Type 2 Diabetes Mellitus Outcomes Research Articles

Effects of curcumin on glycemic control and lipid profile in prediabetes and type 2 diabetes mellitus: A systematic review and meta-analysis.

ScopeStudies have demonstrated inconsistent effects of curcumin on glycemic outcomes and lipid parameters in patients with prediabetes and type 2 diabetes mellitus (T2DM). This study aimed to assess the effect of curcumin on glycemic control and lipid profile in prediabetes and T2DM.Methods and resultsA systematic search of randomized controlled trials (RCTs) was conducted from inception to June 2018 in electronic sources including AMED, ANZCTR, BioMed Central, CENTRAL, CINAHL, ClinicalTrials.gov, Expanded Academic Index, Google Scholar, ISRCTN, LILACS, MEDLINE, NCCIH, Science Direct, Scopus, Web of Science, and WHO ICTRP. Hand search was also performed. Of the total 486 records, four trials (N = 508) and eight trials (N = 646) were eligible for the meta-analysis of individuals with prediabetes and T2DM, respectively. Curcumin significantly reduced glycosylated hemoglobin (HbA1c) in prediabetics (MD: -0.9%, 95% CI: -1.7 to -0.1%, p = 0.03). Furthermore, T2DM subjects gained favorable reduction in both HbA1c (MD: -0.5%, 95% CI: -1.0 to -0.0%, p = 0.04) and fasting plasma glucose (MD: -11.7 mg/dL, 95% CI: -22.1 to -1.3 mg/dL, p = 0.03). Tendency of lipid profile improvement was also observed.ConclusionOur findings may encourage curcumin supplementation based on its meaningful effect on glycemic control and positive trend on lipid outcomes in prediabetes and T2DM.

CANadian CAnagliflozin REgistry: Patient-Reported Outcomes of Canagliflozin in the Treatment of Type 2 Diabetes Mellitus in Canadian Clinical Practice.

To describe patient-reported outcomes (PROs) after initiation of treatment with canagliflozin (CANA) for type 2 diabetes mellitus (T2DM) in a real-world Canadian setting. CANadian CAnagliflozin REgistry (CanCARE) is a prospective, observational, single-arm, real-world Canadian study of the effectiveness and safety of CANA for the treatment of T2DM in 527 subjects. PRO measures were collected in CanCARE using the Current Health Satisfaction Questionnaire (CHES-Q) at baseline and after 3, 6 and 12months of CANA treatment to examine patient satisfaction regarding weight and overall health. Associations between changes in satisfaction with weight, systolic blood pressure (SBP) and glycated hemoglobin (A1C) levels were also investigated. Proportion of patients satisfied with their body weight and overall health increased from 22.1% and 26.9% at baseline to 32.4% and 49.2% after 12months of CANA treatment, respectively. Satisfaction rates also increased on CHES-Q domains representing physical and emotional health. Correlations were found between improvement in satisfaction with body weight and weight loss (r=-0.29; p<0.01) and between improvements in satisfaction with overall health and weight loss (r=-0.13; p=0.03) and SBP (r=-0.17; p<0.01), but not with changes in A1C level. Treatment with CANA is associated with improvements in satisfaction with body weight and overall health, which may be important drivers of patient self-management and hold the potential to positively influence long-term outcomes in T2DM.

Review of the cardiovascular safety of dipeptidyl peptidase-4 inhibitors and the clinical relevance of the CAROLINA trial

BackgroundCardiovascular (CV) disease (CVD) is a well-recognized complication of type 2 diabetes mellitus (T2DM) and there is a clinical need for glucose-lowering therapies that do not further increase CV risk in this population. Although sulfonylureas (SUs) may be used as second-line therapy for patients requiring additional therapy after first-line metformin to improve glycemic control, their long-term effects on CV outcomes remain uncertain, and a wide range of alternative agents exist including dipeptidyl peptidase-4 (DPP-4) inhibitors.MethodsLiterature searches in PubMed (2013–2018) were conducted with terms for DPP-4 inhibitors combined with CV terms, with preference given to cardiovascular outcomes trials (CVOTs). Reference lists from retrieved articles and diabetes guidelines were also considered.ResultsThis narrative review discusses current evidence for the CV safety of these agents, describes the long-term CV effects of DPP-4 inhibitors, including effects on CV events, mortality, the risk for heart failure hospitalization, and highlights the need for further research into the CV effects of SU therapy. Although SUs remain a treatment option for T2DM, the long-term effects of these agents on CV outcomes are unclear, and further long-term studies are required. For DPP-4 inhibitors, uncertainties have been raised about their long-term effect on hospitalization for heart failure in light of the results of SAVOR-TIMI 53, although the findings of other DPP-4 inhibitor CVOTs in T2DM and data analyses have suggested these agents do not increase the occurrence of adverse CV outcomes.ConclusionsBased on recent CVOTs and guideline updates, the choice of add-on to metformin therapy for patients with T2DM and established CV disease should be a sodium-glucose co-transporter-2 inhibitor or a glucagon-like peptide-1 agonist with proven CV benefit. Additional treatment options for those individuals who require therapy intensification, as well as in patients with T2DM and without established CVD include DPP-4 inhibitors and SUs. Since few head-to-head trials have compared the effects of different oral glucose-lowering agents on CV outcomes in T2DM, with most CVOTs using placebo as a comparator, the CAROLINA trial will provide important information on the comparative CV safety of a commonly prescribed SU and a DPP-4 inhibitor.

