Clinical Trial

The REmission of Diabetes Using a PlAnt-based Weight Loss InteRvention (REPAIR) Trial

Study acronym: REPAIR
Not Yet Recruiting
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Summary
The goal of this clinical trial is to learn if a plant-based intensive lifestyle intervention can achieve remission of diabetes. It will also learn if a plant-based intensive lifestyle intervention can achieve weight loss ≥15% of initial body weight. The main questions it aims to answer are: * What proportion of participants achieved diabetes remission (normal blood sugar for at least 3 months without medication)? * What proportion of participants achieved ≥15% weight loss from their initial weight? * What is the impact on weight, body composition, blood pressure, blood sugars, cholesterol and inflammation levels? Researchers will compare the plant-based intensive lifestyle intervention to the current standard of care. Participants will be randomly placed into one of two groups: 1. Standard of care, where they will continue their usual diabetes care with their health care providers 2. Plant-based intensive lifestyle intervention, where they will follow a diet and exercise program Participants in the standard of care will: * Continue with their usual diabetes care for 12 months * Attend clinic visits on 5 occasions over the 12 months * Allow study staff to take measurements (e.g. weight, blood pressure) * Provide blood samples * Track their food and exercise and complete questionnaires Participants in the plant-based intensive lifestyle intervention will: * Follow a plant-based low calorie diet for 3 months followed by a calorie-balanced plant-based diet for 9 months * Participate in a 16-week exercise program * Attend clinic visits every 2-4 weeks over the 12 months * Allow study staff to take measurements (e.g. weight, blood pressure) * Provide blood sample * Track their food and exercise and complete questionnaires
Trial Details
NCT Number NCT06906172
Lead Sponsor University of Toronto
Collaborators: Unity Health Toronto
Conditions Diabetes Mellitus
Enrollment 160 participants
Start Date 2025-09
Primary Completion 2028-12-19 (estimated)
Study Completion 2029-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-04-02