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临床试验/NCT00354237
NCT00354237已完成不适用

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.

Centre Hospitalier Universitaire Dijon24 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2005年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
24
主要终点
improvement of peak VO2,

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes mellitus
  • recent Miocardial Infarction
  • HbA1c above 7%
  • enrolled in a cardiac rehabilitation program

排除标准

  • Type 1 diabetes
  • Coronary Bypass Surgery
  • Renal Failure (creatinine clearance below 30 ml/min)
  • severe Respiratory Failure

结局指标

主要结局

improvement of peak VO2,

时间窗: 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).

次要结局

  • number of patients, in each group of treatment, having improved from at least 16% their peak VO2, after cardiac rehabilitation.(at the beginning and at the end of the cardiac rehabilitation programm)
  • improvement of ventilatory threshold(from 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).(at the beginning and at the end of the cardiac rehabilitation programm)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Bruno Vergès

Professor

Centre Hospitalier Universitaire Dijon

研究点 (24)

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