Abstract P077: Glucagon-Like Peptide-1 Receptor Agonists and Cardiovascular Outcomes in Black Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Recent Cardiovascular Outcome Trials

Introduction: The prevalence of type 2 diabetes mellitus (T2DM) is higher in black individuals than non-Hispanic white individuals. Recent cardiovascular (CV) outcome trials have demonstrated CV benefit of glucagon-like peptide 1 (GLP-1) receptor agonists in patients with T2DM and high CV risk. Whether the benefit seen in the overall trial population extends to the subgroup of black individuals is not known given the limited sample size. Methods: We performed a meta-analysis of randomized CV outcome trials published after the issuance of Food and Drug Administration Guidance on antihyperglycemic medications in 2008. Results: Five trials assessing the CV benefit of GLP-1 receptor agonists in T2DM were identified (ELIXA, LEADER, SUSTAIN-6, EXSCEL, and HARMONY). ELIXA was excluded given the different primary outcome studied and the lack of complete outcome data by race. The four trials included in this meta-analysis enrolled 36,852 individuals, including 2,101 black participants (6%). The prevalence of black patients in the individual clinical trials ranged from 2% in the HARMONY trial to 8% in the LEADER trial. The composite primary outcome of CV death, non-fatal MI, or non-fatal stroke was recorded in 114 out of 1,031 black patients (11%) treated with a GLP-1 analogue compared to 136/1070 (13%) treated with placebo (Hazard Ratio 0.96, 95% Confidence Interval 0.57-1.62). The test for heterogeneity was significant (p=0.04). Conclusions: Despite the high prevalence of T2DM in black individuals, they remain underrepresented in the clinical trials assessing the effect of GLP-1 receptor agonists on CV outcomes in T2DM. The results of this meta-analysis suggest heterogeneity in the studies that have been performed to date. Future studies are needed to confirm the benefit of GLP-1 receptor agonists in black individuals with T2DM and high CV risk. Figure: Hazard ratios of cardiovascular death, non-fatal MI, or non-fatal stroke in black patients with diabetes type 2 treated with a glucagon-like peptide-1 analogue versus placebo

Insights on Medical Nutrition Therapy for Type 2 Diabetes Mellitus: An Indian Perspective.

It is critical to integrate medical nutrition therapy (MNT) provided by a registered dietician (RD) into primary care of type 2 diabetes mellitus (T2DM). This is necessary to achieve the goals of improving overall metabolic measures beyond calorie restriction and weight loss. Misconceptions about nutrition in T2DM add to the challenges of executing MNT in a culturally sensitive population. The current review provides insights into MNT for the prevention and management of T2DM in India, based on both evidence and experience. It revisits historical Indian studies and provides information on appropriate dietary intake of carbohydrates (60–70%), proteins (~ 20%) and fats (10%) that will be acceptable and beneficial in an Indian T2DM population. It discusses nuances of types of carbohydrates and fats and explains associations of increased dietary fiber intake, balanced intake of low and high glycemic index foods and substitution of saturated fats with plant-based polyunsaturated fats in improving outcomes of T2DM and attenuating risk factors. The article also deliberates upon special patient populations with comorbid conditions and diseases and the necessary adjustments needed in their nutritional care. It outlines a step-wise approach to MNT involving a careful interplay of nutrition assessment, diagnosis, individualization and patient counseling. Overall, the success of MNT relies on providing accurate, acceptable and appropriate dietary choices for continued patient adherence. Collaborative efforts from diabetologists, endocrinologists, internists and RDs are required to prioritize and implement MNT in diabetes practice in India.Funding: Signutra Inc.

Suboptimal health status as an independent risk factor for type 2 diabetes mellitus in a community-based cohort: the China suboptimal health cohort study.

The prevalence of diabetes, constituted chiefly by type 2 diabetes mellitus (T2DM), is a global public health threat. Suboptimal health status (SHS), a physical state between health and disease, might contribute to the progression or development of T2DM. We conducted a prospective cohort study, based on the China Suboptimal Health Cohort Study (COACS), to understand the impact of SHS on the progress of T2DM. We examined associations between SHS and T2DM outcomes using multivariable logistic regression models and constructed predictive models for T2DM onset based on SHS. A total of 61 participants developed T2DM after an average of 3.1years of follow-up. Participants with higher SHS scores had more T2DM outcomes (p =0.036). Moreover, compared with the lowest quartile of SHS scores, participants with fourth, third, and second quartile SHS scores were found to be associated with a 1.7-fold, 1.6-fold, and 1.5-fold risk of developing T2DM, respectively. The predictive model constructed with SHS had higher discriminatory power (AUC = 0.848) than the model without SHS (AUC = 0.795). The present study suggests that a higher SHS score is associated with a higher incidence of T2DM. SHS is a new independent risk factor for T2DM and has the capability to act as a predictive tool for T2DM onset. The evaluation of SHS combined with the analysis of modifiable risk factors for SHS allows the risk stratification of T2DM, which may consequently contribute to the prevention of T2DM development. These findings might require further validation in a longer-term follow-up study.

Use of a Metabolic Syndrome Severity Z Score to Track Risk During Treatment of Prediabetes: An Analysis of the Diabetes Prevention Program.

OBJECTIVEWe assessed whether changes in metabolic syndrome (MetS) severity during the treatment of prediabetes are associated with reduced risk of type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD).RESEARCH DESIGN AND METHODSWe analyzed data from the Diabetes Prevention Program (DPP) for 2,476 adults in 1996–1999 with prediabetes randomized to receive treatment with lifestyle modification, metformin, or placebo for 2–3 years and followed through 2014 for T2DM and CVD outcomes. We calculated effect sizes from baseline in a MetS severity z score (MetS-Z) and the individual MetS components, and assessed relationships between 1-year effect size and incident T2DM and CVD using hazard ratios (HRs) and mediation analysis.RESULTSBaseline MetS-Z and its components were associated with risk of incident T2DM and CVD. During year 1 of intervention, MetS-Z and its components decreased most with lifestyle modification, followed by treatment with metformin and placebo. Risk of T2DM within 1–5 years was most strongly associated with 1-year changes in MetS-Z and waist circumference (both HRs for a 1 SD increase = 1.80), whereas the risk of CVD was associated with a 1-year change in MetS-Z, glucose, and systolic blood pressure. In mediation analyses, the effect of lifestyle modification on T2DM risk was mediated by 1-year changes in MetS-Z, waist circumference, glucose, and triglycerides, whereas the effect of metformin was mediated by MetS-Z and glucose.CONCLUSIONSChanges in these risk indicators of MetS severity during intervention in the DPP reflect altered disease risk and may help in tracking earlier responses to treatment and in motivating patients.

Baseline Vitamin D as a Surrogate Marker for Type 2 Diabetes Remission and Weight Loss following Sleeve Gastrectomy

Background: Vitamin D deficiency is associated with obesity and type 2 diabetes mellitus (T2DM), although the use of circulating Vitamin D levels as a predictor of weight loss induced T2DM remission is unclear. Therefore, the aim of this study was to analyze whether pre-bariatric surgery vitamin D levels may predict T2DM outcomes 12 months post-SG. Method: A cohort of 220 obese participants (74.5% female) with T2DM (Age: 50±9.5yr, BMI: 51.4±7Kg/m2; n=103) and without T2DM (Age: 46±9yr, BMI: 53.5±6.5Kg/m2; n=117) undergoing SG participated in an ethics approved study in a single bariatric centre in the UK. Patient anthropometric and biochemical data including vitamin D were collected at baseline and 12 months post-SG; no vitamin D supplementation at baseline was given. Results: Baseline vitamin D levels inversely correlated with baseline BMI (P&amp;lt;0.001, r=-0.35). Age, pre-op weight loss and vitamin D levels were correlated with HbA1c 12 months post-SG (P&amp;lt;0.001, r=0.28, P&amp;lt;0.001, r=-0.25 and P&amp;lt;0.05, r=-0.19). Furthermore, baseline vitamin D levels predicted levels of HbA1c post-surgery following adjustment for pre-op weight loss and age. Within the T2DM group, those that achieved T2DM remission 12 months post-SG (49.5%; n=51) had a higher baseline vitamin D compared to those not in remission (43.5±23.8 vs. 33±19nmol/L; P&amp;lt;0.05), with no significant differences between the two groups in baseline BMI, hypertension, pre-op weight loss or excess weight loss (EWL). Interestingly, patients with higher pre-surgical Vitamin D levels also had significantly lower BMI (P&amp;lt;0.005) and higher % EWL (P&amp;lt;0.05) 12 months post-surgery. Conclusion: Baseline Vitamin D levels appear to be an independent indicator for successful T2DM remission and weight loss, 12 months following SG. The use of baseline Vitamin D levels may help us predict those more likely to do well and prioritize post-surgery support to achieve success for all participant groups. Disclosure A. Aladel: None. M.K. Piya: None. S. Azharian: None. M. Christian: None. V. Menon: None. P.G. McTernan: None.

