- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00693537
Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease
August 29, 2019 updated by: Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Salzburg, Austria, 5020
- University Institute of Sports Medicine, Prevention and Rehabilitation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
Arms and Interventions
Participant Group / 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)
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 4, 2008
First Submitted That Met QC Criteria
June 6, 2008
First Posted (Estimate)
June 9, 2008
Study Record Updates
Last Update Posted (Actual)
August 30, 2019
Last Update Submitted That Met QC Criteria
August 29, 2019
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UISM-2-2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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