DARE: Diabetes in cArdiac REhabilitation

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ClinicalTrials.gov Identifier: NCT00354237

Recruitment Status : Completed

First Posted : July 20, 2006

Last Update Posted : November 18, 2014

Sponsor:

Information provided by (Responsible Party):

Prof. Bruno Vergès, Centre Hospitalier Universitaire Dijon

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus Coronary Artery Disease	Other: Conventional antidiabetic treatment Other: Intensive insulin treatment	Not Applicable

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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.
Study Start Date :	July 2005
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Type 2 diabetes

MedlinePlus related topics: Cardiac Rehabilitation Coronary Artery Disease Rehabilitation

Drug Information available for: Insulin Insulin human

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
B No intensive treatment	Other: Conventional antidiabetic treatment No intensive treatment
Experimental: A Intensive insulin treatment	Other: Intensive insulin treatment Intensive insulin treatment

Outcome Measures

Primary Outcome Measures :

improvement of peak VO2, [ Time Frame: 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 :

number of patients, in each group of treatment, having improved from at least 16% their peak VO2, after cardiac rehabilitation. [ Time Frame: 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). [ Time Frame: at the beginning and at the end of the cardiac rehabilitation programm ]
improvement of ventilatory threshold [ Time Frame: 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

Eligibility Criteria

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Ages Eligible for Study:	25 Years to 95 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354237

Locations


France
Centre hospitalier du pays d'Aix
Aix en Provence, France, 13616
Clinique Rhône Durance
Avignon, France, 84082
Hôpital J Minjoz
Besancon, France, 25000
CMC Bligny
Briis Sous Forges, France, 91640
centre de réadaptation cardiaque "Château le moine"
Cenon, France, 33150
CHU du Bocage
Dijon, France, 21079
Centre IRIS
Marcy l'Etoile, France, 69280
Centre Hospitalier de MONTBARD
Montbard, France, 21506
Hopital BROUSSAIS, APHP
Paris, France, 75014
Hôpital du haut Lévêque
Pessac, France, 33604
Rééducation cardiovasculaire CRF Kerpape
Ploemeur, France, 56275
Hôpital jeanne d'arc
Toul, France, 54201

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators


Principal Investigator:	Bruno L Vergès, Prof	Centre Hospitalier Universitaire Dijon

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vergès B, Patois-Vergès B, Iliou MC, Simoneau-Robin I, Bertrand JH, Feige JM, Douard H, Catargi B, Fischbach M; DARE Study group. Influence of glycemic control on gain in VO2 peak, in patients with type 2 diabetes enrolled in cardiac rehabilitation after an acute coronary syndrome. The prospective DARE study. BMC Cardiovasc Disord. 2015 Jul 8;15:64. doi: 10.1186/s12872-015-0055-8.


Responsible Party:	Prof. Bruno Vergès, Professor, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:	NCT00354237 History of Changes
Other Study ID Numbers:	DGS2005/0130
First Posted:	July 20, 2006 Key Record Dates
Last Update Posted:	November 18, 2014
Last Verified:	November 2014

Keywords provided by Prof. Bruno Vergès, Centre Hospitalier Universitaire Dijon:


diabetes mellitus cardiac rehabilitation insulin

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Coronary Artery Disease Myocardial Ischemia Coronary Disease Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Heart Diseases	Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Insulin, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs

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