Social Network Characteristics Are Associated With Type 2 Diabetes Complications: The Maastricht Study.

The relation between clinical complications and social network characteristics in type 2 diabetes mellitus (T2DM) has hardly been studied. Therefore, we examined the associations of social network characteristics with macro- and microvascular complications in T2DM and investigated whether these associations were independent of glycemic control, quality of life, and well-known cardiovascular risk factors. Participants with T2DM originated from the Maastricht Study, a population-based cohort study (n = 797, mean age 62.7 ± 7.6 years, 31% female). Social network characteristics were assessed through a name generator questionnaire. Diabetes status was determined by an oral glucose tolerance test. Macro- and microvascular complications were defined as a history of cardiovascular disease and the presence of impaired vibratory sense and/or retinopathy and/or albuminuria, respectively. We assessed cross-sectional associations of social network characteristics with macro- and microvascular complications by use of logistic regression adjusted for age, HbA1c, quality of life, and cardiovascular risk factors, stratified for sex. A smaller network size, higher percentages of family members, and lower percentages of friends were independently associated with macrovascular complications in both men and women. A smaller network size and less informational support were independently associated with microvascular complications in women, but not in men. This study shows that social network characteristics were associated with macro- and microvascular complications. Health care professionals should be aware of the association of the social network with T2DM outcomes. In the development of strategies to reduce the burden of disease, social network characteristics should be taken into account.

Real-World Challenges in Type 2 Diabetes Mellitus: Why a Paradigm Shift Is Needed

Despite the increasing range of treatment options for patients with Type 2 diabetes mellitus (T2DM), there are a number of real-world barriers that prevent many patients from achieving and maintaining glycaemic control. The objective of this symposium was to provide an overview of the challenges in T2DM treatment and to discuss novel strategies that may overcome these issues. The symposium started by exploring the key barriers that prevent patients from achieving glycaemic control, highlighting patient non-adherence to treatment as the major contributor to poor glycaemic control in a real-world setting. The speakers then explored the issue of non-adherence further, focussing on patient and physicianrelated contributing factors, including patient perceptions of treatment value and burden, fears of hypoglycaemia, and patient–physician interactions. The symposium ended with a presentation on potential strategies to improve treatment adherence and clinical outcomes in T2DM. Clinical evidence was presented suggesting that effective methods for helping patients to attain and maintain glycaemic control include both early treatment with intensive combination therapy and treatment with fixed-dose combinations of a glucagon-like peptide 1 (GLP-1) receptor agonist and a basal insulin analogue (iDegLira and iGlarLixi). Novel drug delivery methods were highlighted as a potential strategy for improving patient adherence and treatment success, with data presented on the efficacy and safety of ITCA 650 (Intarcia Therapeutics Inc., Boston, Massachusetts, USA), a subdermal osmotic mini-pump that provides continuous delivery of a GLP-1 receptor agonist. The symposium concluded with a summary of the main points, in which the need for new strategies to address the issue of non-adherence to therapy in T2DM was emphasised.

A Retrospective Study of Medication Utilization Pattern and Clinical Outcome in Middle-Aged and Older Patients with Type 2 Diabetes Mellitus in Qatar

