Intervention for Prediabetic State

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute, Montreal, Canada
Prediabetic State+7 More
Lifestyle changes - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Prediabetic State
  • Coronary Heart Disease (CHD)
  • Healthy Lifestyle Behaviors
  • Remission

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: at 3 and 6 months of the start of the intervention

Month 6
Evolution of the HOMA-IR between the start of the program, the end of intervention (3 months) and the follow-up visit (6 months).
Proportion of prediabetic participants (HbA1c ≥ 5.7% to 6.4% at the start of the program) in complete remission of prediabetes.
Month 6
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.

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Intervention
1 of 1
Experimental Treatment

36 Total Participants · 1 Treatment Group

Primary Treatment: Intervention · No Placebo Group · N/A

Intervention
Behavioral
Experimental Group · 1 Intervention: Lifestyle changes · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle changes
2012
Completed Phase 2
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 3 and 6 months of the start of the intervention

Trial Background

Louis Bherer, Director of Centre EPIC research lab
Principal Investigator
Montreal Heart Institute
Closest Location: Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute · Montreal, Canada
Photo of montreal  1Photo of montreal  2Photo of montreal  3
2019First Recorded Clinical Trial
1 TrialsResearching Prediabetic State
3 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have coronary heart disease.
You are able to perform a maximal exercise test and exercise training program in accordance with current cardiovascular rehabilitation recommendations.
You are able to use a smartphone application or to complete an adherence/compliance diary.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References