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"DARE" : Diabetes in Cardiac Rehabilitation

This study is currently recruiting participants.
Verified by Centre Hospitalier Universitaire Dijon May 2006

Sponsored by:

Centre Hospitalier Universitaire Dijon

Information provided by:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT00354237

 

Purpose

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.

Condition

Intervention

Type 2 Diabetes Mellitus
Coronary Artery Disease

 Procedure: Intensive Insulin treatment

 

MedlinePlus related topics:  Coronary Artery Disease;   Diabetes
Genetics Home Reference related topics:  Coronary Artery Disease

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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.

Primary Outcome Measures: 

  • improvement of peak VO2,
  • improvement of peak workload
  • improvement of ventilatory threshold


Secondary Outcome Measures: 

  • number of patients, in each group of treatment, having improved from at least 20% their peak VO2, after cardiac rehabilitation.
  • 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).

Further study details as provided by Centre Hospitalier Universitaire Dijon:


Total Enrollment:  440

Study start: July 2005;  Expected completion: December 2007

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.

 

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