Background: Type 2 Diabetes Mellitus (T2DM) is generally a costly illness and related to significant mortality and morbidity. In spite of this, there is only little information available on clinical outcome and ‘real-world’ medication utilization patterns for middle age and older patients with T2DM. Therefore, the main aim of the study is to evaluate the Medication Utilization Pattern and Clinical outcomes of T2DM for middle age and older patients. Methods: A retrospective longitudinal study was conducted for a period of six months after getting approval from a medical research center (IRB No #15175) in an out-patient department of a tertiary hospital in Doha, Qatar. The outpatients with T2DM, around 60 years of age were included in the study. The sample size for the study was 150 middle-aged and older patients from a total of 800 patients who attended Rumailah hospital Geriatric outpatient clinic during the study period. The gathered data was stored with identifier code in the shared drive for 2 years after the completion of study for verification purpose and future studies if any; it was shared with all internal collaborators. The gathered data was analyzed using SPSS v2.0 (Statistical Package for Social Sciences version 20 Inc. USA). The method for the analysis was continuous variable analysis using student t-test or one-way ANOVA, for skewed continuous data, a non-parametric Mann-Whitney test, and categorical variables were compared using chi-square test and the associations between DM, socio-demographic and clinical indicators were evaluated. Results: The results show that the combination of anti-diabetic therapy was more used than monotherapy. The study found a slight but significant positive correlation between age and HbA1C in addition to Fasting Blood Sugar (FBS) and Glycated hemoglobin (HbA1c) levels. Under different treatment regimens, a majority of 118 older patients were using Metformin; for insulin, the most commonly used treatment regimen is Glargine Insulin; with regards to anti-hypertensive, Amlodipine is the most prescribed medication for patients followed by Beta Blocker, as Metoprolol. The use of a combination of Metformin/Sitagliptin or Vildagliptin showed higher Non-Insulin Anti-Diabetic (NIAD) drug prescriptions as per the target attained between HbA1c which was 7.0 to 8.0% in healthy older patients. Conclusion: In a large cohort of patients with DM, an overall satisfactory quotient was achieved in treatment quality; however, applicable proportions of patients had below or above the target range of recommended HbA1C values. The fundamental treatment patterns varied from general diabetes with an extraordinarily higher percentage and more than 50 percentage getting insulin-based therapies which were related to high probability of HbA1C levels >7%.

Diabetes Mellitus Management Among Patients with Limited English Proficiency: A Systematic Review and Meta-Analysis.

Patients with limited English proficiency (LEP) and type 2 diabetes mellitus (T2DM) have several health disparities, including suboptimal patient-provider interactions, poorer glycemic control, and T2DM complications. Understanding existing interventions for improving T2DM outcomes in this population is critical for reducing disparities. We performed a systematic review of randomized controlled trials (RCTs) and observational studies examining the effectiveness of interventions in improving T2DM outcomes among patients with LEP in North America. Quality was assessed using the Cochrane risk of bias tool for RCTs and the Newcastle-Ottawa Scale for non-RCT studies. Meta-analysis was conducted using the random-effects model. Fifty-four studies, 39 of which reported sufficient data for meta-analysis of glycemic control, were included. The interventions were associated with a statistically significant reduction in hemoglobin A1c (HbA1c) (weighted difference in means, -0.84% [95% CI, -0.97 to -0.71]) that was, however, very heterogeneous across studies (I2= 95.9%). Heterogeneity was explained by study design (lower efficacy in RCTs than non-RCTs) and by intervention length and delivery mode (greater reduction in interventions lasting <6months or delivered face-to-face); P < 0.05 for all three covariates. The interventions were also associated in most studies with improvement in knowledge, self-efficacy in diabetes management, quality of life, blood pressure, and low-density lipoprotein cholesterol. Multiple types of interventions are available for T2DM management in patients with LEP. Multicomponent interventions delivered face-to-face seem most effective for glycemic control. More research is needed to better understand other aspects of multicomponent interventions that are critical for improving important outcomes among patients with T2DM and LEP.

The Cost-effectiveness of Dulaglutide 1.5mg versus Exenatide QW for the Treatment of Patients with Type 2 Diabetes Mellitus in France.

IntroductionDulaglutide is a novel onceweekly administered glucagon-like peptide 1 receptor agonist (GLP-1 RA) for the management of type 2 diabetes mellitus (T2DM). The objective of this analysis was to estimate the cost-effectiveness of dulaglutide 1.5 mg versus exenatide QW for the management of T2DM in France.MethodsThe QuintilesIMS CORE Diabetes Model was used to estimate the expected lifetime direct medical costs and outcomes of T2DM from the perspective of the French National Health Service. In the absence of head-to-head data, relative efficacy was derived from a network meta-analysis. Patient cohort characteristics were derived from the AWARD-2 trial. All patients were assumed to remain on treatment for 2 years before escalating to insulin therapy. Costs included treatment costs and costs associated with long-term complications of T2DM. Utilities were estimated based on a recent systematic review. One-way sensitivity analyses (OWSA) and probabilistic sensitivity analysis (PSA) were conducted. Cost-effectiveness acceptability curves (CEACs) were generated.ResultsDulaglutide 1.5 mg was associated with lower costs (lifetime costs €41,562 vs €43,021) and increased health benefits (lifetime quality-adjusted life years: QALYs 9.804 vs 9.757) versus exenatide QW for the treatment of T2DM in France. OWSA and PSA indicated that results were robust across a range of plausible input parameters. The CEAC indicated a 99.5% probability that dulaglutide would be considered cost-effective at a willingness to pay of €30,000.ConclusionDulaglutide 1.5 mg reduced expected costs and increased expected QALYs when compared against exenatide QW for the treatment of T2DM in France. Compared with exenatide QW, dulaglutide 1.5 mg can provide additional health benefits for patients with T2DM and may result in cost savings for payers.FundingEli Lilly.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-017-0321-0) contains supplementary material, which is available to authorized users.

