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Screening for Glucose Metabolism Disorders in Cardiac Rehabilitation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03059550
Acronym
REHABDIAB
Enrollment
350
Registered
2017-02-23
Start date
2013-03-01
Completion date
2020-12-31
Last updated
2018-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

cardiac rehabilitation, prediabetes

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.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Percentage of OGTT performed after an acute coronary syndrome26 monthsPercentage of OGTT performed after an acute coronary syndrome

Secondary

MeasureTime frameDescription
Abnormalities of glucose metabolism diagnosed in cardiac rehabilitation26 monthsAbnormalities of glucose metabolism diagnosed in cardiac rehabilitation: diabetes, impaired glucose tolerance, impaired fasting glucose
Profile of the patients according to their glucose abnormalities26 monthsClinical, biological and peak workload in each category of patients, normoglycemic, patients with diabetes, patients with impaired glucose tolerance, patients with impaired fasting glucose

Countries

France

Contacts

Primary ContactBruno Vergès, MD, PhD
bruno.verges@chu-dijon.fr+33 380 293453

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026