PREVENT-DM Comparative Effectiveness Trial of Lifestyle Intervention and Metformin

Abstract

Introduction Although the Diabetes Prevention Program and other clinical trials demonstrated the efficacy of intensive lifestyle interventions (ILI) and metformin to prevent Type 2 diabetes, no studies have tested their comparative effects in pragmatic settings. This study was designed to compare the real-world effectiveness of ILI, metformin, and standard care among Hispanic women (Latinas) with prediabetes. Study design RCT. Setting/participants Ninety-two Latinas, who had a mean hemoglobin A1c of 5.9%, BMI of 33.3 kg/m2, and waist circumference of 97.4 cm, were recruited from an urban community and randomly assigned to ILI, metformin, or standard care using 1:1:1 allocation. Data were collected from 2013–2015 and analyzed in 2016. Intervention The 12-month ILI was adapted from the Diabetes Prevention Program’s ILI and delivered by community health workers (promotoras) over 24 sessions. Metformin participants received 850 mg twice daily. Those randomized to standard care continued their regular medical care. Main outcome measures Weight and secondary outcomes (waist circumference, blood pressure, hemoglobin A1c, fasting plasma glucose, insulin, and lipids) were assessed at baseline and 12 months. Results ILI participants demonstrated significantly greater mean weight loss (−4.0 kg, 5.0%) than metformin (−0.9 kg, 1.1%) and standard care participants (+0.8 kg, 0.9%) (p<0.001). The difference in weight loss between metformin and standard care was not significant. The ILI group experienced a greater reduction in waist circumference than standard care (p=0.001), and a marginal improvement in hemoglobin A1c compared with metformin and standard care (p=0.063). Conclusions In the first comparative effectiveness trial of diabetes prevention treatments, a 12-month ILI produced significantly greater weight loss than metformin and standard care among Latinas with prediabetes. These data suggest that ILI delivered by promotoras is an effective strategy for preventing diabetes in this high-risk group, which may be superior to metformin. Future pragmatic trials involving larger samples should examine differences in diabetes incidence associated with these treatments.

Association of changes in mental health with weight loss during intensive lifestyle intervention: does the timing matter?

“…The pragmatic consideration to not exclude participants with clinical levels of depression and anxiety in PREVENT‐DM may better reflect the mental health status of adults participating in community‐based ILI programs. On average, baseline depression and anxiety scores among participants in the current analysis were higher than the general population, but below clinical cutoffs used to define mild depression and anxiety on the same scales . However, the number of participants with baseline depression and anxiety scores above these clinical cutoffs was 35 and 37, respectively (data not shown).…”

“…Participants in the standard care arm had two study visits during the 12-month intervention period when they received written educational materials about preventing type 2 diabetes. In the main effects from this trial, there was a significant difference in 12-month weight loss among ILI participants relative to metformin (À3.1 kg, P = 0.013) and standard care (À4.8 kg, P < 0.001) (17). The weight change observed in the metformin and standard care arms was not significantly different (17).…”

“…In the main effects from this trial, there was a significant difference in 12‐month weight loss among ILI participants relative to metformin (−3.1 kg, P = 0.013) and standard care (−4.8 kg, P < 0.001) . The weight change observed in the metformin and standard care arms was not significantly different . The protocol for this study was approved by the Northwestern University IRB.…”

“…The overall mean BMI was 33.3 kg/m 2 (data not shown) (18). Demographic and other cardiometabolic data have been presented in-depth elsewhere (17,18). In the ILI group, mean baseline scores for the BDI, GAD-7, and PSS were 13.5 ± 9.9, 4.7 ± 4.6, and 23.9 ± 7.7, respectively.…”

Metformin - A Panacea Pharmaceutical Agent through convergence revolution initiative

“…Since metformin is a drug which lowers insulin results in an improved weight loss. Metformin along with a structured lifestyle intervention [21][22][23] improves insulin sensitivity through increasing muscle glucose uptake and use. Obstetrics and gynecological conditions like irregular menstrual cycles and delayed pregnancy has been reversed at the doses of 500 mg to 850 mg of metformin thrice a day.…”