Feasibility of Prediabetes Remission in Adults With Coronary Heart Disease (DIABEPIC1)

November 19, 2023 updated by: Louis Bherer, Montreal Heart Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T1N6
        • Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

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

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

What is the study measuring?

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.
Time Frame: at 3 months after the start of the intervention
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.
Time Frame: 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
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.
Time Frame: at 3 and 6 months of the start of the intervention

Remission of prediabetes will be defined by the following 3 criteria:

  1. An HbA1c < 5.7% at 3 months of intervention (Metabolic criteria).
  2. Which is maintained at 6 months (Duration criteria).
  3. 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).
Time Frame: at 3 and 6 months of the start of the intervention
HOMA-IR is a marker of insulin resistance
at 3 and 6 months of the start of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Investigators

  • Principal Investigator: Louis Bherer, PhD, Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

July 12, 2022

First Posted (Actual)

July 15, 2022

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 19, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM 2022-3005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If sponsor OK, we would agree with making individual data available to other researchers

IPD Sharing Time Frame

One year after completion of the study

IPD Sharing Access Criteria

Upon request to the principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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