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

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ClinicalTrials.gov Identifier: NCT00693537
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : June 9, 2008
Sponsor:
Information provided by:
Paracelsus Medical University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Coronary Artery Disease Procedure: Coronary angiography Behavioral: Exercise training Phase 4

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

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693537


Locations
Austria
University Institute of Sports Medicine, Prevention and Rehabilitation
Salzburg, Austria, 5020
Sponsors and Collaborators
Paracelsus Medical University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00693537     History of Changes
Other Study ID Numbers: UISM-2-2008
First Posted: June 9, 2008    Key Record Dates
Last Update Posted: June 9, 2008
Last Verified: June 2008

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