Clinical trial NCT00354237: DARE: Diabetes in cArdiac REhabilitation
Official title: Effect of Strict Glycemic Control on Improvement of Exercise Capacities (VO2 Peak, Peak Workload After Cardiac Rehabilitation, in Patients With Type 2 Diabetes Mellitus With Coronary Artery Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Coronary Artery Disease
Keywords: diabetes mellitus
cardiac rehabilitation
insulin
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2006-07-20
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the DARE study is to see whether strict glycemic control during cardiac rehabilitation may ameliorate the improvement of exercise capacities (VO2 peak, peak workload, ventilatory threshold)in patients with type 2 diabetes with coronary artery disease.

Detailed description: In a recent study, we showed that the benefit of cardiac rehabilitation on the improvement of exercise capacities (VO2 peak, peak workload, ventilatory threshold), after an acute coronary event, was significantly reduced in patients with type 2 diabetes. Moreover ,we showed, in multivariate analysis, that the worse improvement of the capacities to the effort after cardiac rehabilitation, was mainly related to hyperglycemia.

Because the improvement of exercise capacities after cardiac rehabilitation (in particular VO2 peak) has been shown to be an essential factor to reduce short- term and long-term morbidity and mortality, we may think that such benefit on reduction of morbidity and mortality may be significantly less in patients with diabetes.

Thus, we propose to carry out a multicentric intervention study, entitled DARE which goal is to see whether a strict glycemic control, during cardiac rehabilitation following an acute Myocardial Infarction (MI), is likely to improve, the results of cardiac rehabilitation on exercise capacities in patients with type 2 diabetes.

After arrival in cardiac rehabilitation, patients with diabetes, will be randomized into 2 groups: an "intensive treatment" group, in which the patients will treated by insulin under a basal-bolus regimen with strict glycemic control and a "conventional treatment" group, in which the previous anti-diabetic treatment will be continued.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* recent Miocardial Infarction
* HbA1c above 7%
* enrolled in a cardiac rehabilitation program

Exclusion Criteria:

* Type 1 diabetes
* Coronary Bypass Surgery
* Renal Failure (creatinine clearance below 30 ml/min)
* severe Respiratory Failure

Primary outcomes:
measure: improvement of peak VO2,
timeFrame: at the beginning and at the end of the cardiac rehabilitation programm
Secondary outcomes:
measure: number of patients, in each group of treatment, having improved from at least 16% their peak VO2, after cardiac rehabilitation.
timeFrame: at the beginning and at the end of the cardiac rehabilitation programm
measure: study of the influence of improvement of glycemic control on the results of cardiac rehabilitation on exercise capacities (peak of VO2, peak workload , ventilatory threshold).
timeFrame: at the beginning and at the end of the cardiac rehabilitation programm
measure: improvement of ventilatory threshold
timeFrame: from the beginning and at the end of the cardiac rehabilitation programm
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Centre hospitalier du pays d'Aix
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Besancon
country: France
facility: Hôpital J Minjoz
city: Briis Sous Forges
country: France
facility: CMC Bligny
city: Cenon
country: France
facility: centre de réadaptation cardiaque "Château le moine"
city: Dijon
country: France
facility: CHU du Bocage
city: Marcy l'Etoile
country: France
facility: Centre IRIS
city: Montbard
country: France
facility: Centre Hospitalier de MONTBARD
city: Paris
country: France
facility: Hopital BROUSSAIS, APHP
city: Pessac
country: France
facility: Hôpital du haut Lévêque
city: Ploemeur
country: France
facility: Rééducation cardiovasculaire CRF Kerpape
city: Toul
country: France
facility: Hôpital jeanne d'arc
Study officials:
affiliation: Centre Hospitalier Universitaire Dijon
name: Bruno L Vergès, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verges B, Patois-Verges B, Iliou MC, Simoneau-Robin I, Bertrand JH, Feige JM, Douard H, Catargi B, Fischbach M; DARE Study group. Influence of glycemic control on gain in VO2 peak, in patients with type 2 diabetes enrolled in cardiac rehabilitation after an acute coronary syndrome. The prospective DARE study. BMC Cardiovasc Disord. 2015 Jul 8;15:64. doi: 10.1186/s12872-015-0055-8.