Plant-based Lifestyle Intervention for Diabetes

(REPAIR Trial)

Overseen By Research Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Must be taking: Non-insulin antihyperglycemics

Must not be taking: Insulin, GLP-1/GIP agonists, Anti-obesity drugs

Disqualifiers: Type 1 diabetes, Recent weight loss, Eating disorder, Allergies, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a plant-based diet and lifestyle can help individuals with type 2 diabetes lower blood sugar and lose significant weight without medication. Participants will either continue their usual diabetes care or follow a structured plant-based diet and exercise plan, known as a plant-based intensive lifestyle intervention. The trial seeks individuals diagnosed with type 2 diabetes within the last six years, who are not using insulin, and are managing their condition with certain medications. As an unphased trial, this study offers a unique opportunity to explore innovative lifestyle changes that could improve health and well-being.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, participants in the standard care group will continue their usual diabetes care, which suggests they may stay on their current medications.

What prior data suggests that this plant-based lifestyle intervention is safe for diabetes patients?

Research has shown that plant-based diets can be safe and beneficial for people with diabetes. One study found that following a whole-food, plant-based diet improved blood sugar control. Another study demonstrated that this diet can safely reduce the need for diabetes medication while effectively managing the condition.

Plant-based diets are linked to a lower risk of developing type 2 diabetes, indicating they are generally safe and can help control blood sugar levels. These diets emphasize fruits, vegetables, and whole grains, which are nutritious and typically easy to digest. Participants in previous studies experienced improvements without major side effects, suggesting the diet is safe for those with diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for diabetes, which often involves medications like metformin or insulin, the plant-based intensive lifestyle intervention is unique because it focuses entirely on dietary and lifestyle changes without the use of antihyperglycemic drugs. This approach aims to achieve diabetes remission through weight loss and a plant-based diet, potentially reducing or eliminating the need for medication altogether. Researchers are excited about this method because it could offer a natural, sustainable way to manage diabetes, promoting overall health and reducing long-term dependency on medications.

What evidence suggests that this plant-based lifestyle intervention might be an effective treatment for diabetes?

Research has shown that a plant-based lifestyle change can help manage and even reverse type 2 diabetes. In this trial, participants in the plant-based intensive lifestyle intervention arm will follow a program targeting weight loss to achieve diabetes remission. Studies have found that these diets improve blood sugar control and reduce the need for diabetes medications. For instance, one study found that 8% of all participants, and 23% of those with lower starting blood sugar levels, reversed their diabetes. Another study showed that 46% of participants reversed their diabetes after losing an average of 10 kg (about 22 pounds) over a year. Plant-based diets are also linked to significant weight loss, aiding in diabetes management. ^{1 3 4 5 6}

Who Is on the Research Team?

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

Dr. Cyril WC Kendall, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for individuals with diabetes who are looking to achieve remission and significant weight loss. Participants should be willing to follow a plant-based diet and exercise program or continue their usual care, attend multiple clinic visits, allow measurements like weight and blood pressure to be taken, provide blood samples, track food intake and exercise, and complete questionnaires.

Inclusion Criteria

Obese (body mass index [BMI] and waist circumference using sex and ethnic-specific thresholds for obesity and significant abdominal adiposity)

Have an HbA1c 6.0-10.0%

Have a family physician and an Ontario Health Card

Exclusion Criteria

Told by a doctor to refrain from physical activity

I have kidney problems.

Allergy or intolerance to soy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow either a plant-based intensive lifestyle intervention or continue with standard diabetes care

52 weeks

5 visits (standard care), every 2-4 weeks (plant-based intervention)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Plant-based intensive lifestyle intervention

Trial Overview

The REPAIR Trial is testing whether a plant-based intensive lifestyle intervention can help people with diabetes reach remission without medication and lose at least 15% of their initial body weight. It compares this approach against the standard diabetes care over a period of 12 months.

How Is the Trial Designed?

Group I: plant-based intensive lifestyle intervention Experimental Treatment 1 Intervention

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.

Group II: standard of care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Published Research Related to This Trial

In a pilot program involving 17 participants, the adoption of a Whole Food Plant-based (WFPB) diet resulted in significant weight loss (4.3 kg) and improvements in cholesterol levels, including a decrease in total cholesterol and triglycerides, and an increase in HDL (good cholesterol).

The program, which included educational sessions led by a gastroenterologist, demonstrated the potential effectiveness of WFPB diets in a clinical setting, particularly for patients with conditions like hyperlipidemia and hypertension, suggesting a need for larger-scale studies to further validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Whole Food Plant Based Diet in a Food as Prevention Program in a Resource Constrained Environment. Ganguli, SC., Russell, LA., Tsoi, KS.[2023]

Plant-based diets (PBDs) are associated with a lower prevalence of type 2 diabetes and have been shown to be as effective, if not more effective, than other diabetes diets in improving various health markers such as body weight, insulin sensitivity, and glycated hemoglobin levels.

Patient acceptability of PBDs is comparable to other diabetes diets, and they can reduce the need for diabetes medications, suggesting that PBDs could be a beneficial dietary approach in managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Review of the Literature Supporting Recommendations From the Canadian Diabetes Association for the Use of a Plant-Based Diet for Management of Type 2 Diabetes. Rinaldi, S., Campbell, EE., Fournier, J., et al.[2017]

A plant-based eating pattern, which includes whole grains, vegetables, fruits, and legumes while excluding animal products, is linked to a lower risk of developing type 2 diabetes and is effective in managing the condition.

This diet improves key health markers such as blood glucose levels, body weight, and blood pressure, and it also enhances insulin sensitivity and β-cell function, which are crucial for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: Plant-Based Eating Pattern for Type 2 Diabetes Prevention and Treatment: Efficacy, Mechanisms, and Practical Considerations. Jardine, MA., Kahleova, H., Levin, SM., et al.[2023]

Plant-based nutrition education is an effective intervention for managing type 2 diabetes, helping to improve glycemic control and reduce body weight.

A low-fat, plant-based diet is not only well-accepted by patients but also beneficial for reducing cardiac risk, making it a comprehensive approach for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A plant-based diet for type 2 diabetes: scientific support and practical strategies. Trapp, C., Barnard, N., Katcher, H.[2020]

Plant-based diets may help delay the progression of diabetic kidney disease (DKD) by focusing on whole foods and reducing processed foods and advanced glycation end products (AGE).

Current evidence is limited and mostly from smaller studies, highlighting the need for larger trials to better understand the impact of plant-based diets on kidney function and overall health outcomes in DKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and Diabetic Kidney Disease: Plant Versus Animal Protein. Moorthi, RN., Vorland, CJ., Hill Gallant, KM.[2022]

Only 9% of patients with type 2 diabetes currently follow a plant-based diet, but 66% expressed willingness to try it for 3 weeks, indicating a potential for increased adoption with proper education.

While 72% of healthcare providers are aware of the benefits of plant-based diets for diabetes management, their low levels of practice suggest a need for educational interventions to improve both patient and provider knowledge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness and perception of plant-based diets for the treatment and management of type 2 diabetes in a community education clinic: a pilot study. Lee, V., McKay, T., Ardern, CI.[2020]

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The goal of this clinical trial is to learn if a plant-based intensive lifestyle intervention can achieve remission of diabetes.