Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by:
Paracelsus Medical University
ClinicalTrials.gov Identifier:
NCT00693537
First received: June 4, 2008
Last updated: June 6, 2008
Last verified: June 2008

June 4, 2008
June 6, 2008
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Complete list of historical versions of study NCT00693537 on ClinicalTrials.gov Archive Site
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Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease
Long- But Not Short-Term Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease

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.

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Interventional
Phase 4
Allocation: Randomized
  • Type 2 Diabetes Mellitus
  • Coronary Artery Disease
  • Procedure: Coronary angiography
    At baseline, 4 weeks, and 6 months changes in diameter of coronary arteries in response to intracoronary infusion of acetylcholine were analyzed by quantitative coronary angiography, mean peak flow velocity by Doppler velocimetry, and intramural plaques by intravascular ultrasound.
  • Behavioral: Exercise training
    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)
  • Experimental: A
    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)
    Interventions:
    • Procedure: Coronary angiography
    • Behavioral: Exercise training
  • No Intervention: B
    Control
    Intervention: Procedure: Coronary angiography
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00693537
UISM-2-2008
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Paracelsus Medical University
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Paracelsus Medical University
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP