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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00693537
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University

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 Behavioral: Exercise training Phase 4

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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

Resource links provided by the National Library of Medicine


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)
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




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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
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

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
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Austria
University Institute of Sports Medicine, Prevention and Rehabilitation
Salzburg, Austria, 5020
Sponsors and Collaborators
Paracelsus Medical University
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Responsible Party: Prof. Josef Niebauer M.D., Ph.D., MBA, Director of Institute, Paracelsus Medical University
ClinicalTrials.gov Identifier: NCT00693537    
Other Study ID Numbers: UISM-2-2008
First Posted: June 9, 2008    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: June 2008
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases