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DARE: Diabetes in cArdiac REhabilitation

Primary Purpose

Type 2 Diabetes Mellitus, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Conventional antidiabetic treatment
Intensive insulin treatment
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes mellitus, cardiac rehabilitation, insulin

Eligibility Criteria

25 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre hospitalier du pays d'Aix
  • Clinique Rhône Durance
  • Hôpital J Minjoz
  • CMC Bligny
  • centre de réadaptation cardiaque "Château le moine"
  • CHU du Bocage
  • Centre IRIS
  • Centre Hospitalier de MONTBARD
  • Hopital BROUSSAIS, APHP
  • Hôpital du haut Lévêque
  • Rééducation cardiovasculaire CRF Kerpape
  • Hôpital jeanne d'arc

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

B

A

Arm Description

No intensive treatment

Intensive insulin treatment

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

number of patients, in each group of treatment, having improved from at least 16% their peak VO2, after cardiac rehabilitation.
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).
improvement of ventilatory threshold
Effect of strict glycemic control during cardiac rehabilitation on improvement of ventilatory threshold

Full Information

First Posted
July 19, 2006
Last Updated
November 17, 2014
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT00354237
Brief Title
DARE: Diabetes in cArdiac REhabilitation
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 Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 threshold)in 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Coronary Artery Disease
Keywords
diabetes mellitus, cardiac rehabilitation, insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Other
Arm Description
No intensive treatment
Arm Title
A
Arm Type
Experimental
Arm Description
Intensive insulin treatment
Intervention Type
Other
Intervention Name(s)
Conventional antidiabetic treatment
Intervention Description
No intensive treatment
Intervention Type
Other
Intervention Name(s)
Intensive insulin treatment
Intervention Description
Intensive insulin treatment
Primary Outcome Measure Information:
Title
improvement of peak VO2,
Description
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).
Time Frame
at the beginning and at the end of the cardiac rehabilitation programm
Secondary Outcome Measure Information:
Title
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
Title
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
Title
improvement of ventilatory threshold
Description
Effect of strict glycemic control during cardiac rehabilitation on improvement of ventilatory threshold
Time Frame
from the beginning and at the end of the cardiac rehabilitation programm

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno L Vergès, Prof
Organizational Affiliation
Centre Hospitalier Universitaire Dijon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier du pays d'Aix
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
Facility Name
Clinique Rhône Durance
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Hôpital J Minjoz
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
CMC Bligny
City
Briis Sous Forges
ZIP/Postal Code
91640
Country
France
Facility Name
centre de réadaptation cardiaque "Château le moine"
City
Cenon
ZIP/Postal Code
33150
Country
France
Facility Name
CHU du Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre IRIS
City
Marcy l'Etoile
ZIP/Postal Code
69280
Country
France
Facility Name
Centre Hospitalier de MONTBARD
City
Montbard
ZIP/Postal Code
21506
Country
France
Facility Name
Hopital BROUSSAIS, APHP
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital du haut Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Rééducation cardiovasculaire CRF Kerpape
City
Ploemeur
ZIP/Postal Code
56275
Country
France
Facility Name
Hôpital jeanne d'arc
City
Toul
ZIP/Postal Code
54201
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26152221
Citation
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.
Results Reference
derived

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DARE: Diabetes in cArdiac REhabilitation

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