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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
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

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

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.

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
2020
Completed Phase 2
~210

Find a Location

Who is running the clinical trial?

Montreal Heart InstituteLead Sponsor
122 Previous Clinical Trials
78,724 Total Patients Enrolled
Louis Bherer, PhDPrincipal InvestigatorUniversité de Montréal
8 Previous Clinical Trials
755 Total Patients Enrolled
~11 spots leftby Jul 2025
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