DARE: Diabetes in cArdiac REhabilitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Type 2 Diabetes Mellitus, Coronary Artery Disease

Intervention / Treatment
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* Other: Conventional antidiabetic treatment
* Other: Intensive insulin treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: B<br>No intensive treatment | Other: Conventional antidiabetic treatment<br>* No intensive treatment<br>|
| Experimental: A<br>Intensive insulin treatment | Other: Intensive insulin treatment<br>* Intensive insulin treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of peak VO2, | Effect of strict glycemic control during cardiac rehabilitation on improvement of peak VO2.For this purpose, we paln to compare first the 2 treatment groups (intensive vs. control) and second, 2 pre-specified glycemic control groups according to the final fructosamine level (below and above the median). | at the beginning and at the end of the cardiac rehabilitation programm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients, in each group of treatment, having improved from at least 16% their peak VO2, after cardiac rehabilitation. |  | at the beginning and at the end of the cardiac rehabilitation programm | 
| 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). |  | at the beginning and at the end of the cardiac rehabilitation programm | 
| improvement of ventilatory threshold | Effect of strict glycemic control during cardiac rehabilitation on improvement of ventilatory threshold | from the beginning and at the end of the cardiac rehabilitation programm | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, cardiac rehabilitation, insulin