind, crossover trial of 34 adults (mean age 64.5 years; 14 postmenopausal women, 20 men) with type 2 diabetes assigned to one of two possible sequence permutations of two different 12-week treatments (two eggs/day inclusion or egg exclusion), with 6-week washout periods. For the egg inclusion phase, participants received advice from a dietitian on how to preserve an isocaloric condition relative to the egg exclusion phase. The primary outcome was glycemic control as measured by glycated hemoglobin. Secondary measures included anthropometry, blood pressure, and diet quality. Results Compared with the exclusion of eggs in the habitual diet, the inclusion of eggs did not measurably affect glycated hemoglobin (0.01±0.5% vs −0.24±0.7%; p=0.115) and systolic blood pressure (−0.8±13.0 vs −3.0±10.0 mm Hg; p=0.438); and significantly reduced body mass index (0.06±0.8 vs −0.4±0.8 kg/m²; p=0.013) and visceral fat rating (0.2±1.1 vs −0.4±1.0; p=0.016). The inclusion of eggs in the habitual diet of diabetics significantly reduced waist circumference (−0.4±1.2 cm; p=0.004) and percent body fat (−0.7±1.8; p=0.033) from baseline. Conclusions Short-term daily inclusion of eggs in the habitual diet of adults with type 2 diabetes does not improve glycemic control but can improve anthropometric measures. Trial registration number NCT02052037; results. PMID:28074139

  20. 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

  1. Supporting insulin initiation in type 2 diabetes in primary care: results of the Stepping Up pragmatic cluster randomised controlled clinical trial.

    PubMed

    Furler, John; O'Neal, David; Speight, Jane; Manski-Nankervis, Jo-Anne; Gorelik, Alexandra; Holmes-Truscott, Elizabeth; Ginnivan, Louise; Young, Doris; Best, James; Patterson, Elizabeth; Liew, Danny; Segal, Leonie; May, Carl; Blackberry, Irene

    2017-03-08

    Objective To compare the effectiveness of a novel model of care ("Stepping Up") with usual primary care in normalising insulin initiation for type 2 diabetes, leading to improved glycated haemoglobin (HbA1c) levels.Design Cluster randomised controlled trial.Setting Primary care practices in Victoria, Australia, with a practice nurse and at least one consenting eligible patient (HbA1c ≥7.5% with maximal oral treatment).Participants 266 patients with type 2 diabetes and 74 practices (mean cluster size 4 (range 1-8) patients), followed up for 12 months.Intervention The Stepping Up model of care intervention involved theory based change in practice systems and reorientation of the roles of health professionals in the primary care diabetes team. The core components were an enhanced role for the practice nurse in leading insulin initiation and mentoring by a registered nurse with diabetes educator credentials.Main outcome measures The primary endpoint was change in HbA1c. Secondary endpoints included the proportion of participants who transitioned to insulin, proportion who achieved target HbA1c, and a change in depressive symptoms (patient health questionnaire, PHQ-9), diabetes specific distress (problem areas in diabetes scale, PAID), and generic health status (assessment of quality of life instrument, AQoL-8D).Results HbA1c improved in both arms, with a clinically significant between arm difference (mean difference -0.6%, 95% confidence interval -0.9% to -0.3%), favouring the intervention. At 12 months, in intervention practices, 105/151 (70%) of participants had started insulin, compared with 25/115 (22%) in control practices (odds ratio 8.3, 95% confidence interval 4.5 to 15.4, P<0.001). Target HbA1c (≤7% (53 mmol/mol)) was achieved by 54 (36%) intervention participants and 22 (19%) control participants (odds ratio 2.2, 1.2 to 4.3, P=0.02). Depressive symptoms did not worsen at 12 months (PHQ-9: -1.1 (3.5) v -0.1 (2.9), P=0.05). A statistically

  2. 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

  3. Glycaemic control with modified intensive insulin injections (MII) using insulin pens and premixed insulin in children with type-1 diabetes: a randomized controlled trial.

    PubMed

    Soliman, Ashraf T; Omar, Magdi; Rizk, Mostafa M; El Awwa, Ahmad; AlGhobashy, Fatma M

    2006-08-01

    The objective of this study was to compare glycemic control and insulin dosage in children with type 1 diabetes treated by a modified intensified insulin therapy MII using insulin pens (and premixed and regular insulin) with those on conventional insulin therapy. This was a longitudinal, randomized controlled trial for 6 months or more. From a cohort of 125 children with previously diagnosed type-1 diabetes (more than a year after diagnosis) two groups were randomly selected Group AI (n=20) and Group B (n=20). Group AI children and 10 children with recently diagnosed type 1 diabetes (Group AII) were allocated to MII using regular insulin and premixed insulin (30/70 and 40/60 and 50/50). Group B patients continued their conventional insulin therapy for the whole period of the trial. The main outcome measures were glycemic control measured by mean blood glucose concentration and percentage of glycated haemoglobin and total daily insulin dose. Mean blood glucose concentrations before the three main meals, and at midnight, (148, 147, 179 and 127 mg/dl, respectively) were lower in children receiving intensified MII compared with those receiving conventional insulin therapy (192, 174, 194 and 179 mg/dl, respectively) (standardized mean difference 34+/-15 mg/dl), equivalent to a difference of 1.9+/-0.8 mmol/l. This improved control during MII was achieved with no change in the average daily insulin dose in group-AI. In group-AII insulin dose decreased significantly during their first 6 moths of treatment (honeymooning). Glycemic control is better during MII using insulin pens and premixed and regular insulin compared with conventional insulin therapy, without any significant change in insulin dose needed to achieve this level of control. The difference in glycemic control between the two methods is significant and could reduce the risk of micro-vascular complications.

  4. Glucose- and glycaemic factor-lowering effects of probiotics on diabetes: a meta-analysis of randomised placebo-controlled trials.

    PubMed

    Sun, Jing; Buys, Nicholas J

    2016-04-14

    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.

  5. Effects of individual micronutrients on blood pressure in patients with type 2 diabetes: a systematic review and meta-analysis of randomized clinical trials.

    PubMed

    de Paula, Tatiana P; Kramer, Caroline K; Viana, Luciana V; Azevedo, Mirela J

    2017-01-13

    To investigate the effects of micronutrients on blood pressure (BP) in patients with type 2 diabetes through a systematic review and meta-analysis, randomized clinical trials (RCTs) of the effects of individual micronutrients on BP in patients with type 2 diabetes were searched in the Medline, Embase, Cochrane, and Clinical Trials.gov databases through April 2016. From the 28,164 studies, 11 RCTs (13 interventions, 723 patients, 54% males) with 3 to 52 weeks of follow-up were classified according to the type of micronutrient intervention: sodium (n = 1), vitamin C (n = 2), vitamin D (n = 7), and magnesium (n = 1). The available data enabled us to perform meta-analyses of vitamins C and D. Vitamin C reduced diastolic BP [WMD -2.88 mmHg (95%CI -5.31, -0.46; P = 0.020)] but not systolic BP [WMD -3.93 mmHg (95%CI -14.78, 6.92; P = 0.478)]. Vitamin D caused a reduction of 4.56 mmHg (WMD; 95%CI -7.65, -1.47; P = 0.004) for systolic BP and 2.44 mm Hg (WMD; 95%CI -3.49, -1.39; P < 0.001) for diastolic BP. In conclusion, vitamin D and possibly vitamin C have beneficial effects on BP in patients with type 2 diabetes. These interventions might represent a novel approach to the treatment of hypertension in these patients.

  6. 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

  7. Sodium glucose co-transport 2 inhibitors in the treatment of type 2 diabetes mellitus: a meta-analysis of randomized double-blind controlled trials

    PubMed Central

    2013-01-01

    Background The discovery of sodium-glucose co-transporter 2 (SGLT2) inhibitors, with a novel mechanism independent of insulin secretion or sensitization, bring about a new therapeutic approach to the management of type 2 diabetes mellitus. The aim of this meta-analysis was to evaluate the safety and efficacy of SGLT2 inhibitors at different doses in randomized double blind clinical trials. Methods This meta-analysis was conducted by including randomized double-blind controlled trials of SGLT2 inhibitors in patients with type 2 diabetes irrespective of their antidiabetic drug exposure history but with an inadequate glycemic control. All the effect sizes were computed using the random effects model. Standardized mean differences (SMDs) and odds ratios (OR) were computed for continuous and dichotomous variables, respectively. Additional analyses like sensitivity analysis, subgroup analysis and meta-regression were also performed. Results The pooled analyses demonstrated a significant reduction in mean changes in Hemoglobin A1c (HbA1c) (SMD = −0.78%, 95% CI, -0.87 to −0.69), fasting plasma glucose (FPG) (SMD = −0.70 mg/dl, 95% CI, -0.79 to −0.61), body weight (overall SMD = −0.59 kg, 95% CI, -0.65 to −0.52) and blood pressure from baseline with SGLT2 inhibitors based therapy. Consistently a significant number of patients treated with SGLT2 inhibitors achieved HbA1c < 7% (OR = 2.09, 95% CI, 1.77 to 2.46). SGLT2 inhibitors based therapy was associated with adverse events like genital and urinary tract infections. Conclusion All studied doses of SGLT2 inhibitors, either as monotherapy or in combination with other antidiabetic agents, consistently improved glycemic control in patients with type 2 diabetes. However, a small percentage of patients suffer from genital and urinary tract infections. PMID:24341330

  8. Screening of gestational diabetes mellitus in early pregnancy by oral glucose tolerance test and glycosylated fibronectin: study protocol for an international, prospective, multicentre cohort trial

    PubMed Central

    Huhn, E A; Fischer, T; Göbl, C S; Todesco Bernasconi, M; Kreft, M; Kunze, M; Schoetzau, A; Dölzlmüller, E; Eppel, W; Husslein, P; Ochsenbein-Koelble, N; Zimmermann, R; Bäz, E; Prömpeler, H; Bruder, E; Hahn, S; Hoesli, I

    2016-01-01

    Introduction As the accurate diagnosis and treatment of gestational diabetes mellitus (GDM) is of increasing importance; new diagnostic approaches for the assessment of GDM in early pregnancy were recently suggested. We evaluate the diagnostic power of an ‘early’ oral glucose tolerance test (OGTT) 75 g and glycosylated fibronectin (glyFn) for GDM screening in a normal cohort. Methods and analysis In a prospective cohort study, 748 singleton pregnancies are recruited in 6 centres in Switzerland, Austria and Germany. Women are screened for pre-existing diabetes mellitus and GDM by an ‘early’ OGTT 75 g and/or the new biomarker, glyFn, at 12–15 weeks of gestation. Different screening strategies are compared to evaluate the impact on detection of GDM by an OGTT 75 g at 24–28 weeks of gestation as recommended by the International Association of Diabetes and Pregnancy Study Groups (IADPSG). A new screening algorithm is created by using multivariable risk estimation based on ‘early’ OGTT 75 g and/or glyFn results, incorporating maternal risk factors. Recruitment began in May 2014. Ethics and dissemination This study received ethical approval from the ethics committees in Basel, Zurich, Vienna, Salzburg and Freiburg. It was registered under http://www.ClinicalTrials.gov (NCT02035059) on 12 January 2014. Data will be presented at international conferences and published in peer-reviewed journals. Trial registration number NCT02035059. PMID:27733413

  9. Effects of individual micronutrients on blood pressure in patients with type 2 diabetes: a systematic review and meta-analysis of randomized clinical trials

    PubMed Central

    de Paula, Tatiana P.; Kramer, Caroline K.; Viana, Luciana V.; Azevedo, Mirela J.

    2017-01-01

    To investigate the effects of micronutrients on blood pressure (BP) in patients with type 2 diabetes through a systematic review and meta-analysis, randomized clinical trials (RCTs) of the effects of individual micronutrients on BP in patients with type 2 diabetes were searched in the Medline, Embase, Cochrane, and Clinical Trials.gov databases through April 2016. From the 28,164 studies, 11 RCTs (13 interventions, 723 patients, 54% males) with 3 to 52 weeks of follow-up were classified according to the type of micronutrient intervention: sodium (n = 1), vitamin C (n = 2), vitamin D (n = 7), and magnesium (n = 1). The available data enabled us to perform meta-analyses of vitamins C and D. Vitamin C reduced diastolic BP [WMD −2.88 mmHg (95%CI −5.31, −0.46; P = 0.020)] but not systolic BP [WMD −3.93 mmHg (95%CI −14.78, 6.92; P = 0.478)]. Vitamin D caused a reduction of 4.56 mmHg (WMD; 95%CI −7.65, −1.47; P = 0.004) for systolic BP and 2.44 mm Hg (WMD; 95%CI −3.49, −1.39; P < 0.001) for diastolic BP. In conclusion, vitamin D and possibly vitamin C have beneficial effects on BP in patients with type 2 diabetes. These interventions might represent a novel approach to the treatment of hypertension in these patients. PMID:28084431

  10. 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

  11. 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

  12. Clinical efficacy and mechanistic evaluation of aflibercept for proliferative diabetic retinopathy (acronym CLARITY): a multicentre phase IIb randomised active-controlled clinical trial

    PubMed Central

    Sivaprasad, Sobha; Prevost, A Toby; Bainbridge, James; Edwards, Rhiannon Tudor; Hopkins, David; Kelly, Joanna; Luthert, Phil; Murphy, Caroline; Ramu, Jayashree; Sarafraz-Shekary, Negin; Vasconcelos, Joana; White-Alao, Beverley; Hykin, Philip

    2015-01-01

    Introduction Proliferative diabetic retinopathy (PDR) is the main cause of severe visual loss in people with diabetes mellitus. The standard treatment for this condition is panretinal photocoagulation (PRP). This laser treatment is inherently destructive, with predictable adverse effects on visual function, and a safer alternative is required. Intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors can induce short-term regression of retinal neovascularisation. The aim of this randomised controlled trial is to determine the efficacy, safety and cost-effectiveness of intravitreal aflibercept, an inhibitor of VEGF-A, VEGF-B and placental growth factor (PLGF), in PDR, and to investigate the impact on local oxygenation. Methods and analysis This is a phase IIb randomised controlled single-masked multicentre clinical trial to determine the impact of repeated intravitreal aflibercept injections in the treatment and prevention of PDR. 220 participants with treatment-naïve or treated but active retinal neovascularisation in at least one eye will be randomly allocated 1:1 to intravitreal aflibercept injections or PRP for a period of 52 weeks. The primary outcome is the change in best-corrected visual acuity in the study eye at 52 weeks. Secondary outcomes include changes from baseline in other visual functions, anatomical changes and cost-effectiveness. Ocular and non-ocular adverse events will also be reported over 52 weeks. Ethics and dissemination The study has been approved by the National Research Ethics Service (NRES) committee with respect to scientific content and compliance with applicable research and human subjects’ regulations. Findings will be reported through scientific publications and research conferences. The results of this study will provide clinical evidence for the feasibility, efficacy safety and cost-effectiveness of intravitreal aflibercept for PDR. Trial registration number ISRCTN 32207582. PMID:26369798

  13. Does metformin improve vascular heath in children with type 1 diabetes? Protocol for a one year, double blind, randomised, placebo controlled trial

    PubMed Central

    2013-01-01

    Background Cardiovascular disease is the leading cause of mortality in Type 1 diabetes (T1D). Vascular dysfunction is an early and critical event in the development of cardiovascular disease. Children with T1D have vascular dysfunction therefore early interventions to improve vascular health are essential to reduce cardiovascular mortality in T1D. Metformin is an insulin sensitising agent which is known to improve vascular health outcomes in type 2 diabetes (T2D) and other individuals with insulin resistance. It has been used safely in children and adolescents with T2D for over 10 years. This study aims to assess the effect of metformin on vascular health in children with T1D. Methods/Design This study is a 12 month, double blind, randomised, placebo controlled trial to determine the effect of metformin on vascular health in children (age 8–18) with T1D. The sample size is 76 with 38 children in the metformin group and 38 children in the placebo group. Vascular health and biochemical markers will be measured at baseline, 3, 6 and 12 months. Vascular function will be measured using flow mediated dilatation and glyceryl trinitrate mediated dilatation of the brachial artery and vascular structure will be measured with carotid and aortic intima media thickness, using standardised protocols. Discussion This study will be the first to investigate the effect of metformin on vascular health in children with T1D. It will provide important information on a potential intervention to improve cardiovascular morbidity and mortality in this population at high risk from cardiovascular disease. Trial registration Australia New Zealand Clinical Trials Registry ACTRN12611000148976 PMID:23865839

  14. 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

  15. Time to onset of neuropathic pain reduction: A retrospective analysis of data from nine controlled trials of pregabalin for painful diabetic peripheral neuropathy and postherpetic neuralgia.

    PubMed

    Sharma, Uma; Griesing, Teresa; Emir, Birol; Young, James P

    2010-01-01

    These retrospective analyses of daily mean pain scores from nine placebo-controlled trials of pregabalin at 150, 300, or 600 mg/day (pregabalin, n = 1205; placebo, n = 772) examined time to significant reduction of pain during the first 2 weeks of treatment of painful diabetic peripheral neuropathy and postherpetic neuralgia. Time to onset of reduction in pain-defined as the first day for which patients treated with pregabalin had significant reductions (P < 0.05) in mean pain score compared with the placebo group for that day and the subsequent day-was calculated for all treatment groups demonstrating statistically significant reduction in pain at trial end point. The time to a 1-point or greater improvement in mean pain score was measured for each patient who was a responder at end point (30% or greater improvement in mean pain score). In seven of the nine trials (representing 11 of 14 pregabalin arms), significant reduction in pain was achieved at end point. The time to onset for reduction in pain was treatment Day 1 or 2 in nine of these successful treatment arms. Individual responder analysis confirmed that responders in the pregabalin groups reported a 1-point or greater pain reduction earlier than responders in placebo groups (P < 0.0001). However, this analysis is not a direct estimate of the likelihood that an individual patient would experience noticeable pain relief by the end of the second day. Overall, for patients who will respond to pregabalin, statistically significant and sustained reduction of pain associated with diabetic peripheral neuropathy and posttherapeutic neuralgia occurs early, usually by the end of 2 days of pregabalin treatment.

  16. 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

  17. 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

  18. 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.

    PubMed

    Schwartz, Ann V; Johnson, Karen C; Kahn, Steven E; Shepherd, John A; Nevitt, Michael C; Peters, Anne L; Walkup, Michael P; Hodges, Amelia; Williams, Carrie C; Bray, George A

    2012-03-01

    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 support and education (DSE) on changes in bone mineral density (BMD) over 12 months. Overweight and obese adults with type 2 diabetes were randomly assigned to ILI or DSE. In a substudy of BMD conducted at 5 of 16 clinical centers, hip, spine, and whole body dual X-ray absorptiometry scans were obtained at baseline and 1-year later on 642 of 739 ILI and 632 of 740 DSE participants. At baseline, mean age was 58.4 years, and average body mass index was 35.2 kg/m(2). Total hip BMD T-score was <-2.5 in 1% and <-1.0 in 8%. At 1 year, weight loss was greater in ILI than DSE (-8.6% versus -0.7%), and glycemic control and fitness were also improved. Bone loss over 1 year was greater in ILI at the total hip (-1.4% versus -0.4%; p < 0.001) and femoral neck (-1.5% versus -0.8%; p = 0.009), but change in BMD for the lumbar spine and whole body did not differ between groups. In ILI, bone loss at the total hip was independently associated with weight loss in men and women and with poorer glycemic control in men, but was not associated with changes in fitness. One year of an intensive lifestyle intervention in adults with type 2 diabetes, resulting in weight loss, was associated with a modest increase in hip bone loss despite improved fitness and glycemic control.

  19. Pistachio Nut Consumption Modifies Systemic Hemodynamics, Increases Heart Rate Variability, and Reduces Ambulatory Blood Pressure in Well‐Controlled Type 2 Diabetes: a Randomized Trial

    PubMed Central

    Sauder, Katherine A.; McCrea, Cindy E.; Ulbrecht, Jan S.; Kris‐Etherton, Penny M.; West, Sheila G.

