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

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus

• Registration Number: NCT06906172
• Lead Sponsor: University of Toronto

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Study Start: 2025-09
• Primary Completion: 2028-12-19
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion achieving diabetes remission	From enrollment to the end of treatment at 52 weeks.	Proportion achieving diabetes remission, defined as an HbA1C \<6.5% for ≥3 months free of antihyperglycemic medications at 52 weeks.

Secondary Outcome Measures

Name	Time	Method
Key secondary: Proportion achieving ≥15% weight loss	From enrollment to the end of treatment at 52 weeks.	Proportion achieving ≥15% weight loss from baseline at 52 weeks.
Proportion achieving ≥10% and ≥5% weight loss from baseline change	From enrollment to the end of treatment at 52 weeks	Proportion achieving ≥10% and ≥5% weight loss from baseline at 52 weeks
Changes in measures of body composition	From enrollment to the end of treatment at 52 weeks.	Changes in lean body mass
Proportion experiencing relapse	From enrollment to the end of treatment at 52 weeks.	Proportion experiencing relapse, defined as having achieved remission at any time during the trial but having an HbA1c ≥6.5% at 52 weeks.
Changes in functional tests	From enrollment to the end of treatment at 52 weeks.	Changes in grip test
Changes in glycemic control	From enrollment to the end of treatment at 52 weeks.	Changes in fasting plasma glucose
Changes in blood lipids	From enrollment to the end of treatment at 52 weeks.	Changes in LDL-cholesterol, non-HDL cholesterol, HDL-cholesterol, total cholesterol and triglycerides.
Changes in blood pressure	From enrollment to the end of treatment at 52 weeks.	Changes in systolic and diastolic blood pressure.
Changes in inflammation	From enrollment to the end of treatment at 52 weeks	Changes in c-reactive protein (CRP)

Trial Locations

Locations (1)

Unity Health Toronto (St. Michael's Hospital); 🇨🇦 Toronto, Ontario, Canada