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DARE: Diabetes in cArdiac REhabilitation

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Coronary Artery Disease
Type 2 Diabetes Mellitus

Treatments

Other: Intensive insulin treatment
Other: Conventional antidiabetic treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT00354237
DGS2005/0130

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

25 to 95 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

B
Other group
Description:
No intensive treatment
Treatment:
Other: Conventional antidiabetic treatment
A
Experimental group
Description:
Intensive insulin treatment
Treatment:
Other: Intensive insulin treatment

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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