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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Coronary Artery Disease
 Procedure: Coronary angiography
Behavioral: Exercise training
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Official Title: Long- But Not Short-Term Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Paracelsus Medical University:

Arms Assigned Interventions
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)
 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)
No Intervention: B
Control
 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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693537

Locations
Austria
University Institute of Sports Medicine, Prevention and Rehabilitation
Salzburg, Austria, 5020
Sponsors and Collaborators
Paracelsus Medical University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00693537     History of Changes
Other Study ID Numbers: UISM-2-2008
Study First Received: June 4, 2008
Last Updated: June 6, 2008
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013