DARE: Diabetes in cArdiac REhabilitation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Centre Hospitalier Universitaire Dijon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT00354237
First received: July 19, 2006
Last updated: May 6, 2008
Last verified: May 2008
  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 20% 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 ]

Estimated Enrollment: 440
Study Start Date: July 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: B
Usual antidiabetic treatment
Other: Conventional antidiabetic treatment
Usual antidiabetic 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

Contacts
Contact: Bruno L Vergès, Prof., MD 33 380293453 bruno.verges@chu-dijon.fr

Locations
France
Centre hospitalier du pays d'Aix Recruiting
Aix en Provence, France, 13616
Contact: B DELENNE, Dr    33442339227    bdelenne@ch-aix.fr   
Sub-Investigator: B DELENNE, Dr         
Principal Investigator: C CABANOT-SARRAU, Dr         
Clinique Rhône Durance Recruiting
Avignon, France, 84082
Contact: Jean M FEIGE, Dr    33490148181    scp-cardio.orange@wanadoo.fr   
Principal Investigator: Jean M FEIGE, Dr         
Sub-Investigator: J H BERTRAND, Dr         
Hôpital J Minjoz Recruiting
Besancon, France, 25000
Contact: P KRAMARZ, Dr    333 81 41 80 68    phil.kramarz.ub@wanadoo.fr   
Principal Investigator: P KRAMARZ, Dr         
Sub-Investigator: F PENFORNIS, Pr         
Sub-Investigator: CLERGEOT-BEGEY, Dr         
CMC Bligny Recruiting
Briis Sous Forges, France, 91640
Contact: S HARDY, Dr    33169263057    s.hardy@cm-bligny.com   
Principal Investigator: S HARDY, Dr         
centre de réadaptation cardiaque "Château le moine" Recruiting
Cenon, France, 33150
Contact: M FISCHBACH, Dr    33556334300    michel-fischbach@numericable.fr   
Principal Investigator: M FISCHBACH, Dr         
CHU du Bocage Recruiting
Dijon, France, 21079
Contact: B VERGES, Prof    33380293453    bruno.verges@chu-dijon.fr   
Principal Investigator: Bruno VERGES, Prof         
Sub-Investigator: Benedicte VERGES, Dr         
Centre IRIS Recruiting
Marcy l'Etoile, France, 69280
Contact: B PIERRE, Dr    33478874492    b.pierre@gsante.fr   
Principal Investigator: B PIERRE, Dr         
Sub-Investigator: E ROUSSET-LECOQUIL, Dr         
Sub-Investigator: L GROISNE, Dr         
Centre Hospitalier de MONTBARD Recruiting
Montbard, France, 21506
Contact: M DELESCAULT, Dr    33380897220    readapcardio@ch-chatillon-montbard.fr   
Principal Investigator: M DELESCAULT, Dr         
Hopital BROUSSAIS, APHP Recruiting
Paris, France, 75014
Contact: P CRISTOFINI, Dr    33143959234    pascal.cristofini@brs.ap-hop-paris.fr   
Principal Investigator: P CRISTOFINI, Dr         
Sub-Investigator: M C ILIOU, Dr         
Hôpital du haut Lévêque Recruiting
Pessac, France, 33604
Contact: B CATARGI, Dr    33557656565    bogdan.catargi@chu-bordeaux.fr   
Principal Investigator: H DOUARD, Prof         
Sub-Investigator: B CATARGI, Dr         
Rééducation cardiovasculaire CRF Kerpape Recruiting
Ploemeur, France, 56275
Contact: C K KHATTAR, Dr    33297826006    ckhattar@kerpape.mutualite56.fr   
Principal Investigator: C KHATTAR, Dr         
Sub-Investigator: C HUBERT, Dr         
Sub-Investigator: A PASQUIER, Dr         
Sub-Investigator: B SCHMITT, Prof         
Hôpital jeanne d'arc Recruiting
Toul, France, 54201
Contact: J moreira, Dr    33383656528    irr.sectionC@wanadoo.fr   
Principal Investigator: J MOREIRA, Dr         
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, 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: May 6, 2008
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Hypoglycemic Agents
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
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014