    2014-01-01

    Background Managing cardiovascular risk factors is important for reducing vascular complications in type 2 diabetes, even in individuals who have achieved glycemic control. Nut consumption is associated with reduced cardiovascular risk; however, there is mixed evidence about the effect of nuts on blood pressure (BP), and limited research on the underlying hemodynamics. This study assessed the effect of pistachio consumption on BP, systemic hemodynamics, and heart rate variability in adults with well‐controlled type 2 diabetes. Methods and Results We enrolled 30 adults (40 to 74 years) with type 2 diabetes in a randomized, crossover, controlled feeding study. After a 2‐week run‐in period, participants consumed a low‐fat control diet (27% fat) containing low‐fat/high‐carbohydrate snacks and a moderate‐fat diet (33% fat) containing pistachios (20% of total energy) for 4 weeks each, separated by a 2‐week washout. Following each diet period, we assessed BP, systemic hemodynamics, and heart rate variability at rest and during acute mental stress, and, in a subset of participants (n=21), 24‐hour ambulatory BP. BP at rest and during stress did not differ between treatments. The pistachio diet significantly reduced total peripheral resistance (−3.7±2.9%, P=0.004), increased cardiac output (3.1±2.3%, P=0.002), and improved some measures of heart rate variability (all P<0.05). Systolic ambulatory BP was significantly reduced by 3.5±2.2 mm Hg (P=0.046) following the pistachio diet, with the greatest reduction observed during sleep (−5.7±2.6 mm Hg, P=0.052). Conclusions A moderate‐fat diet containing pistachios modestly improves some cardiovascular risk factors in adults with well‐controlled type 2 diabetes. Clinical Trial Registration URL: www.clinicaltrials.gov. Unique identifier: NCT00956735. PMID:24980134

  20. 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

  1. 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

  2. The effect of nano-curcumin on HbA1c, fasting blood glucose, and lipid profile in diabetic subjects: a randomized clinical trial

    PubMed Central

    Rahimi, Hamid Reza; Mohammadpour, Amir Hooshang; Dastani, Mostafa; Jaafari, Mahmoud Reza; Abnous, Khalil; Ghayour Mobarhan, Majid; Kazemi Oskuee, Reza

    2016-01-01

    Objective: Diabetes mellitus is defined as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both or insulin resistance. Curcumin inhibits NF-κB signaling pathway. The aim of this study is evaluation of the effect of Nano-curcumin on HbA1C, fast blood glucose and lipid profile in diabetic patients. Materials and Methods: Seventy type-2 diabetic patients (fasting blood glucose (FBG) ≥ 126 mg/dL or 2-hr postprandial blood glucose ≥200 mg/dl) randomly receivedeither Curcumin (as nano-micelle 80 mg/day) or placebo for 3 months in a double blind randomized clinical trial. Fasting blood glucose, HbA1C, and lipids profile were checked before and after the intervention. Data analyses, including parametric and nonparametric tests were done using the SPSS 11.5 software. A p value < 0.05 was regarded as statistically significant. (RCT registration code: IRCT2013081114330N1) Results: Mean age, BMI, FBG, total cholesterol (TC), triglyceride (TG), LDL, HDL, HbA1c , and sex and had no significant difference at the baseline between the groups. In Nano-curcumin group, a significant decrease was found in HbA1C, FBG, TG, and BMI comparing results of each subject before and after the treatment (p<0.05). By comparing pre- and post-treatment values among the groups, HbA1c, eAG, LDL-C, and BMI variables showed significant differences (p<0.05). Conclusion: These findings suggest an HbA1c lowering effect for Nano-curcumin in type-2 diabetes; also, it is partially decrease in serum LDL-C and BMI. PMID:27761427

  3. Effectiveness of a Lifestyle Intervention in Patients with Type 2 Diabetes: The Physical Activity and Nutrition for Diabetes in Alberta (PANDA) Trial

    PubMed Central

    Asaad, Ghada; Soria-Contreras, Diana C.; Bell, Rhonda C.; Chan, Catherine B.

    2016-01-01

    Type 2 diabetes (T2D) patients often find integrating a new dietary pattern into their lifestyle challenging; therefore, the PANDA (Physical Activity and Nutrition for Diabetes in Alberta) menu plan intervention was developed to help people incorporate the Canadian Diabetes Association (CDA) nutrition therapy guidelines into their daily lives. The menu plan focused on recipes and foods that were accessible, available and acceptable to Albertans. The objective was to evaluate the effectiveness of the intervention on blood glucose control and dietary adherence and quality among patients with T2D. Participants with T2D (n = 73) enrolled in a single-arm incorporating interactive education based on a four-week menu plan that incorporated the recommendations of the CDA nutrition therapy guidelines. Post-intervention follow-up was conducted at three and six months. After three months, there were beneficial changes in A1c (−0.7%), body mass index (BMI, −0.6 kg/m2), diastolic blood pressure (−4 mmHg), total cholesterol (−63 mg/dL), HDL- (+28 mg/dL) and LDL-cholesterol (−89 mg/dL), Healthy Eating Index (+2.1 score) and perceived dietary adherence (+8.5 score) (all p < 0.05). The significant improvements in A1c, BMI and lipids were maintained at six months. The PANDA menu plan intervention was effective in improving glycemic control and diet quality. The results suggest that a dietary intervention incorporating interactive education sessions focused on menu planning with familiar, accessible foods may be effective for diabetes management. PMID:27690122

  4. 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

  5. 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

  6. Efficacy of Mobile Apps to Support the Care of Patients With Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    de Araújo, Vânia Eloisa; Godói, Isabella Piassi; de Lemos, Lívia Lovato Pires; Godman, Brian; Bennie, Marion; Diniz, Leonardo Mauricio; Junior, Augusto Afonso Guerra

    2017-01-01

    Background Diabetes Mellitus (DM) is a chronic disease that is considered a global public health problem. Education and self-monitoring by diabetic patients help to optimize and make possible a satisfactory metabolic control enabling improved management and reduced morbidity and mortality. The global growth in the use of mobile phones makes them a powerful platform to help provide tailored health, delivered conveniently to patients through health apps. Objective The aim of our study was to evaluate the efficacy of mobile apps through a systematic review and meta-analysis to assist DM patients in treatment. Methods We conducted searches in the electronic databases MEDLINE (Pubmed), Cochrane Register of Controlled Trials (CENTRAL), and LILACS (Latin American and Caribbean Health Sciences Literature), including manual search in references of publications that included systematic reviews, specialized journals, and gray literature. We considered eligible randomized controlled trials (RCTs) conducted after 2008 with participants of all ages, patients with DM, and users of apps to help manage the disease. The meta-analysis of glycated hemoglobin (HbA1c) was performed in Review Manager software version 5.3. Results The literature search identified 1236 publications. Of these, 13 studies were included that evaluated 1263 patients. In 6 RCTs, there were a statistical significant reduction (P<.05) of HbA1c at the end of studies in the intervention group. The HbA1c data were evaluated by meta-analysis with the following results (mean difference, MD −0.44; CI: −0.59 to −0.29; P<.001; I²=32%).The evaluation favored the treatment in patients who used apps without significant heterogeneity. Conclusions The use of apps by diabetic patients could help improve the control of HbA1c. In addition, the apps seem to strengthen the perception of self-care by contributing better information and health education to patients. Patients also become more self-confident to deal with their

  7. 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

  8. Effectiveness of yoga program in the management of diabetes using community health workers in the urban slums of Bangalore city: A non-randomized controlled trial

    PubMed Central

    Dasappa, Hemavathi; Fathima, Farah Naaz; Prabhakar, Rugmani

    2016-01-01

    Trial Design: Nonrandomized controlled trial. Methods: Nonrandomized controlled trial. This was an interventional study that was conducted in 4 slums of Bengaluru. Of the 256 diabetes participants, only 109 people agreed to participate in the program. Of 109 people, 52 people agreed to participate in the intervention (agreed to learn and practice Yoga) while the remaining 57 people were assigned to nonintervention group. Randomization and blinding could not be done. Objective and Outcome: The study was conducted with objective of assessing the effectiveness of Yoga, Pranayama, and Sudarshan Kriya in the community-based management of diabetes mellitus. The primary outcome variable was Hb1Ac and secondary outcome variables were systolic blood pressure (SBP), diastolic blood pressure (DBP), adherence to medication, and changes in lifestyle. Results: The study was conducted for 40 days. Community health workers made a total of 6 visits during the study. All the 109 participants were available for weekly follow-up. There were no drop outs among the study population. Statistically significant change was seen in the consumption of vegetable (χ2 = 15.326, P < 0.005), fruits (χ2 = 16.207, P < 0.005), salty food (χ2 = 14.823, P < 0.005), bakery food (χ2 = 10.429, P < 0.005) and fried food (χ2 = 15.470, P < 0.005), adherence to metformin (χ2 = 41.780, P < 0.005) and other medication(χ2 = 21.871, P < 0.005) and proportion of patients with DBP under control (χ2 = 9.396, P < 0.005) and proportion of people with glucose random blood sugar under control (χ2 = 29.693, P < 0.005) between the two groups following the intervention. Statistically significant change was also seen in the proportion of people with SBP/DBP ≤140/90 (χ2 = 10.635, P < 0.005) between the two groups. Conclusion: The Yoga program was successful in improving dietary practices and medication adherence and in increasing the proportion of diabetics and hypertensive patients under control. PMID:28217594

  9. Intensive Patient Education Improves Glycaemic Control in Diabetes Compared to Conventional Education: A Randomised Controlled Trial in a Nigerian Tertiary Care Hospital

    PubMed Central

    Essien, Okon; Otu, Akaninyene; Umoh, Victor; Enang, Ofem; Hicks, Joseph Paul; Walley, John

    2017-01-01

    Background Diabetes is now a global epidemic, but most cases are now in low- and middle-income countries. Diabetes self-management education (DSME) is key to enabling patients to manage their chronic condition and can reduce the occurrence of costly and devastating complications. However, there is limited evidence on the effectiveness of different DSME programmes in resource limited settings. Methods We conducted an unblinded, parallel-group, individually-randomised controlled trial at the University of Calabar Teaching Hospital (Nigeria) to evaluate whether an intensive and systematic DSME programme, using structured guidelines, improved glycaemic control compared to the existing ad hoc patient education (clinical practice was unchanged). Eligible patients (≥18 years, HbA1c > 8.5% and physically able to participate) were randomly allocated by permuted block randomisation to participate for six months in either an intensive or conventional education group. The primary outcome was HbA1c (%) at six-months. Results We randomised 59 participants to each group and obtained six-month HbA1c outcomes from 53 and 51 participants in the intensive and conventional education groups, respectively. Intensive group participants had a mean six-month HbA1c (%) of 8.4 (95% CI: 8 to 8.9), while participants in the conventional education group had a mean six-month HbA1c (%) of 10.2 (95% CI: 9.8 to 10.7). The difference was statistically (P < 0.0001) and clinically significant, with intensive group participants having HbA1c outcomes on average -1.8 (95% CI: -2.4 to -1.2) percentage points lower than conventional group participants. Results were robust to adjustment for a range of covariates and multiple imputation of missing outcome data. Conclusions This study demonstrates the effectiveness of a structured, guideline-based DSME intervention in a LMIC setting versus a pragmatic comparator. The intervention is potentially replicable at other levels of the Nigerian healthcare system

