Feasibility and Impact of an Intensive Team-based Intervention on Prediabetes Remission in Patients With Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Feasibility of an intensive multidisciplinary program based on lifestyle changes in coronary heart disease patients recently diagnosed with prediabetes that are referred to the Centre EPIC.
研究概览
简要总结
To evaluate the feasibility of a 6-month multidisciplinary program to reverse prediabetes in adults with coronary heart disease using the Mediterranean diet, intermittent fasting and exercise.
详细描述
The proposed study will assess the feasibility of an intensive lifestyle program to reverse newly onset prediabetes (HbA1c ≥ 5.7% to 6.4%) in patients with coronary heart disease that would otherwise start a standard cardiac rehabilitation programme (12 weeks with twice weekly exercise, nutrition, and nursing counselling). The patients will be offered an upgraded 6-month intensive team-based multidisciplinary stepwise program with the goal of remitting prediabetes. The program will consist of a 3-month synchronous nutritional, exercise, and motivational intervention and of a 3-month maintenance and follow-up period.
The DIABEPIC prevent 1 study is a single-arm, open-label study aiming to demonstrate the feasibility of an intensive multidisciplinary stepwise intervention in newly diagnosed prediabetic and coronary heart disease patients, ultimately aiming to remit prediabetes.
The purpose of this first study is to devise and iteratively improve participant recruitment and adherence strategies for a possible future randomized controlled trial. It also includes as goals: to study the efficacy and adherence of an intensive multicomponent lifestyle intervention, to study the proportion of patients that improve or remit their insulin resistant state, to study the changes in a variety of anthropomorphic, physical, analytic, vascular and test parameters and to better characterize the factors associated with prediabetes remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary heart disease patients referred from the Montreal Heart Institute.
- •Aged ≥ 40 years.
- •Recently diagnosed prediabetes (HbA1c ≥ 5.7% to 6.4%) in the last 6 months.
- •Referred to Centre EPIC because of stable angina, acute coronary syndrome (with or without ST elevation), after coronary revascularization (primary or elective) or bypass surgery.
- •Able to perform a maximal exercise test and exercise training program in accordance with current cardiovascular rehabilitation recommendations.
- •Able to use a smartphone application or to complete an adherence/compliance diary.
- •Able to read, understand and sign the information and consent form.
排除标准
- •Absolute and relative contraindication to exercise testing and/or physical training.
- •Diabetic patients (HbA1c ≥ 6.5%) or patients with a HbA1c value of ≥ 5.7% to 6.4% but with the help of oral hypoglycemic agents.
- •Taking psychotropic medications that may induce mass gain (tricyclic antidepressants, mirtazapine, paroxetine, lithium, valproate, clozapine, olanzapine) or other medications known to promote mass gain (cortisone).
- •Taking recently introduced weight-loss medications (semaglutide).
- •Unintentional mass loss of more than 10 kg in the past year.
- •Pregnant or nursing women.
结局指标
主要结局
Feasibility of an intensive multidisciplinary program based on lifestyle changes in coronary heart disease patients recently diagnosed with prediabetes that are referred to the Centre EPIC.
时间窗: at 6 months after the start of the intervention
Total recruitment, recruitment rate, compliance and completion rate at 6 months after the start of the intervention
次要结局
- Evolution of the HOMA-IR between the start of the program, the end of intervention (3 months) and the follow-up visit (6 months).(at 3 and 6 months of the start of the intervention)
- Proportion of prediabetic participants (HbA1c ≥ 5.7% to 6.4% at the start of the program) in complete remission of prediabetes.(at 3 and 6 months of the start of the intervention)
研究者
Louis Bherer
Director of Centre EPIC research lab
Montreal Heart Institute