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Sponsored by: |
Centre Hospitalier Universitaire Dijon |
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Information provided by: | Centre Hospitalier Universitaire Dijon |
ClinicalTrials.gov Identifier: | NCT00354237 |
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 |
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Type 2 Diabetes Mellitus Coronary Artery Disease |
Other: Conventional antidiabetic treatment Other: Intensive insulin treatment |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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. |
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 |
---|---|
B: No Intervention
Usual antidiabetic treatment
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Other: Conventional antidiabetic treatment
Usual antidiabetic treatment
|
A: Experimental
Intensive insulin treatment
|
Other: Intensive insulin treatment
Intensive insulin treatment
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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.
Ages Eligible for Study: | 25 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bruno L Vergès, Prof., MD | 33 380293453 | bruno.verges@chu-dijon.fr |
France | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | University Hospital dijon |
Responsible Party: | Centre Hospitalier Universitaire Dijon ( Prof. Bruno Vergès ) |
Study ID Numbers: | DGS2005/0130 |
Study First Received: | July 19, 2006 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00354237 |
Health Authority: | France: Ministry of Health |
diabetes mellitus cardiac rehabilitation insulin |
Arterial Occlusive Diseases Heart Diseases Metabolic Diseases Myocardial Ischemia Diabetes Mellitus Vascular Diseases Endocrine System Diseases Ischemia |
Arteriosclerosis Insulin Coronary Disease Diabetes Mellitus, Type 2 Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Coronary Artery Disease |
Hypoglycemic Agents Physiological Effects of Drugs Cardiovascular Diseases Pharmacologic Actions |