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临床试验/NCT00693537
NCT00693537已完成4 期

Long- But Not Short-term Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease

Paracelsus Medical University2 个研究点 分布在 1 个国家开始时间: 2008年6月9日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
试验地点
2

研究概览

简要总结

Patients with type 2 diabetes mellitus suffer from accelerated coronary artery disease. We will assess the effects of exercise training on coronary endothelial function, vascular structure, and inflammation both in serum and skeletal muscle biopsies, as well as expression of diabetes candidate genes.

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • written informed consent
  • preserved left ventricular function (left ventricular ejection fraction ≥ 50%)
  • a physical work capacity ≥ 50 W
  • at least one significant coronary stenosis > 50%, whereas either the left anterior descending (LAD) or circumflex artery (RCX) has to be free from disease or stenoses ≤ 25% for the assessment of intracoronary flow measurements

排除标准

  • diseases further affecting endothelial function
  • untreated hypertension (systolic blood pressure > 160 mm Hg or a diastolic blood pressure of > 90 mm Hg)
  • cigarette smoking during the previous six months
  • LDL-cholesterol > 4.3 mmol/l
  • ventricular tachyarrhythmias
  • chronic obstructive pulmonary disease
  • severe renal or hepatic dysfunction
  • valvular heart disease
  • myocardial infarction within the previous 4 weeks

研究组 & 干预措施

A

Experimental

4 weeks in-hospital exercise training (6x15 min bicycle/day, 5 days/week) followed by a 5 months ambulatory exercise program (30 min ergometer/day, 5 days/week, plus 1h group exercise/week)

干预措施: Exercise training (Behavioral)

B

No Intervention

Control

研究者

发起方
Paracelsus Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Josef Niebauer M.D., Ph.D., MBA

Director of Institute

Paracelsus Medical University

研究点 (2)

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