Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354237
Status:
COMPLETED
Last Update Posted:
2014-11-18
First Post:
2006-07-19
Brief Title:
DARE Diabetes in cArdiac REhabilitation
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 thresholdin patients with type 2 diabetes with coronary artery disease
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None