DARE: Diabetes in cArdiac REhabilitation

November 17, 2014 updated by: Prof. Bruno Vergès, Centre Hospitalier Universitaire Dijon

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix en Provence, France, 13616
        • Centre Hospitalier du Pays d'Aix
      • Avignon, France, 84082
        • Clinique Rhône Durance
      • Besancon, France, 25000
        • Hôpital J Minjoz
      • Briis Sous Forges, France, 91640
        • CMC Bligny
      • Cenon, France, 33150
        • centre de réadaptation cardiaque "Château le moine"
      • Dijon, France, 21079
        • Chu Du Bocage
      • Marcy l'Etoile, France, 69280
        • Centre IRIS
      • Montbard, France, 21506
        • Centre Hospitalier de MONTBARD
      • Paris, France, 75014
        • Hopital BROUSSAIS, APHP
      • Pessac, France, 33604
        • Hôpital du Haut Lévêque
      • Ploemeur, France, 56275
        • Rééducation cardiovasculaire CRF Kerpape
      • Toul, France, 54201
        • Hôpital Jeanne d'Arc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: B
No intensive treatment
Other: Conventional antidiabetic treatment
No intensive treatment
Experimental: A
Intensive insulin treatment
Other: Intensive insulin treatment
Intensive insulin treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at the beginning and at the end of the cardiac rehabilitation programm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
from the beginning and at the end of the cardiac rehabilitation programm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Investigators

  • Principal Investigator: Bruno L Vergès, Prof, Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 19, 2006

First Submitted That Met QC Criteria

July 19, 2006

First Posted (Estimate)

July 20, 2006

Study Record Updates

Last Update Posted (Estimate)

November 18, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGS2005/0130

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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