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Behavioral Intervention

Lifestyle changes for Prediabetes (DIABEPIC1 Trial)

N/A
Waitlist Available
Led By Louis Bherer, PhD
Research Sponsored by Montreal Heart Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to perform a maximal exercise test and exercise training program in accordance with current cardiovascular rehabilitation recommendations.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 and 6 months of the start of the intervention
Awards & highlights

DIABEPIC1 Trial Summary

This trial is testing if a 6-month program of the Mediterranean diet, intermittent fasting, and exercise can help people with coronary heart disease who have prediabetes.

Eligible Conditions
  • Prediabetes
  • Remission
  • Healthy Lifestyle
  • Coronary Heart Disease

DIABEPIC1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are capable of completing a challenging exercise test and following an exercise program recommended for cardiovascular rehabilitation.

DIABEPIC1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 and 6 months of the start of the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 and 6 months of the start of the intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
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.

DIABEPIC1 Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle changes
2012
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Montreal Heart InstituteLead Sponsor
120 Previous Clinical Trials
68,783 Total Patients Enrolled
Louis Bherer, PhDPrincipal InvestigatorUniversité de Montréal
8 Previous Clinical Trials
755 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation still recruiting participants?

"Affirmative. According to data posted on clinicaltrials.gov, this medical trial commenced recruiting on March 15th 2022 and was last updated July 12th 2022. 36 volunteers must be found across 1 facility for the study's completion."

Answered by AI

How many individuals are currently taking part in this clinical trial?

"Confirmed. According to records on clinicaltrials.gov, this medical study is actively recruiting patients from March 15th 2022 and was most recently updated July 12th 2022. The research seeks 36 volunteers at a single site."

Answered by AI
Recent research and studies
~12 spots leftby Apr 2025