  10. 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 age 20–55 years, T2D of at least 6 months duration and body mass index 35–65 kg/m2 for at least 5 years. Randomisation 1:1 to LSG or LRYGB, used random number codes disclosed to the operating surgeon after induction of anaesthesia. A standard medication adjustment schedule will be used during postoperative metabolic assessments. Secondary outcomes include proportions achieving HbA1c<5.7% (39 mmol/mol) or HbA1c<6.5% (48 mmol/mol) without the use of diabetes medication, comparative weight loss, obesity-related comorbidity, operative complications, revision rate, mortality, quality of life, anxiety and depression scores. Exploratory outcomes include changes in satiety, gut hormone and gut microbiota to gain underlying mechanistic insights into T2D remission. Ethics and dissemination Ethics approval was obtained from the New Zealand regional ethics committee (NZ93405) who also provided independent safety monitoring of the trial. Study commenced in September 2011. Recruitment completed in October 2014. Data collection is ongoing. Results will be reported in manuscripts submitted to peer-reviewed journals and in presentations at national and international meetings

  11. 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

  12. 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.…

  13. 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…

  14. 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…

  15. Joint Doctrine for Civil Affairs

    DTIC Science & Technology

    2007-11-02

    Authorities ( MACA ), DODD 5525.5, DOD Cooperation with Civilian Law Enforcement Officials, and JP 3-07.7, Joint Doctrine for Civil Support. II-15 Civil Affairs...Joint Operation Planning and Execution System JP joint publication JTF joint task force LOAC law of armed conflict MACA military assistance to civil

  16. Recent Developments in Student Affairs

    ERIC Educational Resources Information Center

    Holloway, John P.

    1974-01-01

    The rapid development and application to universities and colleges of the constitutional principles of the First Amendment are analyzed with special reference to Healy v. James and its present and possible future ramifications in the area of student affairs including use of university facilities, student conduct, and organizational activities. (JT)

  17. 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,…

  18. 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…

  19. 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…

  20. The Digital Identity of Student Affairs Professionals

    ERIC Educational Resources Information Center

    Ahlquist, Josie

    2016-01-01

    This chapter highlights opportunities in the digital space for student affairs professionals. A blended approach, grounded in the new technology competency recently added in the ACPA and NASPA student affairs professional competencies, is proposed for student affairs professionals' digital identity development. It includes the awareness of one's…

  1. The effect of macrobiotic Ma-Pi 2 diet on systemic inflammation in patients with type 2 diabetes: a post hoc analysis of the MADIAB trial

    PubMed Central

    Soare, Andreea; Del Toro, Rossella; Roncella, Elena; Khazrai, Yeganeh Manon; Angeletti, Silvia; Dugo, Laura; Fallucca, Sara; Fontana, Lucia; Altomare, Maria; Formisano, Valeria; Capata, Francesca; Gesuita, Rosaria; Manfrini, Silvia; Fallucca, Francesco; Pianesi, Mario; Pozzilli, Paolo

    2015-01-01

    Introduction Current guidelines for the management of type 2 diabetes (T2D) emphasize diet as essential therapy. However, the effect of diet on systemic inflammation remains unclear. We investigated the effects of consuming a macrobiotic Ma-Pi 2 diet versus a standard recommended diet (control diet) on markers of inflammation in patients with T2D. Methods This was a post hoc analysis of the MADIAB trial, a 21-day randomized controlled trial conducted in 51 patients (25 males and 26 females) with T2D. Patients were randomized 1:1 to the Ma-Pi 2 macrobiotic diet or a control diet based on dietary guidelines for T2D. Biological antioxidant potential of plasma and circulating levels of high-sensitivity C reactive protein, interleukin-6, tumor necrosis factor-α, and insulin-like growth factor-1 were assessed. Results After 21 days on the Ma-Pi 2 or control diet, markers of inflammation were reduced in both groups. The antioxidant potential of plasma improved significantly in the Ma-Pi group. A significant reduction in insulin growth factor-1 was observed in the Ma-Pi group versus control group (p<0.001). Conclusions Findings of this post hoc analysis demonstrated that the Ma-Pi 2 diet is a safe dietary strategy to reduce levels of the markers of insulin resistance and inflammation, compared with baseline values, in the short term. Furthermore, the Ma-Pi 2 diet was superior to the control diet in reducing insulin growth factor-1 and may be beneficial for patients with T2D. Trial registration number Current Controlled Trials ISRCTN10467793. PMID:25852946

  2. Microvascular Outcomes after Metabolic Surgery (MOMS) in patients with type 2 diabetes mellitus and class I obesity: rationale and design for a randomised controlled trial

    PubMed Central

    Cohen, Ricardo Vitor; Pereira, Tiago Veiga; Aboud, Cristina Mamédio; Caravatto, Pedro Paulo de Paris; Petry, Tarissa Beatrice Zanata; Correa, José Luis Lopes; Schiavon, Carlos Aurélio; Correa, Mariangela; Pompílio, Carlos Eduardo; Pechy, Fernando Nogueira Quirino; le Roux, Carel

    2017-01-01

    Introduction There are several randomised controlled trials (RCTs) that have already shown that metabolic/bariatric surgery achieves short-term and long-term glycaemic control while there are no level 1A of evidence data regarding the effects of surgery on the microvascular complications of type 2 diabetes mellitus (T2DM). Purpose The aim of this trial is to investigate the long-term efficacy and safety of the Roux-en-Y gastric bypass (RYGB) plus the best medical treatment (BMT) versus the BMT alone to improve microvascular outcomes in patients with T2DM with a body mass index (BMI) of 30–34.9 kg/m2. Methods and analysis This study design includes a unicentric randomised unblinded controlled trial. 100 patients (BMI from 30 to 34.9 kg/m2) will be randomly allocated to receive either RYGB plus BMT or BMT alone. The primary outcome is the change in the urine albumin-to-creatinine ratio (uACR) captured as the proportion of patients who achieved nephropathy remission (uACR<30 mg/g of albumin/mg of creatinine) in an isolated urine sample over 12, 24 and 60 months. Ethics and dissemination The study was approved by the local Institutional Review Board. This study represents the first RCT comparing RYGB plus BMT versus BMT alone for patients with T2DM with a BMI below 35 kg/m2. Trial registration number NCT01821508; Pre-results. PMID:28077412

  3. Effects of thai foot massage on balance performance in diabetic patients with peripheral neuropathy: a randomized parallel-controlled trial.

    PubMed

    Chatchawan, Uraiwan; Eungpinichpong, Wichai; Plandee, Piyawan; Yamauchi, Junichiro

    2015-04-20

    BACKGROUND Peripheral neuropathy is the most common complications of diabetic patients and leads to loss of plantar cutaneous sensation, movement perception, and body balance. Thai foot massage is an alternative therapy to improve balance. Therefore, the purpose of this study was to investigate the effects of Thai foot massage on balance performance in diabetic patients with peripheral neuropathy. MATERIAL AND METHODS Sixty patients with type-2 diabetes were recruited and randomly assigned into either the Thai foot massage or control groups. The Thai foot massage group received a modified Thai traditional foot massage for 30 min, 3 days per week for 2 weeks. We measured timed up and go (TUG), one leg stance: OLS), the range of motion (ROM) of the foot, and foot sensation (SWMT) before treatment, after the first single session, and after the 2-week treatment. RESULTS After the single treatment session, only the Thai foot massage group showed a significant improvement in TUG. After the 2-week treatment, both Thai foot massage and control groups showed a significant improvement of TUG and OLS (P<0.05); however, when comparing between 2 groups, the Thai foot massage group showed better improvement in TUG than the control group (p<0.05). The Thai foot massage group also showed significant improvements in ROM and SWMT after the 2-week treatment. CONCLUSIONS The results of this study suggest that Thai foot massage is a viable alternative treatment for balance performance, ROM of the foot, and the foot sensation in diabetic patients with peripheral neuropathy.

  4. Association of Type 2 diabetes susceptibility loci with one- year weight loss in the Look AHEAD Clinical Trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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 circumferenc...

  5. A Randomized Controlled Trial of Acceptance and Commitment Therapy for Type 2 Diabetes Management: The Moderating Role of Coping Styles

    PubMed Central

    Shayeghian, Zeinab; Hassanabadi, Hamidreza; Aguilar-Vafaie, Maria E.; Amiri, Parisa; Besharat, Mohammad Ali

    2016-01-01

    Background and Aim Evidence of the efficacy of existing psychological interventions for self-management in diabetes is limited. The current study aimed at assessing the effects of group-based ACT on self-management of patients with T2DM, considering the moderating role of coping styles. Methods One hundred and six patients with type 2 diabetes were randomly assigned either to the education alone (n = 53) or to a combination of education and group-based acceptance and commitment therapy (n = 53) over a period of 10 sessions. In each group, 50 participants completed a 3 month follow-up assessment. Results After 3 months, compared to patients who received education alone, those in the group-based acceptance and commitment therapy condition were more likely to use effective coping strategies, reported better diabetes self-care, and optimum glycated hemoglobin (HbA1C) levels in the target range. Conclusions Consideration of the role of coping style for a more accurate evaluation of the effects of acceptance and commitment therapy may be a useful addition to services provided for patients with type 2 diabetes. PMID:27907074

  6. The look AHEAD trial: bone loss at four-year follow-up in type 2 diabetes

    Technology Transfer Automated Retrieval System (TEKTRAN)

    OBJECTIVE: To determine whether an intensive lifestyle intervention (ILI) designed to sustain weight loss and improve physical fitness in overweight or obese persons with type 2 diabetes was associated with bone loss after 4 years of follow-up. RESEARCH DESIGN AND METHODS: This randomized controlled...

  7. A Randomized Trial about Glycemic Index and Glycemic Load Improves Outcomes among Adults with Type 2 Diabetes

    ERIC Educational Resources Information Center

    Miller, Carla K.; Gutschall, Melissa

    2009-01-01

    Glycemic index (GI) represents the postprandial glucose response of carbohydrate foods, and glycemic load (GL) represents the quantity and quality of carbohydrate consumed. A diet lower in GI and GL may improve diabetes management. A 9-week intervention regarding GI and GL was evaluated among adults in the age range of 40-70 years who had had type…

  8. Improving Diabetes Care and Health Measures among Hispanics Using Community Health Workers: Results from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Babamoto, Kenneth S.; Sey, Kwa A.; Camilleri, Angela J.; Karlan, Vicki J.; Catalasan, Joana; Morisky, Donald E.

