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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

Tracking Information
First Submitted Date  ICMJE June 4, 2008
First Posted Date  ICMJE June 9, 2008
Last Update Posted Date August 30, 2019
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease
Official Title  ICMJE Long- But Not Short-term Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Coronary Artery Disease
Intervention  ICMJE 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)
Study Arms  ICMJE
  • 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)
    Intervention: Behavioral: Exercise training
  • No Intervention: B
    Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00693537
Other Study ID Numbers  ICMJE UISM-2-2008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University
Study Sponsor  ICMJE Paracelsus Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Paracelsus Medical University
Verification Date June 2008

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