DARE: Diabetes in cArdiac REhabilitation

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Type 2 Diabetes Mellitus
• Interventions: Other: Conventional antidiabetic treatment; Other: Intensive insulin treatment

• Registration Number: NCT00354237
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2006-07-19
• Study First Submitted QC: 2006-07-19
• Study First Posted: 2006-07-20
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Conventional antidiabetic treatment	No intensive treatment
A	Intensive insulin treatment	Intensive insulin treatment

Primary Outcome Measures

Name	Time	Method
improvement of peak VO2,	at the beginning and at the end of the cardiac rehabilitation programm	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).

Secondary Outcome Measures

Name	Time	Method
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
improvement of ventilatory threshold	from the beginning and at the end of the cardiac rehabilitation programm	Effect of strict glycemic control during cardiac rehabilitation on improvement of ventilatory threshold
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

Trial Locations

Locations (12)

Hôpital J Minjoz; 🇫🇷 Besancon, France

Centre IRIS; 🇫🇷 Marcy l'Etoile, France

Centre hospitalier du pays d'Aix; 🇫🇷 Aix en Provence, France

Clinique Rhône Durance; 🇫🇷 Avignon, France

centre de réadaptation cardiaque "Château le moine"; 🇫🇷 Cenon, France

Centre Hospitalier de MONTBARD; 🇫🇷 Montbard, France

CHU du Bocage; 🇫🇷 Dijon, France

Hopital BROUSSAIS, APHP; 🇫🇷 Paris, France

Hôpital du haut Lévêque; 🇫🇷 Pessac, France

Rééducation cardiovasculaire CRF Kerpape; 🇫🇷 Ploemeur, France

Hôpital jeanne d'arc; 🇫🇷 Toul, France

CMC Bligny; 🇫🇷 Briis Sous Forges, France