    2009-01-01

    The increasing prevalence of diabetes and obesity, growing health disparities, and shortage of bilingual and culturally trained health care professionals underscore the role of trained community health workers (CHWs) to provide economically sustainable and culturally relevant services. This prospective randomized design evaluated the relative…

  9. The Effects of a Computer-Tailored Message on Secondary Prevention in Type 2 Diabetes: A Randomized Trial

    PubMed Central

    Adams, Sandra Y.; Crawford, Albert G.; Rimal, Rajiv N.; Lee, Joyce S.; Janneck, Laura M.

    2009-01-01

    Abstract The purpose of this study was to test the effect of computer-generated, tailored feedback on the quality of chronic disease management for type 2 diabetes when provided to a patient prior to a scheduled physician visit. A stand-alone computer application was developed to provide tailored feedback aimed at empowering patients to engage more actively in their diabetes management. Adults with type 2 diabetes (n = 203) were randomly assigned to groups receiving either efficacy (positive) messages (n = 68), risk (negative) messages (n = 67), or to a delayed treatment control group (n = 68). The intervention was delivered prior to a patient's visit with his or her physician so that patients would have the opportunity to discuss the messages at the clinical appointment. Although there were no significant differences in the percentage of participants who received intensified care or routine tests between the control and intervention groups, we learned that more directive messaging may be needed to help patients effectively manage their diabetes. Patients may benefit from directive feedback, providing them with specific questions to ask their physician that can lead to improved care, rather than receiving general and educational informational messages. (Population Health Management 2009;12:197–204) PMID:19663622

  10. Natural antioxidants in the treatment and prevention of diabetic nephropathy; a potential approach that warrants clinical trials.

    PubMed

    Al-Waili, Noori; Al-Waili, Hamza; Al-Waili, Thia; Salom, Khelod

    2017-05-01

    Diabetic nephropathy is the major cause of end-stage renal disease and effective and new therapeutic approaches are needed in diabetic nephropathy and chronic kidney diseases. Oxidative stress and inflammatory process are important factors contributing to kidney damage by increasing production of oxidants. KEAP1/Nrf2/ARE pathway regulates the transcription of many antioxidant genes and modulation of the pathway up regulates antioxidants. NFB controls the expression of genes involved in the inflammatory response. Natural substances have antioxidant and anti-inflammatory activities and have an impact on NFB and KEAP1/Nrf2/ARE pathways. The preclinical studies explored the effectiveness of whole herbs, plants or seeds and their active ingredients in established diabetic nephropathy. They ameliorate oxidative stress induced kidney damage, enhance antioxidant system, and decrease inflammatory process and fibrosis; most likely by activating KEAP1/Nrf2/ARE pathway and by deactivating NFB pathway. Whole natural products contain balanced antioxidants that might work synergistically to induce beneficial therapeutic outcome. In this context, more clinical studies involving whole plants or herbal products or mixtures of different herbs and plants and their active ingredients might change our strategies for the management of diabetic nephropathy. The natural products might be useful as preventive interventions and studies are required in this field.

  11. Evaluation of a Behavioral Mobile Phone App Intervention for the Self-Management of Type 2 Diabetes: Randomized Controlled Trial Protocol

    PubMed Central

    Lewis, Gary; Yu, Catherine; Rotondi, Michael; Seto, Emily; Cafazzo, Joseph A

    2016-01-01

    Background Patients with type 2 diabetes mellitus (T2DM) struggle with the management of their condition due to difficulty relating lifestyle behaviors with glycemic control. While self-monitoring of blood glucose (SMBG) has proven to be effective for those treated with insulin, it has been shown to be less beneficial for those only treated with oral medications or lifestyle modification. We hypothesized that the effective self-management of non-insulin treated T2DM requires a behavioral intervention that empowers patients with the ability to self-monitor, understand the impact of lifestyle behaviors on glycemic control, and adjust their self-care based on contextualized SMBG data. Objective The primary objective of this randomized controlled trial (RCT) is to determine the impact of bant2, an evidence-based, patient-centered, behavioral mobile app intervention, on the self-management of T2DM. Our second postulation is that automated feedback delivered through the mobile app will be as effective, less resource intensive, and more scalable than interventions involving additional health care provider feedback. Methods This study is a 12-month, prospective, multicenter RCT in which 150 participants will be randomly assigned to one of two groups: the control group will receive current standard of care, and the intervention group will receive the mobile phone app system in addition to standard of care. The primary outcome measure is change in glycated hemoglobin A1c from baseline to 12 months. Results The first patient was enrolled on July 28, 2015, and we anticipate completing this study by September, 2018. Conclusions This RCT is one of the first to evaluate an evidence-based mobile app that focuses on facilitating lifestyle behavior change driven by contextualized and structured SMBG. The results of this trial will provide insights regarding the usage of mobile tools and consumer-grade devices for diabetes self-care, the economic model of using incentives to motivate

  12. A randomized controlled trial of the effects of nurse case manager and community health worker team interventions in urban African-Americans with type 2 diabetes.

    PubMed

    Gary, Tiffany L; Batts-Turner, Marian; Bone, Lee R; Yeh, Hsin-Chieh; Wang, Nae-Yuh; Hill-Briggs, Felicia; Levine, David M; Powe, Neil R; Hill, Martha N; Saudek, Christopher; McGuire, Maura; Brancati, Frederick L

    2004-02-01

    The objective of the study was to determine the effectiveness and cost-effectiveness of primary care and community-oriented interventions in managing HbA1c, blood pressure, and lipids, and reducing hospitalizations and emergency room visits over 2 years. We describe an ongoing, randomized controlled trial of 542 urban African-Americans with type 2 diabetes ages 25 years and older who are members of a university-affiliated managed-care organization in Baltimore, MD. The participants are 74% female, have a mean age of 58 years, and 35% have yearly incomes greater than 7500 US dollars. Participants were randomized to one of two intervention groups for a period of 2 years: (1) usual medical care plus minimal telephone intervention implemented by a trained lay health educator (control group) or (2) usual medical care plus intensive intervention implemented by a nurse case manager (NCM)/community health worker (CHW) team. The intensive NCM/CHW team executes individual plans of care using evidence-based algorithms that focus on traditional diabetes self-management, screening and management of diabetes-related complications, and social issues surrounding diabetes care. Face-to-face NCM visits are conducted in the clinic once per year and CHW visits are conducted in the participant's home one to three times per year, both with additional follow-up contacts as needed. Written and verbal feedback (when necessary) is provided to the participant's primary care physician. All participants are expected to attend a 24-month follow-up visit where data are collected by interviewers blinded to intervention assignment. As of May 1, 2003, recruitment is complete, interventions are being fully implemented, and 24-month follow-up visits are beginning. Baseline sociodemographic characteristics, health-care utilization, health behaviors, and clinical characteristics of the study population are reported. This study is designed to test the hypothesis that a primary-care-based NCM plus CHW

  13. Resistant dextrin, as a prebiotic, improves insulin resistance and inflammation in women with type 2 diabetes: a randomised controlled clinical trial.

    PubMed

    Aliasgharzadeh, Akbar; Dehghan, Parvin; Gargari, Bahram Pourghassem; Asghari-Jafarabadi, Mohammad

    2015-01-28

    Improvement of insulin resistance and inflammation is a basic strategy in the management of type 2 diabetes. There is limited evidence that prebiotics improve insulin resistance and inflammation. However, the ameliorating effect of resistant dextrin, as a prebiotic, on insulin resistance and inflammation in patients with type 2 diabetes has not been investigated so far. Therefore, the present study aimed to examine the effects of resistant dextrin on insulin resistance and inflammation in type 2 diabetic patients. In a randomised controlled clinical trial, fifty-five women with type 2 diabetes were assigned to two groups: the intervention group (n 30) and the control group (n 25). The intervention group received a daily supplement of 10 g resistant dextrin and the control group received a similar amount of maltodextrin as placebo for 8 weeks. Fasting plasma glucose (FPG), HbA1c, insulin, high-sensitivity C-reactive protein (hs-CRP), IL-6, TNF-α, malondialdehyde (MDA) and serum endotoxin concentrations were measured before and after the intervention. Data were analysed using SPSS (version 13). Paired and unpaired t tests and ANCOVA were used to compare quantitative variables after the intervention. Patients supplemented with resistant dextrin exhibited a significant decrease in fasting insulin (20.1 pmol/l, 22.8%), homeostasis model assessment of insulin resistance (1.3, 24.9%), quantitative insulin sensitivity check index (0.2, 7.2%), IL-6 (1.4 pg/ml, 28.4 %), TNF-α (5.4 pg/ml, 18.8 %), MDA (1.2 nmol/ml, 25.6 %) and endotoxin (6.2 endotoxin units/ml, 17.8%) concentrations than those supplemented with maltodextrin (P< 0.05). Decreases in FPG (0.05 mmol/l, 0.6%), HbA1c (0.5%, 9.6%) and hs-CRP (2.7 ng/ml, 35.1%) concentrations in the resistant dextrin group were not significant when compared with the maltodextrin group. In conclusion, resistant dextrin supplementation can modulate inflammation and improve insulin resistance in women with type 2 diabetes.

  14. Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial

    PubMed Central

    Wayne, Noah; Perez, Daniel F; Kaplan, David M

    2015-01-01

    Background Adoptions of health behaviors are crucial for maintaining good health after type 2 diabetes mellitus (T2DM) diagnoses. However, adherence to glucoregulating behaviors like regular exercise and balanced diet can be challenging, especially for people living in lower-socioeconomic status (SES) communities. Providing cost-effective interventions that improve self-management is important for improving quality of life and the sustainability of health care systems. Objective To evaluate a health coach intervention with and without the use of mobile phones to support health behavior change in patients with type 2 diabetes. Methods In this noninferiority, pragmatic randomized controlled trial (RCT), patients from two primary care health centers in Toronto, Canada, with type 2 diabetes and a glycated hemoglobin/hemoglobin A1c (HbA1c) level of ≥7.3% (56.3 mmol/mol) were randomized to receive 6 months of health coaching with or without mobile phone monitoring support. We hypothesized that both approaches would result in significant HbA1c reductions, although health coaching with mobile phone monitoring would result in significantly larger effects. Participants were evaluated at baseline, 3 months, and 6 months. The primary outcome was the change in HbA1c from baseline to 6 months (difference between and within groups). Other outcomes included weight, waist circumference, body mass index (BMI), satisfaction with life, depression and anxiety (Hospital Anxiety and Depression Scale [HADS]), positive and negative affect (Positive and Negative Affect Schedule [PANAS]), and quality of life (Short Form Health Survey-12 [SF-12]). Results A total of 138 patients were randomized and 7 were excluded for a substudy; of the remaining 131, 67 were allocated to the intervention group and 64 to the control group. Primary outcome data were available for 97 participants (74.0%). While both groups reduced their HbA1c levels, there were no significant between-group differences in

  15. 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…

  16. LEADER 2: baseline calcitonin in 9340 people with type 2 diabetes enrolled in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial: preliminary observations

    PubMed Central

    Daniels, G H; Hegedüs, L; Marso, S P; Nauck, M A; Zinman, B; Bergenstal, R M; Mann, J F E; Derving Karsbøl, J; Moses, A C; Buse, J B; Tuttle, R M

    2015-01-01

    Aims To report preliminary data on baseline serum calcitonin concentrations and associated clinical characteristics in a global population with type 2 diabetes before liraglutide or placebo randomization. Methods The ongoing LEADER trial has enrolled 9340 people with type 2 diabetes and at high risk of cardiovascular disease at 410 centres worldwide. People with baseline serum calcitonin ≤50 ng/l were randomized to liraglutide once daily or placebo and will be followed for up to 5 years. Serum calcitonin was measured at baseline and will be measured annually thereafter. An independent committee of thyroid experts will oversee calcitonin monitoring throughout the trial and will review all calcitonin concentrations ≥20 ng/l. Results The mean age of participants was 64.3 ± 7.2 years, 64.3% were men, and mean the body mass index was 32.5 ± 6.3 kg/m2. The median (interquartile range) baseline serum calcitonin values were 3.9 (1.0 to >7.6) ng/l in men and 1.0 (1.0 to >1) ng/l in women. Serum calcitonin was >10 ng/l in 14.6% of men and in 0.96% of women. In sex-specific multivariable linear analysis of covariance models, a reduced glomerular filtration rate (GFR) was associated with higher serum calcitonin concentrations that were statistically significant. A 20 ml/min/1.73 m2 decrease in estimated GFR (eGFR) was associated with a 14% increase in serum calcitonin in women and an 11% increase in men. Conclusions In the LEADER population, the prevalence of elevated serum calcitonin concentrations at baseline was high, and there was an inverse association between eGFR and serum calcitonin concentrations. PMID:25656058

  17. Intensification of insulin therapy with basal-bolus or premixed insulin regimens in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.

    PubMed

    Giugliano, Dario; Chiodini, Paolo; Maiorino, Maria Ida; Bellastella, Giuseppe; Esposito, Katherine

    2016-03-01

    The purpose of this study was to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing the effect of intensified insulin regimens (basal-bolus versus premixed) on glycemic control in patients with type 2 diabetes. We conducted an electronic search until March 2015 on many electronic databases including online registries of ongoing trials. All RCTs comparing basal-bolus with premixed insulin regimens, with a duration of >12 weeks and with >30 patients per arm, were included. Investigators extracted data on study characteristics, outcome measures, and methodological quality. We found thirteen RCTs lasting 16-60 weeks and involving 5255 patients assessed for the primary endpoint (reduction of HbA1c from baseline). Meta-analysis of change in HbA1c level between basal-bolus and premixed insulin regimens resulted in a small and non-significant difference of 0.09% (95% CI -0.03 to 0.21), with substantial heterogeneity between studies (I(2) = 74.4%). There was no statistically significant difference in the event rate for overall hypoglycemia (0.16 episode/patient/year, 95%CI -2.07 to 2.3), weight change (-0.21 kg, -0.164 to 0.185), and daily insulin dose (-0.54 U/day, -2.7 to 1.6). The likelihood for reaching the HbA1c <7% was 8% higher (3-13%, I(2) = 68.8%) with the basal-bolus as compared with the premixed regimen. There is no clinically relevant difference in the efficacy of basal-bolus versus premixed insulin regimens for HbA1c decrease in type 2 diabetic patients. These findings may be helpful to adapt treatment to individual patient needs.

  18. Liuwei Dihuang Pills Enhance the Effect of Western Medicine in Treating Diabetic Nephropathy: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Lin, Lan; Wang, Qiuhong; Yi, Yongxin; Wang, Shihan; Qiu, Zonglin

    2016-01-01

    Objectives. To assess the effectiveness and adverse effects of adding Liuwei Dihuang Pills (LDP) to Western medicine for treating diabetic nephropathy. Methods. Studies were retrieved from seven electronic databases, including PubMed, Embase, The Cochrane Library, CBM, CNKI, Chinese Scientific Journal Database (VIP), and Wanfang Data until November 2015. Study selection, data extraction, quality assessment, and data analyses were conducted according to Cochrane standards. Meta-analysis was performed on the overall therapeutic efficacy of hyperglycemia and renal functions, and the study also analyzed adverse events. Results. A total of 1,275 patients from 18 studies were included. The methodological quality of these included trials was generally low. We found that adding LDP can lower patients' FBG (MD: −0.36 [−0.46, −0.25], P < 0.00001), PBG (MD: −1.10 [−1.35, −0.85], P < 0.00001), and HbA1c (MD: −0.14 [−0.49, 0.21], P = 0.43). There were also improvements in lowering patients' BUN (MD: −0.67 [−0.89, −0.45], P < 0.00001), SCr (MD: −0.96 [−1.53, −0.39], P < 0.00001), 24 h UTP (SMD: −1.26 [−2.38, −0.15], P < 0.00001), UAER (MD: −26.18 [−27.51, −24.85], P < 0.00001), and UmAlb (SMD: −1.72 [−2.67, −0.77], P < 0.00001). Conclusion. There is encouraging evidence that adding LDP to Western medicine might improve treatment outcomes of diabetic nephropathy, including hyperglycemia and renal functions. However, the evidence remains weak. More rigorous high-quality trials are warranted to substantiate or refute the results. PMID:26997962

  19. Effect of preoperative topical diclofenac on intraocular interleukin-12 concentration and macular edema after cataract surgery in patients with diabetic retinopathy: a randomized controlled trial

    PubMed Central

    Medić, Aleksej; Jukić, Tomislav; Matas, Anita; Vukojević, Katarina; Sapunar, Ada; Znaor, Ljubo

    2017-01-01

    Aim To determine if preoperative treatment with a topical non-steroidal anti-inflammatory drug (NSAID) lowers the concentration of intraocular interleukin (IL)-12 and the incidence of postoperative macular edema in patients with non-proliferative diabetic retinopathy undergoing cataract surgery. Methods A total of 55 patients were randomized to diclofenac (n = 27) or placebo (n = 28). Patients receiving diclofenac started preoperative treatment with 0.1% topical diclofenac four times a day 7 days before cataract surgery and the therapy was discontinued 30 days after surgery. Patients in the control group were administered placebo 7 days preoperatively and a standard postoperative therapy with 0.1% topical dexamethasone four times a day for 30 days after surgery. All patients received postoperative antibiotic prophylaxis with tobramycin eye drops four times daily for 30 days. Seven days before the cataract surgery, on the day of surgery, and 1, 7, 30, and 90 days after surgery, central foveal thickness (CFT) was measured with optical coherence tomography (OCT) and the aqueous humor was sampled at the beginning of cataract surgery for the analysis of IL-12 concentration. Due to loss to follow-up and insufficient aqueous humor samples, the data of 3 patients treated with diclofenac and 8 patients receiving placebo were not analyzed. Results The aqueous humor IL-12 concentration was significantly lower in the diclofenac group than in the placebo group (t=−2.85, P = 0.007). The diclofenac group had a significantly smaller increase in CFT after phacoemulsification (F = 13.57, p<0.001). Conclusion Patients preoperatively treated with diclofenac had significantly lower intraocular levels of IL-12 and a lower increase in CFT, which indicates that a combination of preoperative and postoperative treatment with a topical NSAID may lower the incidence of postoperative macular edema in patients with diabetic retinopathy. ClinicalTrials.gov trial registration

  20. Effects of Insulin Detemir and NPH Insulin on Body Weight and Appetite-Regulating Brain Regions in Human Type 1 Diabetes: A Randomized Controlled Trial

    PubMed Central

    van Golen, Larissa W.; Veltman, Dick J.; IJzerman, Richard G.; Deijen, Jan Berend; Heijboer, Annemieke C.; Barkhof, Frederik; Drent, Madeleine L.; Diamant, Michaela

    2014-01-01

    Studies in rodents have demonstrated that insulin in the central nervous system induces satiety. In humans, these effects are less well established. Insulin detemir is a basal insulin analog that causes less weight gain than other basal insulin formulations, including the current standard intermediate-long acting Neutral Protamine Hagedorn (NPH) insulin. Due to its structural modifications, which render the molecule more lipophilic, it was proposed that insulin detemir enters the brain more readily than other insulins. The aim of this study was to investigate whether insulin detemir treatment differentially modifies brain activation in response to food stimuli as compared to NPH insulin. In addition, cerebral spinal fluid (CSF) insulin levels were measured after both treatments. Brain responses to viewing food and non-food pictures were measured using functional Magnetic Resonance Imaging in 32 type 1 diabetic patients, after each of two 12-week treatment periods with insulin detemir and NPH insulin, respectively, both combined with prandial insulin aspart. CSF insulin levels were determined in a subgroup. Insulin detemir decreased body weight by 0.8 kg and NPH insulin increased weight by 0.5 kg (p = 0.02 for difference), while both treatments resulted in similar glycemic control. After treatment with insulin detemir, as compared to NPH insulin, brain activation was significantly lower in bilateral insula in response to visual food stimuli, compared to NPH (p = 0.02 for right and p = 0.05 for left insula). Also, CSF insulin levels were higher compared to those with NPH insulin treatment (p = 0.003). Our findings support the hypothesis that in type 1 diabetic patients, the weight sparing effect of insulin detemir may be mediated by its enhanced action on the central nervous system, resulting in blunted activation in bilateral insula, an appetite-regulating brain region, in response to food stimuli. Trial Registration ClinicalTrials.gov NCT00626080

  1. Prevention of diabetes and cardiovascular disease in patients with impaired glucose tolerance: rationale and design of the Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) Trial.

    PubMed

    Califf, Robert M; Boolell, Mitradev; Haffner, Steven M; Bethel, M Angelyn; McMurray, John; Duggal, Anil; Holman, Rury R

    2008-10-01

    Patients with impaired glucose tolerance (IGT) have increased risk for developing type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). Lifestyle modification and medication can prevent or delay progression to diabetes (PD), but whether such interventions also reduce the risk of CVD has not been rigorously tested. The Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial is a multinational, randomized, double-blind, 2 x 2 factorial trial in subjects with IGT (on a screening oral glucose tolerance test [OGTT]) aged > or = 50 years with known CVD or aged > or = 55 years with > or = 1 CVD risk factor. Enrollment began in January 2002 and was completed January 2004, with 9,518 patients randomized to receive 1 of 4 possible treatment combinations as follows: nateglinide with valsartan, nateglinide with valsartan-placebo, nateglinide-placebo with valsartan, or nateglinide-placebo with valsartan-placebo. All subjects are participating in a clinic-based and telephone-based lifestyle intervention aimed at reducing weight and dietary fat and increasing physical activity. The 3 coprimary end points are new onset of T2DM, a "core" composite of major cardiovascular events (death, myocardial infarction, stroke, or hospitalization for heart failure), and an "extended" composite including the components of the core composite plus coronary revascularization and hospitalization for unstable angina. The study was designed to evaluate whether reducing postprandial hyperglycemia, blockade of the renin-angiotensin-aldosterone system, or both interventions reduce the risk of T2DM or cardiovascular events in patients with IGT.

  2. The Effect of Green Tea versus Sour Tea on Insulin Resistance, Lipids Profiles and Oxidative Stress in Patients with Type 2 Diabetes Mellitus: A Randomized Clinical Trial

    PubMed Central

    Mozaffari-Khosravi, Hassan; Ahadi, Zeinab; Fallah Tafti, Marziyeh

    2014-01-01

    Background: By decreasing oxidative stress and whereby decreasing insulin resistance, it may be possible to decrease complications of Diabetes Mellitus (DM). Green tea and sour tea contain phytochemicals which have anti-oxidative function. The aim of this study is to compare the effect of sour and green tea consumption on insulin resistance and oxidative stress in DM. Methods: This study is a randomized clinical trial in which 100 type 2 diabetes patients were randomly assigned into sour tea group (ST) and green tea group (GT). The patients were instructed to drink 150ml sour tea and green tea infusion, respectively, three times a day for 4 weeks. Fasting blood sugar (FBS), fructosamine, lipid profiles, fasting blood insulin (FBI), homeostasis model assessment of insulin resistance (HOMA-IR); beta cell function (b%), insulin sensitivity (S%) and malondialdehyde (MDA) were monitored. Results: HDL-c significantly increased in both groups. The median of FBI in GT showed significant decrease (8.5 to 6.6 μIU/mL) unlike the ST which showed significant increase (8.2 to 16.3 μIU/mL). The median of HOMA-IR after the intervention in GT showed lower levels than the ST (1.1 vs. 1.6, P=0.004). The median of b% only in ST showed significant increase from 38.2% at the baseline to 47.7% after the intervention. The mean of S% only in ST showed significant decrease after the intervention.      Conclusion: This study shows that the use of 150 ml infusion of green tea or sour tea, three times a day for four weeks, has positive effect on insulin resistance and certain lipoproteins in type 2 DM. Trial Registration Number: IRCT201107317161N1  PMID:25242840

  3. Efficacy of Aloe Vera Supplementation on Prediabetes and Early Non-Treated Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Zhang, Yiyi; Liu, Wen; Liu, Dan; Zhao, Tieyun; Tian, Haoming

    2016-06-23

    The aim of this study was to evaluate evidence for the efficacy of aloe vera on managing prediabetes and early non-treated diabetes mellitus. We performed a systematic search of PubMed, Embase, and Cochrane Central Register of Controlled Trials until 28 January 2016. A total of five randomized controlled trials (RCTs) involving 415 participants were included. Compared with the controls, aloe vera supplementation significantly reduced the concentrations of fasting blood glucose (FBG) (p = 0.02; weighed mean difference [WMD]: -30.05 mg/dL; 95% confidence interval [CI]: -54.87 to -5.23 mg/dL), glycosylated hemoglobin A1c (HbA1c) (p < 0.00001; WMD: -0.41%; 95% CI: -0.55% to -0.27%), triglyceride (p = 0.0001), total cholesterol (TC) (p < 0.00001), and low density lipoprotein-cholesterol (LDL-C) (p < 0.00001). Aloe vera was superior to placebo in increasing serum high density lipoprotein-cholesterol (HDL-C) levels (p = 0.04). Only one adverse event was reported. The evidence from RCTs showed that aloe vera might effectively reduce the levels of FBG, HbA1c, triglyceride, TC and LDL-C, and increase the levels of HDL-C on prediabetes and early non-treated diabetic patients. Limited evidence exists about the safety of aloe vera. Given the small number and poor quality of RCTs included in the meta-analysis, these results are inconclusive. A large-scale, well-designed RCT is needed to further address this issue.

  4. Efficacy of Aloe Vera Supplementation on Prediabetes and Early Non-Treated Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Zhang, Yiyi; Liu, Wen; Liu, Dan; Zhao, Tieyun; Tian, Haoming

    2016-01-01

    The aim of this study was to evaluate evidence for the efficacy of aloe vera on managing prediabetes and early non-treated diabetes mellitus. We performed a systematic search of PubMed, Embase, and Cochrane Central Register of Controlled Trials until 28 January 2016. A total of five randomized controlled trials (RCTs) involving 415 participants were included. Compared with the controls, aloe vera supplementation significantly reduced the concentrations of fasting blood glucose (FBG) (p = 0.02; weighed mean difference [WMD]: −30.05 mg/dL; 95% confidence interval [CI]: −54.87 to −5.23 mg/dL), glycosylated hemoglobin A1c (HbA1c) (p < 0.00001; WMD: −0.41%; 95% CI: −0.55% to −0.27%), triglyceride (p = 0.0001), total cholesterol (TC) (p < 0.00001), and low density lipoprotein-cholesterol (LDL-C) (p < 0.00001). Aloe vera was superior to placebo in increasing serum high density lipoprotein-cholesterol (HDL-C) levels (p = 0.04). Only one adverse event was reported. The evidence from RCTs showed that aloe vera might effectively reduce the levels of FBG, HbA1c, triglyceride, TC and LDL-C, and increase the levels of HDL-C on prediabetes and early non-treated diabetic patients. Limited evidence exists about the safety of aloe vera. Given the small number and poor quality of RCTs included in the meta-analysis, these results are inconclusive. A large-scale, well-designed RCT is needed to further address this issue. PMID:27347994

  5. Quality Control Measures over 30 Years in a Multicenter Clinical Study: Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study

    PubMed Central

    Arends, Valerie L.; Danis, Ronald P.; Diminick, Lisa; Klumpp, Kandace A.; Morrison, Anthony D.; Soliman, Elsayed Z.; Steffes, Michael W.; Cleary, Patricia A.

    2015-01-01

    Implementation of multicenter and/or longitudinal studies requires an effective quality assurance program to identify trends, data inconsistencies and process variability of results over time. The Diabetes Control and Complications Trial (DCCT) and the follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) study represent over 30 years of data collection among a cohort of participants across 27 clinical centers. The quality assurance plan is overseen by the Data Coordinating Center and is implemented across the clinical centers and central reading units. Each central unit incorporates specific DCCT/EDIC quality monitoring activities into their routine quality assurance plan. The results are reviewed by a data quality assurance committee whose function is to identify variances in quality that may impact study results from the central units as well as within and across clinical centers, and to recommend implementation of corrective procedures when necessary. Over the 30-year period, changes to the methods, equipment, or clinical procedures have been required to keep procedures current and ensure continued collection of scientifically valid and clinically relevant results. Pilot testing to compare historic processes with contemporary alternatives is performed and comparability is validated prior to incorporation of new procedures into the study. Details of the quality assurance plan across and within the clinical and central reading units are described, and quality outcomes for core measures analyzed by the central reading units (e.g. biochemical samples, fundus photographs, ECGs) are presented. PMID:26529311

  6. Additive Effect of Qidan Dihuang Grain, a Traditional Chinese Medicine, and Angiotensin Receptor Blockers on Albuminuria Levels in Patients with Diabetic Nephropathy: A Randomized, Parallel-Controlled Trial

    PubMed Central

    Xiang, Lei; Jiang, Pingping; Zhou, Lin; Sun, Xiaomin; Bi, Jianlu; Cui, Lijuan; Nie, Xiaoli; Luo, Ren; Liu, Yanyan

    2016-01-01

    Albuminuria is characteristic of early-stage diabetic nephropathy (DN). The conventional treatments with angiotensin receptor blockers (ARB) are unable to prevent the development of albuminuria in normotensive individuals with type 2 diabetes mellitus (T2DM). Purpose. The present study aimed to evaluate the effect of ARB combined with a Chinese formula Qidan Dihuang grain (QDDHG) in improving albuminuria and Traditional Chinese Medicine Symptom (TCMS) scores in normotensive individuals with T2DM. Methods. Eligible patients were randomized to the treatment group and the control group. Results. Compared with baseline (week 0), both treatment and control groups markedly improved the 24-hour albuminuria, total proteinuria (TPU), and urinary albumin to creatinine ratio (A/C) at 4, 8, and 12 weeks. Between treatment and the control group, the levels of albuminuria in the treatment group were significantly lower than in the control group at 8 and 12 weeks (p < 0.05). In addition, treatment group markedly decreased the scores of TCMS after treatment. Conclusion. This trial suggests that QDDHG combined with ARB administration decreases the levels of albuminuria and the scores for TCMS in normotensive individuals with T2DM. PMID:27375762

  7. Amitriptyline 2% cream vs. capsaicin 0.75% cream in the treatment of painful diabetic neuropathy (Double blind, randomized clinical trial of efficacy and safety).

    PubMed

    Kiani, Javad; Ahmad Nasrollahi, Saman; Esna-Ashari, Farzaneh; Fallah, Puyan; Sajedi, Firuzeh

    2015-01-01

    Because of less systemic side effects of topical medications in pain relief of the painful form of diabetic peripheral neuropathy, this study aimed to compare the effect of amitriptyline and capsaicin cream in relieving pain in this condition. In this randomized, double-blind and non -inferiority trial, 102 patients received amitriptyline 2% and capsaicin 0.75% creams 3 times a day for 12 weeks on the feet. Pain relief was measured by the visual analog scale (0-10). Treatment responding was considered as cure rate greater than 50% from baseline. Evaluations of the pain severity, compliance and drugs adverse effects were performed at each of the 4-week follow -up visits. Both drugs significantly relieved pain in 12 weeks compared with baseline values (P < 0.001 for both). Treatment responders were similar in both groups (P = 0.545). Intention-To-Treat analysis showed no significant difference in the efficacy between the two treatments (P = 0.703). Adverse events were more common in capsaicin group (P = 0.001). Dermatologic complications were the most common: itching, blister formation and erythema in the capsaicin group and skin dryness and itching in the amitriptyline group. This study demonstrates the similar efficacy of amitriptyline cream with capsaicin cream in managing diabetic neuropathic pain with fewer side effects.

  8. Successful recruitment and retention strategies for a randomized weight management trial for people with diabetes living in rural, medically underserved counties of South Carolina: the POWER study.

    PubMed

    Parra-Medina, Deborah; D'antonio, Angela; Smith, Sharon M; Levin, Sarah; Kirkner, Gregory; Mayer-Davis, Elizabeth

    2004-01-01

    We evaluated the feasibility of recruiting overweight adults with diabetes, living in rural, medically underserved communities, to a weight management intervention consisting of a 12-month clinical trial of two weight management programs and usual care. The sampling frame consisted of adults ages 45 years and older with clinically diagnosed diabetes from two community health centers. The recruitment process included medical record review, prescreening telephone call, two screening visits, and a randomization visit. Over 1,400 medical records were reviewed; 78.6% met eligibility criteria; 60.1% were contacted for telephone prescreening, and 35.5% remained eligible and were interested in participating. Of these, 187 completed visit 1, 164 completed visit 2, and 143 were randomized. Forty-six people were randomized who entered the study as walk-ins at screening visit 1, resulting in 189 subjects. The final yield was 21.5%. Subject mean age was 60.4 years, mean body mass index was 36.4 kg/m(2), 80% were African-American, and 46.6% had less than a high school education. Retention at 12 months was 81.5%. Successful strategies included partnering with community health centers, positive reinforcement and social supportiveness, monitoring progress, and free transportation. This work provides a useful example of an academic-community partnership designed to reach groups previously considered hard to reach.

  9. Interactive learning activities for the middle school classroom to promote healthy energy balance and decrease diabetes risk in the HEALTHY primary prevention trial.

    PubMed

    Venditti, Elizabeth M; Giles, Catherine; Firrell, L Suzanne; Zeveloff, Abigail D; Hirst, Kathryn; Marcus, Marsha D

    2014-01-01

    The HEALTHY trial evaluated the effectiveness of a multicomponent intervention program to reduce risk for type 2 diabetes in middle school students. The comprehensive intervention addressed nutrition, physical activity, and behavior in the context of a social marketing-based communications campaign to promote healthy energy balance. One element was a classroom-based program called FLASH (Fun Learning Activities for Student Health). Five FLASH modules were delivered, one per semester. Process evaluation data were collected from teachers at 21 schools and study staff at seven national sites via survey, interview, and in-class observation. Data from the first four modules were evaluated and showed that FLASH was delivered with high fidelity. Sessions that required peer interaction were rated as the most effective in engaging students and promoting knowledge. Study-provided material resources and on-site support were identified as key facilitators. Student misbehavior was viewed as the greatest barrier. Although the high level of support provided by the study is not likely to be replicated in school systems, those developing wellness policies, health curricula, and teacher training programs may benefit from using the evidence-supported, publicly available HEALTHY materials in their efforts to reduce diabetes risk factors in middle school youth.

  10. Interactive Learning Activities for the Middle School Classroom to Promote Healthy Energy Balance and Decrease Diabetes Risk in the HEALTHY Primary Prevention Trial

    PubMed Central

    Venditti, Elizabeth M.; Giles, Catherine; Firrell, L. Suzanne; Zeveloff, Abigail D.; Hirst, Kathryn; Marcus, Marsha D.

    2013-01-01

    The HEALTHY trial evaluated the effectiveness of a multicomponent intervention program to reduce risk for type 2 diabetes in middle school students. The comprehensive intervention addressed nutrition, physical activity, and behavior in the context of a social marketing–based communications campaign to promote healthy energy balance. One element was a classroom-based program called FLASH (Fun Learning Activities for Student Health). Five FLASH modules were delivered, one per semester. Process evaluation data were collected from teachers at 21 schools and study staff at seven national sites via survey, interview, and in-class observation. Data from the first four modules were evaluated and showed that FLASH was delivered with high fidelity. Sessions that required peer interaction were rated as the most effective in engaging students and promoting knowledge. Study-provided material resources and onsite support were identified as key facilitators. Student misbehavior was viewed as the greatest barrier. Although the high level of support provided by the study is not likely to be replicated in school systems, those developing wellness policies, health curricula, and teacher training programs may benefit from using the evidence-supported, publicly available HEALTHY materials in their efforts to reduce diabetes risk factors in middle school youth. PMID:23271717

  11. A Combination of Prebiotic Inulin and Oligofructose Improve Some of Cardiovascular Disease Risk Factors in Women with Type 2 Diabetes: A Randomized Controlled Clinical Trial

    PubMed Central

    Aliasgharzadeh, Akbar; Khalili, Mohammad; Mirtaheri, Elham; Pourghassem Gargari, Bahram; Tavakoli, Farnaz; Abbasalizad Farhangi, Mahdieh; Babaei, Hossein; Dehghan, Parvin

    2015-01-01

    Purpose: This trial was conducted to evaluate the effects of oligofructose-enriched inulin on some of cardiovascular disease risk factors in women with type 2 diabetes. Methods: 52 females (25diabetes were randomly assigned to two groups. Participants received 10g/d oligofructose-enriched inulin (n=27) or 10g/d placebo (n=25) for 8 weeks. Fasting blood samples were taken to measure metabolic profiles, malondialdehyd and antioxidant enzymes at baseline and after the 8 weeks intervention. Paired, unpaired sample t-test and analysis of covariance were used to comparison of quantitative variables. Results: After 8 weeks, in the oligofructose-enriched inulin group there was a significant increase in total antioxidant capacity (0.2 mmol/l, 20.0%) and a significant decrease in fasting plasma glucose (19.2 mg/dL, 9.4%) HbA1c (0.5%, 8.4%), total cholesterol (TC) (28.0 mg/dL, 14.1%), low-density lipoprotein cholesterol (LDL-c) (22.0 mg/dL, 21.7%), TC/HDL-c ratio (0.73, 20.7%), LDL-c/HDL-c ratio (0.55, 27.5%) and malondialdehyd (1.7 nmol/ml, 39.7%) compared to the placebo group. Changes in concentrations of triglycerides, high-density lipoprotein cholesterol (HDLc), superoxide dismutase, catalase and glutathione peroxidase were not significant in oligofructose-enriched inulin group compared to the placebo group. Conclusion: Oligofructose-enriched inulin may improve glycemic indices, lipid profile, antioxidant status and malondialdehyd in women with type 2 diabetes. PMID:26819923

  12. Effect of Improving Dietary Quality on Arterial Stiffness in Subjects with Type 1 and Type 2 Diabetes: A 12 Months Randomised Controlled Trial

    PubMed Central

    Petersen, Kristina S.; Clifton, Peter M.; Lister, Natalie; Keogh, Jennifer B.

    2016-01-01

    People with diabetes have accelerated arterial stiffening. The aim of this study was to determine the effect of increasing fruit, vegetable and dairy intake for 12 months on carotid femoral pulse wave velocity (cfPWV), augmentation index (AIx), and central blood pressure (cBP), compared to a usual diet control, in people with type 1 and type 2 diabetes. In a 12 months randomised controlled trial, cfPWV, AIx and cBP were measured every 3 months. The intervention group received dietary counselling to increase consumption of fruit (+1 serving/day; 150 g/day), vegetables (+2 servings/day; 150 g/day) and dairy (+1 serving/day; 200–250 g/day) at baseline, 1, 3, 6 and 9 months. The control group continued on their usual diet. One hundred and nine participants were randomised and 92 (intervention n = 45; control n = 47) completed. At 3 months, fruit (184 g/day; p = 0.001) and dairy (83 g/day; p = 0.037) intake increased in the intervention group compared with the control group but this increase was not maintained at 12 months. After adjustment for baseline measurements there was no time by treatment effect for central systolic or diastolic BP, AIx or cfPWV. A time effect existed for AIx which modestly increased over time. Peripheral diastolic BP and central pulse pressure were improved in the intervention group compared with the control group at 12 months. In the cohort with type 1 and type 2 diabetes, improving dietary quality by increasing consumption of fruit, vegetables and dairy did not improve cBP, AIx or cfPWV, compared with a control group continuing on their usual diet, after 12 months. PMID:27338467

  13. Effects of a T-type calcium channel blocker, ABT-639, on spontaneous activity in C-nociceptors in patients with painful diabetic neuropathy: a randomized controlled trial.

    PubMed

    Serra, Jordi; Duan, W Rachel; Locke, Charles; Solà, Romà; Liu, Wei; Nothaft, Wolfram

    2015-11-01

    T-type calcium channels are a potential novel target for treatment of neuropathic pain such as painful diabetic neuropathy. ABT-639 is a peripherally acting highly selective T-type Ca(v)3.2 calcium channel blocker that has demonstrated analgesic efficacy in preclinical models and may have the potential to reduce spontaneous fiber activity. Microneurography is a unique technique that directly assesses the function of peripheral sensory afferents and measures abnormal spontaneous activity in single peripheral nociceptive C fibers. Abnormal spontaneous activity in C-nociceptors functions as a marker for spontaneous pain, as reduction of this activity could indicate analgesic efficacy. This randomized, double-blind controlled study evaluated the effects of a single 100-mg oral dose of ABT-639, compared with placebo, on abnormal spontaneous activity in peripheral C-nociceptors, measured for the first time by microneurography in adult patients with painful diabetic neuropathy. Lidocaine was included in this study and compared with placebo. Pharmacokinetics and safety of ABT-639 were evaluated. Thirty-nine patients were randomized, and a total of 56 analyzable C-nociceptors with spontaneous activity were identified in 34 patients. There were no significant differen