Rationale and design of a parallel randomised trial of a plant-based intensive lifestyle intervention for diabetes remission: The REmission of diabetes using a PlAnt-based weight loss InteRvention (REPAIR) trial

Brighid McKay^{1

2}, Dayana El Chaar^{1

2}, Melanie Paquette^{1

2}, Michael Vallis³, Diana Sherifali^{4

5}, Paul Oh⁶, Susan Marzolini⁶, Kaberi Dasgupta⁷, Gillian Booth^{8

9

10}, Mike Lean¹¹, Hertzel C Gerstein¹², Jordi Salas-Salvadó^{13

14

15}, Jacqueline L Beaudry¹, Christopher P F Marinangeli¹⁶, Russell J de Souza^{12

17

18}, Lawrence A Leiter^{1

2

9

19

20}, Cyril W C Kendall^{1

2

21}, David J A Jenkins^{1

2

9

19

20}, John L Sievenpiper^{1

2

9

19

20}, Laura Chiavaroli^{1

2

19}

Affiliations

¹ Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
² Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.
³ Department of Family Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
⁴ School of Nursing, McMaster University, Hamilton, Ontario, Canada.
⁵ McMaster Evidence Review and Synthesis Team, McMaster University, Hamilton, Ontario, Canada.
⁶ Toronto Rehabilitation Institute, KITE Research Institute, Toronto, Ontario, Canada.
⁷ Department of Medicine, McGill University and Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
⁸ MAP Centre for Urban Health Solutions, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.
⁹ Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
¹⁰ Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
¹¹ Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
¹² Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
¹³ Departament de Bioquímica i Biotecnologia, Universitat Rovira i Virgili, Reus, Tarragona, Spain.
¹⁴ Instituto de Salud Carlos III, CIBER Fisiopatología de la Obesidad y Nutrición (CIBERobn), Madrid, Spain.
¹⁵ Institut d'Investigació Sanitària Pere Virgili (IISPV), Reus, Spain.
¹⁶ Centre for Regulatory Research and Innovation, Protein Industries Canada, Regina, Saskatchewan, Canada.
¹⁷ Mary Heersink School of Global Health and Social Medicine, McMaster University, Hamilton, Ontario, Canada.
¹⁸ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
¹⁹ Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.
²⁰ Division of Endocrinology and Metabolism, Department of Medicine, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.
²¹ College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.

PMID: 41623136
DOI: 10.1111/dom.70510

Rationale and design of a parallel randomised trial of a plant-based intensive lifestyle intervention for diabetes remission: The REmission of diabetes using a PlAnt-based weight loss InteRvention (REPAIR) trial

Brighid McKay et al. Diabetes Obes Metab. 2026.

. 2026 Feb 2.

doi: 10.1111/dom.70510. Online ahead of print.

Authors

Affiliations

¹ Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
² Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.
³ Department of Family Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
⁴ School of Nursing, McMaster University, Hamilton, Ontario, Canada.
⁵ McMaster Evidence Review and Synthesis Team, McMaster University, Hamilton, Ontario, Canada.
⁶ Toronto Rehabilitation Institute, KITE Research Institute, Toronto, Ontario, Canada.
⁷ Department of Medicine, McGill University and Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
⁸ MAP Centre for Urban Health Solutions, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.
⁹ Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
¹⁰ Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
¹¹ Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
¹² Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
¹³ Departament de Bioquímica i Biotecnologia, Universitat Rovira i Virgili, Reus, Tarragona, Spain.
¹⁴ Instituto de Salud Carlos III, CIBER Fisiopatología de la Obesidad y Nutrición (CIBERobn), Madrid, Spain.
¹⁵ Institut d'Investigació Sanitària Pere Virgili (IISPV), Reus, Spain.
¹⁶ Centre for Regulatory Research and Innovation, Protein Industries Canada, Regina, Saskatchewan, Canada.
¹⁷ Mary Heersink School of Global Health and Social Medicine, McMaster University, Hamilton, Ontario, Canada.
¹⁸ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
¹⁹ Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.
²⁰ Division of Endocrinology and Metabolism, Department of Medicine, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.
²¹ College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.

PMID: 41623136
DOI: 10.1111/dom.70510

Abstract

Aims: As type 2 diabetes (T2D) continues to rise globally and remains a major driver of cardiovascular disease, its remission has emerged as a therapeutic target. Current evidence supports bariatric surgery and low-calorie diets with meal replacements. No clinical trial to date has evaluated plant-based dietary alternatives as an intensive lifestyle intervention (ILI) strategy, despite the emphasis on plant-based diets in current clinical practice guidelines for diabetes and cardiovascular disease. The REmission of diabetes using a PlAnt-based weight loss InteRvention (REPAIR) trial will assess whether a 52-week plant-based ILI targeting ≥15% weight loss is effective for diabetes remission in a multi-ethnic Canadian population.

Materials and methods: The REPAIR trial is a prospective, randomised, 2-arm, open-label, blinded-endpoint efficacy trial. Participants will include 160 adults with early T2D (<6 years) and living with obesity. They will be randomised to standard of care or a 2-phase ILI targeting ≥15% weight loss consisting of a 12-week weight loss phase on a plant-based total diet meal replacement, followed by a 40-week weight loss maintenance phase on a plant-based dietary pattern combined with a 16-week structured exercise program, and a 52-week (19-session) sustainable behaviour change curriculum. The primary outcome is diabetes remission (HbA1c <6.5% without glucose-lowering medication for ≥3 months) and the key secondary outcome is the proportion achieving ≥15% weight loss at 52 weeks.

Conclusions: This trial will provide high-quality clinical evidence on the use of plant-based ILIs to address the epidemics of obesity and diabetes to inform public health policies and programs in Canada and beyond.

Keywords: clinical trial; dietary intervention; exercise intervention; plant‐based; type 2 diabetes; weight management.

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References

REFERENCES

1. Sun H, Saeedi P, Karuranga S, et al. IDF Diabetes Atlas: Global, regional and country‐level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022;183:109119. doi:10.1016/j.diabres.2021.109119
1. Magliano DJ, Boyko EJ, Committee IDFDAtes. IDF Diabetes Atlas. IDF Diabetes Atlas. International Diabetes Federation; 2021.
1. Doucet G, Beatty M. The cost of diabetes in Canada: the economic tsunami. Can J Diabetes. 2010;34(1):27‐29.
1. Health Canada. Updated 2024‐02‐29. Universal Access to Diabetes Medications, and Diabetes Device Fund for Devices and Supplies. Accessed August 2025, https://www.canada.ca/en/health‐canada/news/2024/02/universal‐access‐to‐...
1. International Diabetes Federation. IDF Diabetes Atlas teB, Belgium: International Diabetes Federation. 2025 Available at: https://diabetesatlas.org

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Rationale and design of a parallel randomised trial of a plant-based intensive lifestyle intervention for diabetes remission: The REmission of diabetes using a PlAnt-based weight loss InteRvention (REPAIR) trial

Affiliations

Rationale and design of a parallel randomised trial of a plant-based intensive lifestyle intervention for diabetes remission: The REmission of diabetes using a PlAnt-based weight loss InteRvention (REPAIR) trial

Authors

Affiliations

Abstract

References

REFERENCES

Grants and funding

LinkOut - more resources

Full Text Sources

Research Materials