NCT00354237

DARE: Diabetes in cArdiac REhabilitation

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 25 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus
• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	Conventional antidiabetic treatment	No intensive treatment
OTHER	Intensive insulin treatment	Intensive insulin treatment

Timeline

• Start date: 2005-07-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2006-07-20
• Last updated: 2014-11-18

Locations

12 sites across 1 country: France