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NCT Number: NCT00354237

DARE: Diabetes in cArdiac REhabilitation

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.

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Key information

Age range

25 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier du pays d'Aix, Aix-en-Provence, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional antidiabetic treatment

Other

No intensive treatment

Intensive insulin treatment

Other

Intensive insulin treatment

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2006
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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