Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2005-07-31
2012-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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B
No intensive treatment
Conventional antidiabetic treatment
No intensive treatment
A
Intensive insulin treatment
Intensive insulin treatment
Intensive insulin treatment
Interventions
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Conventional antidiabetic treatment
No intensive treatment
Intensive insulin treatment
Intensive insulin treatment
Eligibility Criteria
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Inclusion Criteria
* recent Miocardial Infarction
* HbA1c above 7%
* enrolled in a cardiac rehabilitation program
Exclusion Criteria
* Coronary Bypass Surgery
* Renal Failure (creatinine clearance below 30 ml/min)
* severe Respiratory Failure
25 Years
95 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Prof. Bruno Vergès
Professor
Principal Investigators
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Bruno L Vergès, Prof
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire Dijon
Locations
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Centre hospitalier du pays d'Aix
Aix-en-Provence, , France
Clinique Rhône Durance
Avignon, , France
Hôpital J Minjoz
Besançon, , France
CMC Bligny
Briis-sous-Forges, , France
centre de réadaptation cardiaque "Château le moine"
Cenon, , France
CHU du Bocage
Dijon, , France
Centre IRIS
Marcy-l'Étoile, , France
Centre Hospitalier de MONTBARD
Montbard, , France
Hopital BROUSSAIS, APHP
Paris, , France
Hôpital du haut Lévêque
Pessac, , France
Rééducation cardiovasculaire CRF Kerpape
Ploemeur, , France
Hôpital jeanne d'arc
Toul, , France
Countries
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References
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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.
Other Identifiers
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DGS2005/0130
Identifier Type: -
Identifier Source: org_study_id