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

University of Toronto

Status: Not yet enrolling

Conditions: Diabetes Mellitus

Treatments: Other: Standard of Care; Behavioral: Plant-based intensive lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06906172

REB 24-227

Details and patient eligibility

About

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

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

plant-based intensive lifestyle intervention

Experimental group

Description:

Participants will undergo a plant-based intensive lifestyle intervention targeting weight loss with the goal of achieving diabetes remission. All antihyperglycemic and/or antihypertensive medications will be stopped at the first visit as a safety measure. The interventions will be delivered at clinic visits at 2-4week intervals over the 52-weeks.

Treatment:

Behavioral: Plant-based intensive lifestyle intervention

standard of care

Active Comparator group

Description:

Participants will continue to receive usual diabetes and obesity management with their health care provider(s) as per current Canadian clinical practice guidelines. Participants will attend clinic visits on 5 occasions over the 52-weeks.

Treatment:

Other: Standard of Care