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

NCT06906172 | Not Yet Recruiting

• 1 other identifier: REB 24-227
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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:
• Standard of care, where they will continue their usual diabetes care with their health care providers
• Plant-based intensive lifestyle intervention, where they will follow a diet and exercise program
• 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

Keywords

diabetes remission; weight loss; plant-based; diet; exercise; intensive lifestyle intervention; behavioural intervention; digital program

Outcome Measures

Primary Outcomes (1)

• Proportion achieving diabetes remission

  Proportion achieving diabetes remission, defined as an HbA1C \<6.5% for ≥3 months free of antihyperglycemic medications at 52 weeks.

  From enrollment to the end of treatment at 52 weeks.

Secondary Outcomes (15)

• Key secondary: Proportion achieving ≥15% weight loss

  From enrollment to the end of treatment at 52 weeks.

• Proportion achieving ≥10% and ≥5% weight loss from baseline change

  From enrollment to the end of treatment at 52 weeks

• Changes in measures of body composition

  From enrollment to the end of treatment at 52 weeks.

• Changes in measures of body composition

  From enrollment to the end of treatment at 52 weeks.

• Changes in measures of body composition

  From enrollment to the end of treatment at 52 weeks.

Study Arms (2)

plant-based intensive lifestyle intervention

EXPERIMENTAL

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.

Behavioral: Plant-based intensive lifestyle intervention

standard of care

ACTIVE COMPARATOR

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.

Other: Standard of Care

Interventions

Plant-based intensive lifestyle intervention 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.

plant-based intensive lifestyle intervention

Standard of Care 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.

standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Toronto: lead
• Unity Health Toronto: collaborator

Study Sites (1)

Unity Health Toronto (St. Michael's Hospital)

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Weight Loss; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Dr. Laura Chiavaroli, MSc, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Dr. John L Sievenpiper, MD, PhD, FRCPC

  University of Toronto, St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

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

  University of Toronto, St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

• Dr. Cyril WC Kendall, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Study Coordinator

CONTACT

416-867-7474; REPAIRtrial@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statistician will be masked to the treatments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 2, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 19, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and supporting information will be available after the anticipated study completion date from January 2030 and will remain for 30 years until January 2060.
• Access Criteria: IPD data will be accessible though the University of Toronto Dataverse (https://borealisdata.ca/dataverse/toronto). The metadata record of our dataset will be public, however access to the data will be restricted. Users will need to request access using the contact information provided in order to view and download our restricted files.

Locations

CA (1)