The REmission of Diabetes Using a PlAnt-based Weight Loss InteRvention (REPAIR) Trial

Официальное название

Effects of Plant-based Dietary Patterns on Diabetes Remission: the REmission of Diabetes Using a PlAnt-based Weight Loss InteRvention (REPAIR) Trial

Обзор

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

Вмешательства

• Поведенческое Plant-based intensive lifestyle intervention
  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, progre
• Другое Standard of Care
  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 c

Первичные конечные точки

• Proportion achieving diabetes remission [Срок оценки: From enrollment to the end of treatment at 52 weeks.]

Вторичные конечные точки (12)

• Key secondary: Proportion achieving ≥15% weight loss [Срок оценки: From enrollment to the end of treatment at 52 weeks.]
• Proportion achieving ≥10% and ≥5% weight loss from baseline change [Срок оценки: From enrollment to the end of treatment at 52 weeks]
• Changes in measures of body composition [Срок оценки: From enrollment to the end of treatment at 52 weeks.]
• Changes in measures of body composition [Срок оценки: From enrollment to the end of treatment at 52 weeks.]
• Changes in measures of body composition [Срок оценки: From enrollment to the end of treatment at 52 weeks.]
• Changes in measures of body composition [Срок оценки: From enrollment to the end of treatment at 52 weeks.]
• Changes in measures of body composition [Срок оценки: From enrollment to the end of treatment at 52 weeks.]
• Proportion experiencing relapse [Срок оценки: From enrollment to the end of treatment at 52 weeks.]
• Changes in functional tests [Срок оценки: From enrollment to the end of treatment at 52 weeks.]
• Changes in functional tests [Срок оценки: From enrollment to the end of treatment at 52 weeks.]
• Changes in glycemic control [Срок оценки: From enrollment to the end of treatment at 52 weeks.]
• Changes in glycemic control [Срок оценки: From enrollment to the end of treatment at 52 weeks.]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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;
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Unity Health Toronto (St. Michael's Hospital) — Toronto

Идентификаторы

NCT: NCT06906172 · REB 24-227

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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