Feasibility of Prediabetes Remission in Adults With Coronary Heart Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility and Impact of an Intensive Team-based Intervention on Prediabetes Remission in Patients With Coronary Heart Disease

Conditions
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Prediabetic State, Coronary Heart Disease, Healthy Lifestyle, Remission

Intervention / Treatment
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* Behavioral: Lifestyle changes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Behavioral: Lifestyle changes Nutritional advice to progressively integrate a moderate-carbohydrate Mediterranean diet with intermittent fasting 16:8 (5 times/week for 12 weeks). Personalized exercise prescription and training (3 times per week) Personalized education and motivational interviewing | Behavioral: Lifestyle changes<br>* Nutritional advice to progressively integrate a moderate-carbohydrate Mediterranean diet with intermittent fasting 16:8 (5 times/week for 12 weeks). Personalized exercise prescription and training (3 times per week) Personalized education and motivational interviewing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Total recruitment, recruitment rate, compliance and completion rate at 3 months after the start of the intervention | at 3 months after the start of the intervention | 
| 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. | Total recruitment, recruitment rate, compliance and completion rate at 6 months after the start of the intervention | at 6 months after the start of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of prediabetic participants (HbA1c ≥ 5.7% to 6.4% at the start of the program) in complete remission of prediabetes. | Remission of prediabetes will be defined by the following 3 criteria: An HbA1c < 5.7% at 3 months of intervention (Metabolic criteria). Which is maintained at 6 months (Duration criteria). Without the use of glucose-lowering agents (pharmacological criteria). Proportion of prediabetic patients that reach an HbA1c < 5.7% at 6 months of intervention will also be studied | at 3 and 6 months of the start of the intervention | 
| Evolution of the HOMA-IR between the start of the program, the end of intervention (3 months) and the follow-up visit (6 months). | HOMA-IR is a marker of insulin resistance | at 3 and 6 months of the start of the intervention |