Screening for Glucose Metabolism Disorders in Cardiac Rehabilitation

NCT ID: NCT03059550

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-01
• Study Completion Date: 2020-12-31

Brief Summary

Because prevalence of glucose metabolism disorders is high in patients with coronary disease, the Oral Glucose Tolerance Test (OGTT) is recommended in all patients without diabetes after an acute coronary syndrome (ACS). However, there are some concerns about its performance in clinical practice. The aim of our study was to evaluate, after an acute coronary syndrome (ACS), the feasibility and efficacy of the OGTT in a cardiac rehabilitation (CR) center in comparison with its real application in the whole French population.

Detailed Description

We will select all the patients referred to our Cardiac Rehabilitation center after an ACS. HbA1c will be measured in each patient included in the study. the OGTT will be prescribed in all the patients without known diabetes and with HbA1c < 6.5%. In order to perform a "real life" study, the OGTT will not performed in the CR center but will prescribed in each patient who will be asked to perform it in an external biological laboratory.

The OGTT will be performed in the morning after a 12 hour fast, with 75g oral glucose load. Plasma glucose will be measured at baseline and 120 min after the oral glucose load. The results will be classified according to the WHO criteria: diabetes is defined as fasting plasma glucose (FPG) greater or equal to 7.0 mmol/L (126 mg/dL) or glucose level 2h (2hPG) after the OGTT greater or equal to 11.1mmol/L (200mg/dL); impaired fasting glucose (IFG) is defined as FPG greater or equal to 6.1 mmol/L (110mg/dL) and less than 7.0 mmol/L and impaired glucose tolerance (IGT) is defined as a 2hPG greater or equal to 7.8 mmol/L (140 mg/dL) and less than 11.1mmol/L.

In parallel, screening for glucose metabolism disorders with the OGTT after an ACS will be evaluated in the whole French population from a representative sample of 1/97ème French population of the "National Health Insurance Inter-Regime Information System" (SNIIRAM) which collects individual hospital and non-hospital data for health care consumption.

Conditions

Diabetes

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

cardiac rehabilitation

Patients reffered to cardiac Rehabilitation after an acute coronary syndrome

No interventions assigned to this group

Whole French population post-ACS

The whole French population who presented an acute coronary syndrome (ACS) in the years 2013 and 2014.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• patients referred to cardiac rehabilitation after an acute coronary syndrome during the 6 precious weeks

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Prof. Bruno Vergès

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruno Vergès, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Dijon

Locations

CHU Dijon

Dijon, Burgundy, France

Site Status: RECRUITING

Countries

France

Central Contacts

Bruno Vergès, MD, PhD

Role: CONTACT

bruno.verges@chu-dijon.fr

+33 380 293453

Facility Contacts

Vergès Bruno, MD, PhD

Role: primary

bruno.verges@chu-dijon.fr

+33 380 293453

Other Identifiers

CHUDijon

Identifier Type: -

Identifier Source: org_study_id