Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-04-18 @ 10:32 PM
Study NCT ID:
NCT03059550
Status:
UNKNOWN
Last Update Posted:
2018-07-19
First Post:
2017-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Glucose Metabolism Disorders in Cardiac Rehabilitation
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Study Overview
Official Title:
Screening for Glucose Metabolism Disorders in Cardiac Rehabilitation After an Acute Coronary Syndrome (REHABDIAB [REHABilitation for Coronary Disease and DIABetes])
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REHABDIAB
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: