DARE: Diabetes in cArdiac REhabilitation
Recruitment status was Recruiting
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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. |
- 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 ]
- 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 |
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| Contact: Bruno L Vergès, Prof., MD | 33 380293453 | bruno.verges@chu-dijon.fr |
| 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 | |
| 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 May 16, 2013