Statin use and risk of developing diabetes: results from the Diabetes Prevention Program

Objective Several clinical trials of cardiovascular disease prevention with statins have reported increased risk of type 2 diabetes (T2DM) with statin therapy. However, participants in these studies were at relatively low risk for diabetes. Further, diabetes was often based on self-report and was not the primary outcome. It is unknown whether statins similarly modify diabetes risk in higher risk populations. Research design and methods During the Diabetes Prevention Program Outcomes Study (n=3234), the long-term follow-up to a randomized clinical trial of interventions to prevent T2DM, incident diabetes was assessed by annual 75 g oral glucose tolerance testing and semiannual fasting glucose. Lipid profile was measured annually, with statin treatment determined by a participant’s own physician outside of the protocol. Statin use was assessed at baseline and semiannual visits. Results At 10 years, the cumulative incidence of statin initiation prior to diabetes diagnosis was 33%–37% among the randomized treatment groups (p=0.36). Statin use was associated with greater diabetes risk irrespective of treatment group, with pooled HR (95% CI) for incident diabetes of 1.36 (1.17 to 1.58). This risk was not materially altered by adjustment for baseline diabetes risk factors and potential confounders related to indications for statin therapy. Conclusions In this population at high risk for diabetes, we observed significantly higher rates of diabetes with statin therapy in all three treatment groups. Confounding by indication for statin use does not appear to explain this relationship. The effect of statins to increase diabetes risk appears to extend to populations at high risk for diabetes. Trial registration number NCT00038727; Results

Deconstructing Weight Management Interventions for Young Adults: Looking Inside the Black Box of the EARLY Consortium Trials.

ObjectiveThe goal of the present study was to deconstruct the 17 treatment arms used in the Early Adult Reduction of weight through LifestYle (EARLY) weight management trials.MethodsIntervention materials were coded to reflect behavioral domains and behavior change techniques (BCTs) within those domains planned for each treatment arm. The analytical hierarchy process was employed to determine an emphasis profile of domains in each intervention.ResultsThe intervention arms used BCTs from all of the 16 domains, with an average of 29.3 BCTs per intervention arm. All 12 of the interventions included BCTs from the six domains of Goals and Planning, Feedback and Monitoring, Social Support, Shaping Knowledge, Natural Consequences, and Comparison of Outcomes; 11 of the 12 interventions shared 15 BCTs in common across those six domains.ConclusionsWeight management interventions are complex. The shared set of BCTs used in the EARLY trials may represent a core intervention that could be studied to determine the required emphases of BCTs and whether additional BCTs add to or detract from efficacy. Deconstructing interventions will aid in reproducibility and understanding of active ingredients

Beneficial effects of replacing diet beverages with water on type 2 diabetic obese women following a hypo-energetic diet: a randomized, 24-week clinical trial

Abstract AIMS: To compare the effect of replacing diet beverages (DBs) with water or continuing to drink DBs in patients with type 2 diabetes during a 24-week weight loss program. The primary endpoint was the effect of intervention on weight over a 24-week period. The main secondary endpoints included anthropometric measurement and glucose and fat metabolism during the 24-week period. METHODS: A total of 81 overweight and obese women with type 2 diabetes, who usually consumed DBs in their diet, were asked to either substitute water for DBs or continue drinking DBs five times per week after lunch for 24 weeks (DBs group) during a weight loss program. RESULTS: Compared with the DBs group, the water group had a greater decrease in weight (water, -6.40 ± 2.42 kg; DBs, -5.25 ± 1.60 kg; P = .006), in BMI (water, -2.49 ± 0.92 kg/m2 ; DBs, -2.06 ± 0.62 kg/m2 ; P = .006), in FPG (water, -1.63 ± 0.54 mmol/L; DBs, -1.29 ± 0.48 mmol/L, P = .005), in fasting insulin (water, -5.71 ± 2.30 m lU/mL; DBs, -4.16 ± 1.74 m lU/mL, P = .011), in HOMA IR (water, -3.20 ± 1.17; DBs, -2.48 ± 0.99, P = 003) and in 2 hour postprandial glucose (water, -1.67 ± 0.62 mmol/L; DBs, -1.35 ± 0.39 mmol/L; P = 0.027) over the 24-week period. However, there was no significant time × group interaction for waist circumference, lipid profiles and HbA1c within both groups over the 24-week period. CONCLUSION: Replacement of DBs with water after the main meal in obese adult women with type 2 diabetes may lead to more weight reduction during a weight loss program