Impact of Type 2 Diabetes Mellitus on Survival in Head and Neck Squamous Cell Carcinoma.

Objective To identify any association between type 2 diabetes mellitus (T2DM) and survival outcomes for mucosal squamous cell carcinoma of the head and neck. An association has been demonstrated between T2DM and cancer outcomes at numerous sites, but data for the head and neck are limited. Improving our understanding of the impact that diabetes has on head and neck cancer survival is relevant for making treatment decisions and counseling patients regarding prognosis. Study Design Retrospective cohort study. Setting Academic tertiary referral head and neck cancer center. Subjects and Methods By accessing data retrospectively from prospectively collected databases at the Princess Margaret Cancer Centre, patients were studied who were treated for mucosal head and neck squamous cell cancer between January 2005 and December 2011. Collection of clinical, pathologic, and survival data was completed with an emphasis on T2DM. Results Of 2498 patients identified in the study period, 319 (12.8%) had T2DM. Five-year overall survival was not different between the diabetic (64%, 95% CI = 58%-71%) and nondiabetic (67%, 95% CI = 65%-69%; P = .078) groups. Furthermore, cause-specific survival did not demonstrate a statistically significant difference between groups (diabetic: 84%, 95% CI = 79%-88%, vs nondiabetic: 84%, 95% CI = 82%-86%; P = .67). Conclusion Despite contradictory evidence at other cancer sites, the presence of T2DM alone does not appear to adversely affect cancer survival outcomes in head and neck squamous cell cancer. This is encouraging for the diabetic patients with head and neck squamous cell cancer, and it provides guidance for the multidisciplinary team that treats them.

Validating Health Literacy and Numeracy Measures in Minority Groups.

Background:Validation studies of existing health literacy or numeracy tools among racial/ethnic minorities are limited.Objective:This study assessed the validity of the Subjective Numeracy Scale (SNS), the Diabetes Numeracy Test (DNT-5), the Brief Health Literacy Screen (BHLS), and the Short Test of Functional Health Literacy in Adults (S-TOFHLA) by trait (health literacy or numeracy) and by method (subjective or objective) among non-Hispanic white (NHW), non-Hispanic black (NHB), and Hispanic patients with type 2 diabetes mellitus (T2DM).Methods:We conducted a secondary analysis of baseline data from the Partnering to Improve Diabetes Education (PRIDE) study, a clustered randomized controlled trial testing the efficacy of a health communication intervention on T2DM outcomes at state Department of Health clinics in middle Tennessee. PRIDE participants with race/ethnicity data available (n = 398) were included in this study. Most patients identified as NHW (59%), 18% identified as NHB, and 23% identified as Hispanic. Pearson correlations among the 4 measures were compared for each racial/ethnic group by trait and method. The convergent validity of each measure with education was also assessed using Pearson correlation analyses.Key Results:Significant correlations were observed across all 3 subgroups for the numeracy measures (SNS and DNT-5) and the objective measures (DNT-5 and S-TOFHLA). Nonsignificant correlations were observed among Hispanic participants for the health literacy measures (BHLS and S-TOFHLA, correlation coefficient = 0.13) and among NHB and Hispanic participants for the subjective measures (SNS and BHLS, correlations coefficients = 0.15 and 0.09, respectively). A significant positive correlation was noted between education and each measure across all 3 subgroups.Conclusions:Subjective and health literacy measures demonstrate weaker correlations than objective and numeracy measures, respectively, among minority patients in this study. Our findings highlight the need to further evaluate the appropriateness of these tools for use with minority populations, particularly the BHLS for Hispanic patients. [Health Literacy Research and Practice. 2017;1(2):e23–e30.]Plain Language Summary:Few studies have tested the validity of health literacy and numeracy measures in minority groups. This study highlights racial/ethnic differences in the results of validity testing of the Subjective Numeracy Scale, the Diabetes Numeracy Test, the Brief Health Literacy Screen, and the Short Test of Functional Health Literacy in Adults among adults with type 2 diabetes.

