the remission of diabetes using a plant-based weight loss intervention (repair) trial

Conditions: Diabetes Mellitus

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. 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


Eligibility criteria:
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 \ 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

Keywords: diabetes remission weight loss plant-based diet exercise intensive lifestyle intervention behavioural intervention digital program