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

160 Participants Needed

Trial Summary

What is the purpose of this 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

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 data supports the effectiveness of the plant-based lifestyle intervention treatment for diabetes?

Research shows that plant-based diets can significantly improve emotional and physical well-being, quality of life, blood sugar control, weight, and cholesterol levels in people with diabetes, making it an effective treatment option. ^{1 2 3 4 5}

Is a plant-based lifestyle intervention safe for humans?

Research shows that plant-based diets are generally safe for humans and can improve health markers like cholesterol levels and weight. They are recommended for managing type 2 diabetes and have been associated with better emotional and physical well-being. ^{1 4 6 7 8}

How does a plant-based lifestyle intervention differ from other treatments for diabetes?

A plant-based lifestyle intervention for diabetes is unique because it focuses on improving overall well-being and managing blood sugar levels through diet, rather than relying on medication. This approach can lead to better emotional and physical health, weight management, and improved cholesterol levels, offering a holistic alternative to traditional diabetes treatments. ^{1 2 4 5 6}

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

Eligibility Criteria

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.

I have been treated with weight loss medications.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A plant-based diet for type 2 diabetes: scientific support and practical strategies. [2020]

2. United States 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Perspective: Plant-Based Eating Pattern for Type 2 Diabetes Prevention and Treatment: Efficacy, Mechanisms, and Practical Considerations. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of plant-based diets in promoting well-being in the management of type 2 diabetes: a systematic review. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Diet and Diabetic Kidney Disease: Plant Versus Animal Protein. [2022]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Implementation of a Whole Food Plant Based Diet in a Food as Prevention Program in a Resource Constrained Environment. [2023]

7. Canada 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. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Healthy plant-based diets and their short-term effects on weight loss, nutrient intake and serum cholesterol levels. [2022]