Clinical trial NCT06906172: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes remission
weight loss
plant-based
diet
exercise
intensive lifestyle intervention
behavioural intervention
digital program
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2025-04-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Proportion achieving diabetes remission
timeFrame: From enrollment to the end of treatment at 52 weeks.
Secondary outcomes:
measure: Key secondary: Proportion achieving ≥15% weight loss
timeFrame: From enrollment to the end of treatment at 52 weeks.
measure: Proportion achieving ≥10% and ≥5% weight loss from baseline change
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Changes in measures of body composition
timeFrame: From enrollment to the end of treatment at 52 weeks.
measure: Changes in measures of body composition
timeFrame: From enrollment to the end of treatment at 52 weeks.
measure: Changes in measures of body composition
timeFrame: From enrollment to the end of treatment at 52 weeks.
measure: Changes in measures of body composition
timeFrame: From enrollment to the end of treatment at 52 weeks.
measure: Changes in measures of body composition
timeFrame: From enrollment to the end of treatment at 52 weeks.
measure: Proportion experiencing relapse
timeFrame: From enrollment to the end of treatment at 52 weeks.
measure: Changes in functional tests
timeFrame: From enrollment to the end of treatment at 52 weeks.
measure: Changes in functional tests
timeFrame: From enrollment to the end of treatment at 52 weeks.
measure: Changes in glycemic control
timeFrame: From enrollment to the end of treatment at 52 weeks.
measure: Changes in glycemic control
timeFrame: From enrollment to the end of treatment at 52 weeks.
measure: Changes in blood lipids
timeFrame: From enrollment to the end of treatment at 52 weeks.
measure: Changes in blood pressure
timeFrame: From enrollment to the end of treatment at 52 weeks.
measure: Changes in inflammation
timeFrame: From enrollment to the end of treatment at 52 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Unity Health Toronto (St. Michael's Hospital)
state: Ontario
Study officials:
affiliation: University of Toronto
name: Dr. Laura Chiavaroli, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto, St. Michael's Hospital
name: Dr. John L Sievenpiper, MD, PhD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto, St. Michael's Hospital
name: Dr. David JA Jenkins, OC, MD, PhD, DSC, FRCP, FRCPSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Dr. Cyril WC Kendall, PhD
role: PRINCIPAL_INVESTIGATOR
References: