DARE: Diabetes in cArdiac REhabilitation

Centre Hospitalier Universitaire Dijon60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus Coronary Artery Disease

Interventions

Conventional antidiabetic treatmentOTHER

No intensive treatment

Intensive insulin treatmentOTHER

Intensive insulin treatment

Eligibility

Sex: ALLMin age: 25 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (12)

Centre hospitalier du pays d'Aix

Aix-en-Provence, France

Clinique Rhône Durance

Avignon, France

Hôpital J Minjoz

Besançon, France

Outcomes

Primary Outcomes

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).

Time frame: at the beginning and at the end of the cardiac rehabilitation programm

Secondary Outcomes

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

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

improvement of ventilatory threshold

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.