Diabetes MellitusREPAIRNCT06906172
The REmission of Diabetes Using a PlAnt-based Weight Loss InteRvention (REPAIR) Trial
A study testing Plant-based intensive lifestyle intervention in people with Diabetes Mellitus, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Plant-based intensive lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2025to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Unity Health Toronto (St. Michael's Hospital)
Toronto, Ontario
Research Study Coordinator, 416-867-7474, REPAIRtrial@unityhealth.to
About this study
Official title: Effects of Plant-based Dietary Patterns on Diabetes Remission: 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:
Read more
- 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
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
- Being tested
- Plant-based intensive lifestyle intervention, Standard of Care
- Keywords
- diabetes remission, weight loss, plant-based, diet, exercise, intensive lifestyle intervention, behavioural intervention, digital program
- Medical subject headings
- Diabetes Mellitus, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based intensive lifestyle interventionBehavioural
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion achieving diabetes remission
Proportion achieving diabetes remission, defined as an HbA1C <6.5% for ≥3 months free of antihyperglycemic medications at 52 weeks.
Measured: From enrollment to the end of treatment at 52 weeks.
Secondary outcomes (15)
Key secondary: Proportion achieving ≥15% weight loss
Proportion achieving ≥15% weight loss from baseline at 52 weeks.
Measured: From enrollment to the end of treatment at 52 weeks.
Proportion achieving ≥10% and ≥5% weight loss from baseline change
Proportion achieving ≥10% and ≥5% weight loss from baseline at 52 weeks
Measured: From enrollment to the end of treatment at 52 weeks
Changes in measures of body composition
Changes in body weight
Measured: From enrollment to the end of treatment at 52 weeks.
Changes in measures of body composition
Changes in body mass index
Measured: From enrollment to the end of treatment at 52 weeks.
Changes in measures of body composition
Changes in waist circumference
Measured: From enrollment to the end of treatment at 52 weeks.
Changes in measures of body composition
Changes in body fat
Measured: From enrollment to the end of treatment at 52 weeks.
Changes in measures of body composition
Changes in lean body mass
Measured: From enrollment to the end of treatment at 52 weeks.
Proportion experiencing relapse
Proportion experiencing relapse, defined as having achieved remission at any time during the trial but having an HbA1c ≥6.5% at 52 weeks.
Measured: From enrollment to the end of treatment at 52 weeks.
Changes in functional tests
Changes in sit-stand chair
Measured: From enrollment to the end of treatment at 52 weeks.
Changes in functional tests
Changes in grip test
Measured: From enrollment to the end of treatment at 52 weeks.
Changes in glycemic control
Changes in HbA1c
Measured: From enrollment to the end of treatment at 52 weeks.
Changes in glycemic control
Changes in fasting plasma glucose
Measured: From enrollment to the end of treatment at 52 weeks.
Changes in blood lipids
Changes in LDL-cholesterol, non-HDL cholesterol, HDL-cholesterol, total cholesterol and triglycerides.
Measured: From enrollment to the end of treatment at 52 weeks.
Changes in blood pressure
Changes in systolic and diastolic blood pressure.
Measured: From enrollment to the end of treatment at 52 weeks.
Changes in inflammation
Changes in c-reactive protein (CRP)
Measured: From enrollment to the end of treatment at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study startSep 2025 (estimated)
- Primary completion19 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Principal investigator, Laura Chiavaroli, University of Toronto
- Investigators
- Dr. Laura Chiavaroli, MSc, PhD, Principal investigator, University of TorontoDr. John L Sievenpiper, MD, PhD, FRCPC, Principal investigator, University of Toronto, St. Michael's HospitalDr. David JA Jenkins, OC, MD, PhD, DSC, FRCP, FRCPSC, Principal investigator, University of Toronto, St. Michael's HospitalDr. Cyril WC Kendall, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906172
- Sponsor's protocol ID
- REB 24-227
- Acronym
- REPAIR
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All outcomes listed will be shared in an anonymous/de-identified format.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Plant-based Dietary Patterns on Diabetes Remission: the REmission of Diabetes Using a PlAnt-based Weight Loss InteRvention (REPAIR) Trial
- ClinicalTrials.gov ID
- NCT06906172
- Acronym / sponsor ID
- REPAIR / REB 24-227
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes remission, weight loss, plant-based, diet, exercise, intensive lifestyle intervention, behavioural intervention, digital program
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- Sep 2025 (estimated)
- Primary completion
- 19 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plant-based intensive lifestyle intervention | Experimental | Behavioral: Plant-based intensive lifestyle interventionParticipants 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. |
| standard of care | Active comparator | Other: Standard of CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-based intensive lifestyle interventionThe 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. | Behavioural | plant-based intensive lifestyle intervention |
| Standard of CareParticipants 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. | Other | standard of care |
Primary outcome
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.
15 secondary outcomes
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.
Changes in blood lipids
Time frame: From enrollment to the end of treatment at 52 weeks.
Changes in blood pressure
Time frame: From enrollment to the end of treatment at 52 weeks.
Changes in inflammation
Time frame: From enrollment to the end of treatment at 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Yes. All outcomes listed will be shared in an anonymous/de-identified format.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Laura Chiavaroli, MSc, PhD principal investigator
University of Toronto
Dr. John L Sievenpiper, MD, PhD, FRCPC principal investigator
University of Toronto, St. Michael's Hospital
Dr. David JA Jenkins, OC, MD, PhD, DSC, FRCP, FRCPSC principal investigator
University of Toronto, St. Michael's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based intensive lifestyle intervention in people with Diabetes Mellitus, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Study Coordinator (416-867-7474, REPAIRtrial@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion achieving diabetes remission (time frame: From enrollment to the end of treatment at 52 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.