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

NCT ID: NCT06906172

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2029-12-30

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

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

plant-based intensive lifestyle intervention

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.

Group Type: EXPERIMENTAL

Plant-based intensive lifestyle intervention

Intervention Type: BEHAVIORAL

The plant-based intensive lifestyle intervention has 2 phases. The first 12-weeks is a weight loss phase consisting of a plant-based, high-plant protein energy restricted total diet replacement (TDR), psyllium-based fibre and complete multivitamin supplements, and vegetable bouillon, with the option of continuing with this phase up to week 20. The second phase is weight-loss maintenance beginning with an 8-week (weeks 12-20) stepped food reintroduction phase with partial meal replacement, progressing towards the 32-week (weeks 20-52) full food introduction phase. These phases focus on introducing a plant-based, high-plant protein, energy balanced, weight loss maintenance diet, which will be supported by a digital program. At weeks 12-28, a 16-week in-person structured exercise training program will be delivered followed by 2-weekly motivational phone calls until the 52-weeks. A 19-session, group-based, structured behavioural support program will be delivered throughout the study.

standard of care

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Participants will continue to receive usual diabetes and obesity management as per current Canadian clinical practice guidelines. The management will continue to be delivered to participants through their family doctor, nurse practitioner, or diabetes care team with standard frequency of contact. Participants will attend clinic visits on 5 occasions (weeks 0, 12, 28, 40 and 52) and will receive motivational phone calls between visits to provide reminders regarding follow-up with their diabetes care providers.

Interventions

Plant-based intensive lifestyle intervention

The plant-based intensive lifestyle intervention has 2 phases. The first 12-weeks is a weight loss phase consisting of a plant-based, high-plant protein energy restricted total diet replacement (TDR), psyllium-based fibre and complete multivitamin supplements, and vegetable bouillon, with the option of continuing with this phase up to week 20. The second phase is weight-loss maintenance beginning with an 8-week (weeks 12-20) stepped food reintroduction phase with partial meal replacement, progressing towards the 32-week (weeks 20-52) full food introduction phase. These phases focus on introducing a plant-based, high-plant protein, energy balanced, weight loss maintenance diet, which will be supported by a digital program. At weeks 12-28, a 16-week in-person structured exercise training program will be delivered followed by 2-weekly motivational phone calls until the 52-weeks. A 19-session, group-based, structured behavioural support program will be delivered throughout the study.

Intervention Type: BEHAVIORAL

Standard of Care

Participants will continue to receive usual diabetes and obesity management as per current Canadian clinical practice guidelines. The management will continue to be delivered to participants through their family doctor, nurse practitioner, or diabetes care team with standard frequency of contact. Participants will attend clinic visits on 5 occasions (weeks 0, 12, 28, 40 and 52) and will receive motivational phone calls between visits to provide reminders regarding follow-up with their diabetes care providers.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Laura Chiavaroli

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Laura Chiavaroli, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Dr. John L Sievenpiper, MD, PhD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Toronto, St. Michael's Hospital

Dr. David JA Jenkins, OC, MD, PhD, DSC, FRCP, FRCPSC

Role: PRINCIPAL_INVESTIGATOR

University of Toronto, St. Michael's Hospital

Dr. Cyril WC Kendall, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Unity Health Toronto (St. Michael's Hospital)

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Research Study Coordinator

Role: CONTACT

REPAIRtrial@unityhealth.to

416-867-7474

Facility Contacts

Research Study Coordinator

Role: primary

REPAIRtrial@unityhealth.to

416-867-7474

Other Identifiers

REB 24-227

Identifier Type: -

Identifier Source: org_study_id