Impact of bromocriptine-QR therapy on cardiovascular outcomes in type 2 diabetes mellitus subjects on metformin

ABSTRACTObjectives: Type 2 diabetes mellitus (T2DM) is associated with a substantially increased risk of cardiovascular disease (CVD). Bromocriptine-QR (B-QR), a quick release sympatholytic dopamine D2 receptor agonist, is a FDA-approved therapy for T2DM which may provide CVD risk reduction. Metformin is considered to be an agent with a potential cardioprotective benefit. This large placebo controlled clinical study assessed the impact of B-QR addition to existing metformin therapy on CVD outcomes in T2DM subjects.Methods: 1791 subjects (1208 B-QR; 583 placebo) on metformin ± another anti-diabetes therapy at baseline derived from the Cycloset Safety Trial, a 12-month, randomized, multicenter, placebo-controlled, double-blind study in T2DM, were included in this study. The primary CVD endpoint evaluated was treatment impact on CVD event rate, prespecified as a composite of time to first myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina/congestive heart failure. Impact on glycemic control was evaluated as a secondary analysis.Results: The composite CVD end point occurred in 16/1208 B-QR treated (1.3%) and 18/583 placebo treated (3.1%) subjects resulting in a 55% CVD hazard risk reduction (intention-to-treat, Cox regression analysis; HR: 0.45 [0.23–0.88], p = 0.028). Kaplan-Meier curves demonstrated a significantly lower cumulative incidence rate of the CVD endpoint in the B-QR treatment group (Log-Rank p = 0.017). In subjects with poor glycemic control (HbA1c ≥ 7.5) at baseline, B-QR therapy relative to placebo resulted in a significant mean %HbA1c reduction of −0.59 at week 12 and −0.51 at week 52 respectively (p < 0.001 for both) and a 10 fold higher percent of subjects achieving HbA1c goal of ≤7% by week 52 (B-QR 30%, placebo 3%; p = 0.003).Conclusion: These findings suggest that in T2DM subjects on metformin, BQR therapy may represent an effective strategy for reducing CVD risk.Cycloset Safety Trial registration: ClinicalTrials.gov Identifier: NCT00377676.

Psychological Interventions for the Management of Glycemic and Psychological Outcomes of Type 2 Diabetes Mellitus in China: A Systematic Review and Meta-Analyses of Randomized Controlled Trials.

China has the largest number of type 2 diabetes mellitus (T2DM) cases globally, and T2DM management has become a critical public health issue in China. Individuals with T2DM have an increased risk of developing mental health disorders, psychological disturbances, and functional problems associated with living with their condition. Previous systematic reviews have demonstrated that, generally, psychological interventions are effective in the management of T2DM-related outcomes; however, these reviews have predominantly included studies conducted within English-speaking countries and have not determined the efficacy of the varying types of psychological interventions. As such, this paper aims to synthesize evidence and quantify the efficacy of psychological therapies for the management of glycemic and psychological outcomes of T2DM in China, relative to control conditions. A systematic search (MEDLINE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, and Wangfang Data) for all years to December 2014 identified all available literature. Eligibility criteria included: peer-reviewed journal articles, randomized controlled trials (RCTs) assessing the efficacy of a psychological therapy for the management of T2DM, adult participants (≥18 years) diagnosed with T2DM or non-insulin-dependent diabetes mellitus, and Chinese speaking participants only (in mainland China). Outcome measures were glycated hemoglobin, blood glucose concentration, depression, anxiety, and quality of life. Effect sizes were pooled using a random effects model. Negative effect sizes corresponded to positive outcomes favoring the intervention. Forty-five RCTs were eligible for the meta-analyses. Cognitive behavioral therapy (CBT) and motivational interviewing (MI) were more effective than the control condition in the reduction of glycated hemoglobin [CBT: -0.97 (95% CI -1.37 to -0.57); MI: -0.71 (95% CI -1.00 to -0.43)]. CBT and client-centered therapy (CCT) were also associated with reductions in depression and blood glucose concentration, and CBT was associated with reductions in anxiety. Psychological interventions, namely, CBT, MI, and CCT are effective in improving certain T2DM-related outcomes in China. Considerable levels of heterogeneity and unclear risk of bias associated with most included RCTs suggest caution when interpreting results. In China, where the burden of T2DM is increasing significantly, psychological interventions may provide promising approaches to assist in the management of T2DM to delay the progression of T2DM related outcomes.

