DARE: Diabetes in cArdiac REhabilitation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Bruno Vergès, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT00354237
First received: July 19, 2006
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Coronary Artery Disease
Other: Conventional antidiabetic treatment
Other: Intensive insulin treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • improvement of peak VO2, [ Time Frame: at the beginning and at the end of the cardiac rehabilitation programm ] [ Designated as safety issue: No ]
  • improvement of peak workload [ Time Frame: at the beginning and at the end of the cardiac rehabilitation programm ] [ Designated as safety issue: No ]
  • improvement of ventilatory threshold [ Time Frame: at the beginning and at the end of the cardiac rehabilitation programm ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2005
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
B
No intensive treatment
Other: Conventional antidiabetic treatment
No intensive treatment
Experimental: A
Intensive insulin treatment
Other: Intensive insulin treatment
Intensive insulin treatment

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.

  Eligibility

Ages Eligible for Study:   25 Years to 95 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Prof. Bruno Vergès, Professor, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT00354237     History of Changes
Other Study ID Numbers: DGS2005/0130
Study First Received: July 19, 2006
Last Updated: July 25, 2014
Health Authority: France: Ministry of Health

Keywords provided by Centre Hospitalier Universitaire Dijon:
diabetes mellitus
cardiac rehabilitation
insulin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014