Abstract
Background: The Republic of the Marshall Islands (RMI) has the highest rate of type 2 diabetes (T2D) in the world. Lifestyle interventions, including plant-based diets and exercise, have been shown to effectively manage T2D. Objective: We therefore conducted the largest plant-based lifestyle intervention in adults with T2D. The goal of this study was to determine whether a plant-based lifestyle intervention is more effective than the standard of care for treating type 2 diabetes. Methods: We conducted a parallel-arm randomized clinical trial in Majuro, RMI. Adults with T2D were randomized to either standard of diabetes care (SOC) or a plant-based lifestyle intervention (PB+Ex) for 24 weeks. The first 12 weeks of the intervention involved the provision of plant-rich meals, counselling, cooking classes, and group exercise sessions, which gradually decreased in frequency over the 12-week period. Thereafter, from Weeks 13-24, participants in the PB+Ex group were instructed to continue the lifestyle intervention on their own. The primary outcome was change in HbA1c. Secondary outcomes included fasting glucose, insulin, blood pressure, lipids, and medication use. Outcome data was collected at five time points and analyzed using linear mixed models. Results: One hundred thirty-eight adults with T2D started the intervention (mean ± SD; age: 54.3 ± 8.6 years, HbA1c: 10.3 ± 2.1%; 50.7% female) . PB+Ex reduced HbA1c by 1.3 ± 0.3% (lsmean ± SEM; p<0.001) and 0.7 ± 0.3% (p=0.01) at weeks 12 and 24, respectively, compared to SOC. PB+Ex also decreased BMI at weeks 12 and 24 (both -1.1 kg/m2; p<0.001) . Additionally, PB+Ex reduced C-reactive protein and waist circumference compared to SOC. Additional analyses on other fasting cardiometabolic endpoints and medication changes are underway. Conclusions: A plant-based intensive lifestyle intervention with exercise is more effective at improving glycemic control, BMI, and inflammatory markers than the standard of diabetes care. Disclosure C.Hanick: None. C.M.Peterson: None. J.Sabaté: None. B.C.Davis: None. J.W.Spence: None. J.Kelly: None. Funding Department of the Army (W81XWH-05-1-0547)
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