Rationale and design of a parallel randomised trial of a plant-based intensive lifestyle intervention for diabetes remission: The REmission of diabetes using a PlAnt-based weight loss InteRvention (REPAIR) trial

Identifier:  imarina:9514372

Handle: https://hdl.handle.net/20.500.11797/imarina9514372

Authors:  McKay, Brighid; El Chaar, Dayana; Paquette, Melanie; Vallis, Michael; Sherifali, Diana; Oh, Paul; Marzolini, Susan; Dasgupta, Kaberi; Booth, Gillian; Lean, Mike; Gerstein, Hertzel C; Salas-salvado, Jordi; Beaudry, Jacqueline L; Marinangeli, Christopher P F; de Souza, Russell J; Leiter, Lawrence A; Kendall, Cyril W C; Jenkins, David J A; Sievenpiper, John L; Chiavaroli, Laura

Abstract:
Aims As type 2 diabetes (T2D) continues to rise globally and remains a major driver of cardiovascular disease, its remission has emerged as a therapeutic target. Current evidence supports bariatric surgery and low-calorie diets with meal replacements. No clinical trial to date has evaluated plant-based dietary alternatives as an intensive lifestyle intervention (ILI) strategy, despite the emphasis on plant-based diets in current clinical practice guidelines for diabetes and cardiovascular disease. The REmission of diabetes using a PlAnt-based weight loss InteRvention (REPAIR) trial will assess whether a 52-week plant-based ILI targeting >= 15% weight loss is effective for diabetes remission in a multi-ethnic Canadian population.Materials and Methods The REPAIR trial is a prospective, randomised, 2-arm, open-label, blinded-endpoint efficacy trial. Participants will include 160 adults with early T2D (= 15% weight loss consisting of a 12-week weight loss phase on a plant-based total diet meal replacement, followed by a 40-week weight loss maintenance phase on a plant-based dietary pattern combined with a 16-week structured exercise program, and a 52-week (19-session) sustainable behaviour change curriculum. The primary outcome is diabetes remission (HbA1c = 3 months) and the key secondary outcome is the proportion achieving >= 15% weight loss at 52 weeks.Conclusions This trial will provide high-quality clinical evidence on the use of plant-based ILIs to address the epidemics of obesity and diabetes to inform public health policies and programs in Canada and beyond.