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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Other | No intensive treatment |
|
| A | Experimental | Intensive insulin treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional antidiabetic treatment | Other | No intensive treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| improvement of peak VO2, | 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). | at the beginning and at the end of the cardiac rehabilitation programm |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients, in each group of treatment, having improved from at least 16% their peak VO2, after cardiac rehabilitation. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno L Vergès, Prof | Centre Hospitalier Universitaire Dijon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier du pays d'Aix | Aix-en-Provence | 13616 | France | |||
| Clinique Rhône Durance |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26152221 | Derived | Verges B, Patois-Verges B, Iliou MC, Simoneau-Robin I, Bertrand JH, Feige JM, Douard H, Catargi B, Fischbach M; DARE Study group. Influence of glycemic control on gain in VO2 peak, in patients with type 2 diabetes enrolled in cardiac rehabilitation after an acute coronary syndrome. The prospective DARE study. BMC Cardiovasc Disord. 2015 Jul 8;15:64. doi: 10.1186/s12872-015-0055-8. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Intensive insulin treatment |
| Other |
Intensive insulin treatment |
|
| at the beginning and at the end of the cardiac rehabilitation programm |
| improvement of ventilatory threshold | Effect of strict glycemic control during cardiac rehabilitation on improvement of ventilatory threshold | from the beginning and at the end of the cardiac rehabilitation programm |
| Avignon |
| 84082 |
| France |
| Hôpital J Minjoz | Besançon | 25000 | France |
| CMC Bligny | Briis-sous-Forges | 91640 | France |
| centre de réadaptation cardiaque "Château le moine" | Cenon | 33150 | France |
| CHU du Bocage | Dijon | 21079 | France |
| Centre IRIS | Marcy-l'Étoile | 69280 | France |
| Centre Hospitalier de MONTBARD | Montbard | 21506 | France |
| Hopital BROUSSAIS, APHP | Paris | 75014 | France |
| Hôpital du haut Lévêque | Pessac | 33604 | France |
| Rééducation cardiovasculaire CRF Kerpape | Ploemeur | 56275 | France |
| Hôpital jeanne d'arc | Toul | 54201 | France |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006946 | Hyperinsulinism |