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Feasibility of Prediabetes Remission in Adults With Coronary Heart Disease — DIABEPIC1  

Coronary Heart Disease Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05459987
Study type Interventional
Source Montreal Heart Institute
Contact
Status Completed
Phase N/A
Start date March 15, 2022
Completion date June 15, 2023
View Details
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