Status:
NOT_YET_RECRUITING
The REmission of Diabetes Using a PlAnt-based Weight Loss InteRvention (REPAIR) Trial
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Unity Health Toronto
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
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 ca...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2029
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06906172
Start Date
September 1 2025
End Date
December 30 2029
Last Update
April 2 2025
Active Locations (1)
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1
Unity Health Toronto (St. Michael's Hospital)
Toronto, Ontario, Canada