Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03059550
Status:
UNKNOWN
Last Update Posted:
2018-07-19
First Post:
2017-02-16
Brief Title:
Screening for Glucose Metabolism Disorders in Cardiac Rehabilitation
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
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 65 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 70 mmolL 126 mgdL or glucose level 2h 2hPG after the OGTT greater or equal to 111mmolL 200mgdL impaired fasting glucose IFG is defined as FPG greater or equal to 61 mmolL 110mgdL and less than 70 mmolL and impaired glucose tolerance IGT is defined as a 2hPG greater or equal to 78 mmolL 140 mgdL and less than 111mmolL
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 197ème 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 70 mmolL 126 mgdL or glucose level 2h 2hPG after the OGTT greater or equal to 111mmolL 200mgdL impaired fasting glucose IFG is defined as FPG greater or equal to 61 mmolL 110mgdL and less than 70 mmolL and impaired glucose tolerance IGT is defined as a 2hPG greater or equal to 78 mmolL 140 mgdL and less than 111mmolL
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 197ème 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:
None
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?:
None