- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03059550
Screening for Glucose Metabolism Disorders in Cardiac Rehabilitation (REHABDIAB)
Screening for Glucose Metabolism Disorders in Cardiac Rehabilitation After an Acute Coronary Syndrome (REHABDIAB [REHABilitation for Coronary Disease and DIABetes])
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Bruno Vergès, MD, PhD
- Phone Number: +33 380 293453
- Email: bruno.verges@chu-dijon.fr
Study Locations
-
-
Burgundy
-
Dijon, Burgundy, France, 21000
- Recruiting
- CHU Dijon
-
Contact:
- Vergès Bruno, MD, PhD
- Phone Number: +33 380 293453
- Email: bruno.verges@chu-dijon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients referred to cardiac rehabilitation after an acute coronary syndrome during the 6 precious weeks
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
cardiac rehabilitation
Patients reffered to cardiac Rehabilitation after an acute coronary syndrome
|
Whole French population post-ACS
The whole French population who presented an acute coronary syndrome (ACS) in the years 2013 and 2014.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of OGTT performed after an acute coronary syndrome
Time Frame: 26 months
|
Percentage of OGTT performed after an acute coronary syndrome
|
26 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abnormalities of glucose metabolism diagnosed in cardiac rehabilitation
Time Frame: 26 months
|
Abnormalities of glucose metabolism diagnosed in cardiac rehabilitation: diabetes, impaired glucose tolerance, impaired fasting glucose
|
26 months
|
Profile of the patients according to their glucose abnormalities
Time Frame: 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
|
26 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bruno Vergès, MD, PhD, CHU Dijon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUDijon
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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