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NCT06906172 | NOT YET RECRUITING | Diabetes Mellitus

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

University of Toronto

Information provided by (Responsible Party):

Laura Chiavaroli

Brief 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

Condition or disease

Diabetes Mellitus

Intervention/treatment

Plant-based intensive lifestyle intervention

Standard of Care

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : NONE
Masking Description : The statistician will be masked to the treatments.
Primary Purpose : TREATMENT
Official Title : Effects of Plant-based Dietary Patterns on Diabetes Remission: the REmission of Diabetes Using a PlAnt-based Weight Loss InteRvention (REPAIR) Trial
Actual Study Start Date : 2025-09
Estimated Primary Completion Date : 2028-12-19
Estimated Study Completion Date : 2029-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age of 18 years;
  • * Equal number of males and females;
  • * Obese (body mass index \[BMI\] and waist circumference using sex and ethnic-specific thresholds for obesity and significant abdominal adiposity);
  • * Diagnosed with type 2 diabetes within the last 6 years;
  • * Treated by non-insulin antihyperglycemic therapy;
  • * Have an HbA1c 6.0-10.0%;
  • * Taking a stable dose of antihypertensive, antihyperglycemic, or antihyperlipidemic medications for ≥3-months, if applicable;
  • * Have a family physician and an Ontario Health Card;
Exclusion Criteria
  • * Type 1 diabetes;
  • * HbA1c \<6.0% or \>10%;
  • * Recent weight loss (≥5 kg) in the last 6 months;
  • * Treated with diet alone;
  • * Treated with insulin;
  • * Treated with GLP-1/GIP/glucagon receptor agonist therapies;
  • * Treated with other anti-obesity drugs;
  • * Eating disorder, substance abuse disorder, serious depression, psychiatric disorder;
  • * Allergy or intolerance to soy;
  • * Allergy or intolerance to peanuts, tree nuts and seeds (all three);
  • * Pregnant or intending pregnancy;
  • * Currently breastfeeding;
  • * Bariatric or surgery in the last 6 months;
  • * Major cardiovascular event in the last 6 months;
  • * Kidney dysfunction;
  • * Unstable or severe heart failure;
  • * Major illness or chronic infection;
  • * Atherosclerotic cardiovascular disease (ASCVD);
  • * Chronic kidney disease (CKD);
  • * Treated for cancer in the last 12 months;
  • * Participating in another trial;
  • * Told by a doctor to refrain from physical activity;
  • * Any condition that would prevent you from following study procedures;
  • * Family physician does not consent to your participation
The REmission of Diabetes Using a PlAnt-based Weight Loss InteRvention (REPAIR) Trial

Location Details

NCT06906172

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Canada, Ontario

Unity Health Toronto (St. Michael's Hospital)

Toronto, Ontario, Canada,