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

Official title

Effects of Plant-based Dietary Patterns on Diabetes Remission: the REmission of Diabetes Using a PlAnt-based Weight Loss InteRvention (REPAIR) Trial

Overview

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

Interventions

• Behavioral 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, progre
• Other 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 c

Primary outcome measures

• Proportion achieving diabetes remission [Time frame: From enrollment to the end of treatment at 52 weeks.]

Secondary outcome measures (12)

• Key secondary: Proportion achieving ≥15% weight loss [Time frame: From enrollment to the end of treatment at 52 weeks.]
• Proportion achieving ≥10% and ≥5% weight loss from baseline change [Time frame: From enrollment to the end of treatment at 52 weeks]
• Changes in measures of body composition [Time frame: From enrollment to the end of treatment at 52 weeks.]
• Changes in measures of body composition [Time frame: From enrollment to the end of treatment at 52 weeks.]
• Changes in measures of body composition [Time frame: From enrollment to the end of treatment at 52 weeks.]
• Changes in measures of body composition [Time frame: From enrollment to the end of treatment at 52 weeks.]
• Changes in measures of body composition [Time frame: From enrollment to the end of treatment at 52 weeks.]
• Proportion experiencing relapse [Time frame: From enrollment to the end of treatment at 52 weeks.]
• Changes in functional tests [Time frame: From enrollment to the end of treatment at 52 weeks.]
• Changes in functional tests [Time frame: From enrollment to the end of treatment at 52 weeks.]
• Changes in glycemic control [Time frame: From enrollment to the end of treatment at 52 weeks.]
• Changes in glycemic control [Time frame: From enrollment to the end of treatment at 52 weeks.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Unity Health Toronto (St. Michael's Hospital) — Toronto

Identifiers

NCT: NCT06906172 · REB 24-227

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