DARE: Diabetes in cArdiac REhabilitation

Coronary Artery Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354237
• Other study ID #: DGS2005/0130
• Status: Completed
• Phase: N/A
• First received: July 19, 2006
• Last updated: November 17, 2014
• Start date: July 2005
• Est. completion date: December 2012

Study information

• Verified date: November 2014
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Myocardial Ischemia
• Type 2 Diabetes Mellitus

Intervention

Other:
• Conventional antidiabetic treatment
No intensive treatment
• Intensive insulin treatment
Intensive insulin treatment

Locations

Country	Name	City	State
France	Centre hospitalier du pays d'Aix	Aix en Provence
France	Clinique Rhône Durance	Avignon
France	Hôpital J Minjoz	Besancon
France	CMC Bligny	Briis Sous Forges
France	centre de réadaptation cardiaque "Château le moine"	Cenon
France	CHU du Bocage	Dijon
France	Centre IRIS	Marcy l'Etoile
France	Centre Hospitalier de MONTBARD	Montbard
France	Hopital BROUSSAIS, APHP	Paris
France	Hôpital du haut Lévêque	Pessac
France	Rééducation cardiovasculaire CRF Kerpape	Ploemeur
France	Hôpital jeanne d'arc	Toul

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No