DARE: Diabetes in cArdiac REhabilitation
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| ClinicalTrials.gov Identifier: NCT00354237 |
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Recruitment Status
:
Completed
First Posted
: July 20, 2006
Last Update Posted
: November 18, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 2 Diabetes Mellitus Coronary Artery Disease | Other: Conventional antidiabetic treatment Other: Intensive insulin treatment | Not Applicable |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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B
No intensive treatment
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Other: Conventional antidiabetic treatment
No intensive treatment
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Experimental: A
Intensive insulin treatment
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Other: Intensive insulin treatment
Intensive insulin treatment
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- 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).
- 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
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| Ages Eligible for Study: | 25 Years to 95 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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
| 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 | |
| Principal Investigator: | Bruno L Vergès, Prof | Centre Hospitalier Universitaire Dijon |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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diabetes mellitus cardiac rehabilitation insulin |
Additional relevant MeSH terms:
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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 |