A randomised trial comparing low-fat diets differing in carbohydrate and protein ratio, combined with regular moderate intensity exercise, on glycaemic control, cardiometabolic risk factors, food cravings, cognitive function and psychological wellbeing in adults with type 2 diabetes: Study protocol

Hypocaloric low-fat diets, high in protein with moderate carbohydrate (HP) can enhance weight loss, improve glycaemic control and improve cardiometabolic health risk factors in type 2 diabetes mellitus (T2DM). However, it is unclear whether the metabolic benefits observed during weight loss are sustained during energy-balance and weight maintenance. Furthermore, there is a lack of evidence regarding the effect of HP diets on food cravings, cognitive function and psychological wellbeing in T2DM, despite carbohydrate food cravings, cognitive impairment and depression being associated with hyperglycaemia. Overweight/obese adults with T2DM were randomised to consume either a HP diet (n=32, ~32% protein, 33% carbohydrate, 30% fat) or a higher-carbohydrate diet (HC, n=29, ~22% protein, 51% carbohydrate, 22% fat) for 24 weeks with 30 min of moderate intensity exercise five days/week for the study duration. There were 2 phases: a 12 week weight loss phase followed by a 12 week weight maintenance phase. Primary outcome was glycaemic control (glycosylated haemoglobin; HbA1c). Secondary outcomes were cardiometabolic risk factors (body composition, fasting blood pressure, blood lipids, glucose, insulin and C-reactive protein), food cravings, cognitive function (memory; psychomotor and executive function and psychological well-being. Outcomes were measured at baseline and the end of each 12-week intervention phase. Data will be analysed as intention-to-treat using linear mixed effects models. This study will examine the effects of two dietary interventions on health outcomes in T2DM during weight loss and notably following weight maintenance where there is a paucity of evidence.

The “Sapienza University Mortality and Morbidity Event Rate (SUMMER) study in diabetes”: Study protocol

Background and aimsThe rate of mortality in diabetic patients, especially of cardiovascular origin, is about twice as much that of nondiabetic individuals. Thus, the pathogenic factors shaping the risk of mortality in such patients must be unraveled in order to target intensive prevention and treatment strategies. The “Sapienza University Mortality and Morbidity Event Rate (SUMMER) study in diabetes” is aimed at identifying new molecular promoters of mortality and major vascular events in patients with type 2 diabetes mellitus (T2DM). Methods/designThe “SUMMER study in diabetes” is an observational, prospective, and collaborative study conducted on at least 5000 consecutive patients with T2DM, recruited from several diabetes clinics of Central–Southern Italy and followed up for a minimum of 5 years. The primary outcome is all-cause mortality; the secondary outcomes are cardiovascular mortality, acute myocardial infarction, stroke, and dialysis. A biobank will be created for genomic, transcriptomic, and metabolomic analysis, in order to unravel new molecular predictors of mortality and vascular morbidity. DiscussionThe “SUMMER study in diabetes” is aimed at identifying new molecular promoters of mortality and major vascular events in patients with T2DM. These novel pathogenic factors will most likely be instrumental in unraveling new pathways underlying such dramatic events. In addition, they will also be used as additional markers to increase the performance of the already existing risk-scoring models for predicting the above-mentioned outcomes in T2DM, as well as for setting up new preventive and treatment strategies, possibly tailored to specific pathogenic backgrounds. Trial registrationClinicalTrials.gov, NCT02311244; URL https://clinicaltrials.gov/ct2/show/NCT02311244?term=SUMMER&rank=5.

Role of Fenugreek in the prevention of type 2 diabetes mellitus in prediabetes.

BackgroundIt is hypothesized that dietary supplementation with Fenugreek modulates glucose homeostasis and potentially prevents diabetes mellitus in people with prediabetes. The objective of present study is to determine whether Fenugreek can prevent the outcome of T2DM in non diabetic people with prediabetes.MethodsA 3-year randomized, controlled, parallel study for efficacy of Fenugreek (n = 66) and matched controls (n = 74) was conducted in men and women aged 30–70 years with criteria of prediabetes. Fenugreek powder, 5 g twice a day before meals, was given to study subjects and progression of type 2 diabetes mellitus (T2DM) was monitored at baseline and every 3 months for the 3-year study.ResultsBy the end of intervention period, cumulative incidence rate of diabetes reduced significantly in Fenugreek group when compared to controls. The Fenugreek group also saw a significant reduction in fasting plasma glucose (FPG), postprandial plasma glucose (PPPG) and low density lipoprotein cholesterol (LDLc) whereas serum insulin increased significantly. It was observed that controls had 4.2 times higher chance of developing diabetes compared to subjects in the Fenugreek group. The outcome of diabetes in Fenugreek group was positively associated with serum insulin and negatively associated with insulin resistance (HOMA IR).ConclusionsDietary supplementation of 10 g Fenugreek/day in prediabetes subjects was associated with lower conversion to diabetes with no adverse effects and beneficial possibly due to its decreased insulin resistance.