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NCT Number: NCT06906172

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

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

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Key information

Conditions

Diabetes Mellitus Behavior Body Weight Body Weight Changes Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unity Health Toronto (St. Michael's Hospital)

Toronto, Ontario, Canada

Location contact

Research Study Coordinator

CONTACT

[email protected]

416-867-7474

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Proportion achieving diabetes remission

    Time frame: From enrollment to the end of treatment at 52 weeks.

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

Secondary outcomes

  1. Key secondary: Proportion achieving ≥15% weight loss

    Time frame: From enrollment to the end of treatment at 52 weeks.

    Proportion achieving ≥15% weight loss from baseline at 52 weeks.

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

    Time frame: From enrollment to the end of treatment at 52 weeks

    Proportion achieving ≥10% and ≥5% weight loss from baseline at 52 weeks

  3. Changes in measures of body composition

    Time frame: From enrollment to the end of treatment at 52 weeks.

    Changes in body weight

  4. Changes in measures of body composition

    Time frame: From enrollment to the end of treatment at 52 weeks.

    Changes in body mass index

  5. Changes in measures of body composition

    Time frame: From enrollment to the end of treatment at 52 weeks.

    Changes in waist circumference

  6. Changes in measures of body composition

    Time frame: From enrollment to the end of treatment at 52 weeks.

    Changes in body fat

  7. Changes in measures of body composition

    Time frame: From enrollment to the end of treatment at 52 weeks.

    Changes in lean body mass

  8. Proportion experiencing relapse

    Time frame: From enrollment to the end of treatment at 52 weeks.

    Proportion experiencing relapse, defined as having achieved remission at any time during the trial but having an HbA1c ≥6.5% at 52 weeks.

  9. Changes in functional tests

    Time frame: From enrollment to the end of treatment at 52 weeks.

    Changes in sit-stand chair

  10. Changes in functional tests

    Time frame: From enrollment to the end of treatment at 52 weeks.

    Changes in grip test

  11. Changes in glycemic control

    Time frame: From enrollment to the end of treatment at 52 weeks.

    Changes in HbA1c

  12. Changes in glycemic control

    Time frame: From enrollment to the end of treatment at 52 weeks.

    Changes in fasting plasma glucose

  13. Changes in blood lipids

    Time frame: From enrollment to the end of treatment at 52 weeks.

    Changes in LDL-cholesterol, non-HDL cholesterol, HDL-cholesterol, total cholesterol and triglycerides.

  14. Changes in blood pressure

    Time frame: From enrollment to the end of treatment at 52 weeks.

    Changes in systolic and diastolic blood pressure.

  15. Changes in inflammation

    Time frame: From enrollment to the end of treatment at 52 weeks

    Changes in c-reactive protein (CRP)

Study contacts

Contact information is provided by the study sponsor or research team.

Research Study Coordinator

CONTACT

[email protected]

416-867-7474

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Unity Health Toronto

Registry information

Official study title

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

Acronym: REPAIR

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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