Screening for Glucose Metabolism Disorders in Cardiac Rehabilitation

• Conditions: Diabetes

• Registration Number: NCT03059550
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Study Timeline

• Study Start: 2013-03-01
• Primary Completion: 2015-05-31
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-19
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of OGTT performed after an acute coronary syndrome	26 months	Percentage of OGTT performed after an acute coronary syndrome

Secondary Outcome Measures

Name	Time	Method
Abnormalities of glucose metabolism diagnosed in cardiac rehabilitation	26 months	Abnormalities of glucose metabolism diagnosed in cardiac rehabilitation: diabetes, impaired glucose tolerance, impaired fasting glucose
Profile of the patients according to their glucose abnormalities	26 months	Clinical, biological and peak workload in each category of patients, normoglycemic, patients with diabetes, patients with impaired glucose tolerance, patients with impaired fasting glucose

Trial Locations

Locations (1)

CHU Dijon; 🇫🇷 Dijon, Burgundy, France