Screening for Glucose Metabolism Disorders in Cardiac Rehabilitation

Diabetes Clinical Trial

— REHABDIAB  

Official title:

Screening for Glucose Metabolism Disorders in Cardiac Rehabilitation After an Acute Coronary Syndrome (REHABDIAB [REHABilitation for Coronary Disease and DIABetes])

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03059550
• Other study ID #: CHUDijon
• Status: Recruiting
• Start date: March 1, 2013
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Bruno Vergès, MD, PhD
• Phone: +33 380 293453
• Email: bruno.verges[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 31, 2020
• Est. primary completion date: May 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Diabetes
• Glucose Metabolism Disorders
• Metabolic Diseases

Locations

Country	Name	City	State
France	CHU Dijon	Dijon	Burgundy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of OGTT performed after an acute coronary syndrome	Percentage of OGTT performed after an acute coronary syndrome	26 months
Secondary	Abnormalities of glucose metabolism diagnosed in cardiac rehabilitation	Abnormalities of glucose metabolism diagnosed in cardiac rehabilitation: diabetes, impaired glucose tolerance, impaired fasting glucose	26 months
Secondary	Profile of the patients according to their glucose abnormalities	Clinical, biological and peak workload in each category of patients, normoglycemic, patients with diabetes, patients with impaired glucose tolerance, patients with impaired fasting glucose	26 months