Effects of Plant-based Dietary Patterns on Diabetes Remission: the REmission of Diabetes Using a PlAnt-based Weight Loss InteRvention (REPAIR) Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Proportion achieving diabetes remission
研究概览
简要总结
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:
- Standard of care, where they will continue their usual diabetes care with their health care providers
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The statistician will be masked to the treatments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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
研究组 & 干预措施
plant-based intensive lifestyle 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.
干预措施: Plant-based intensive lifestyle intervention (Behavioral)
standard of care
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.
干预措施: Standard of Care (Other)
结局指标
主要结局
Proportion achieving diabetes remission
时间窗: From enrollment to the end of treatment at 52 weeks.
Proportion achieving diabetes remission, defined as an HbA1C \<6.5% for ≥3 months free of antihyperglycemic medications at 52 weeks.
次要结局
- Changes in functional tests(From enrollment to the end of treatment at 52 weeks.)
- Changes in measures of body composition(From enrollment to the end of treatment at 52 weeks.)
- Changes in glycemic control(From enrollment to the end of treatment at 52 weeks.)
- Key secondary: Proportion achieving ≥15% weight loss(From enrollment to the end of treatment at 52 weeks.)
- Proportion achieving ≥10% and ≥5% weight loss from baseline change(From enrollment to the end of treatment at 52 weeks)
- Proportion experiencing relapse(From enrollment to the end of treatment at 52 weeks.)
- Changes in blood lipids(From enrollment to the end of treatment at 52 weeks.)
- Changes in blood pressure(From enrollment to the end of treatment at 52 weeks.)
- Changes in inflammation(From enrollment to the end of treatment at 52 weeks)
研究者
Laura Chiavaroli
Assistant Professor
University of Toronto