Relative Effects of Physical Exercise Versus Rosiglitazone on Endothelial Function in Coronary Artery Disease (CAD) Patients With Impaired Fasting Glucose or Impaired Glucose Tolerance
Information source: University of Leipzig
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Impaired Glucose Tolerance
Intervention: rosiglitazone (Drug); physical exercise (Behavioral); control (Other)
Phase: Phase 4
Status: Completed
Sponsored by: University of Leipzig
Summary
The aim of this study is to prospectively assess the relative benefits of either treatment
with rosiglitazone or physical exercise on endothelial function in patients with impaired
fasting glucose or impaired glucose tolerance and coronary artery disease (CAD).
Clinical Details
Official title: Relative Effects of Physical Exercise vs. Rosiglitazone on Endothelial Function in CAD Patients With Impaired Fasting Glucose or Impaired Glucose Tolerance
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: between-group difference in flow-mediated dilation of the brachial artery
Secondary outcome: relative effects of treatment on parameters of
- glucose metabolism
- inflammatory plasma markers
- markers of endothelial function
- cellular markers in muscle and fat biopsies
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- impaired fasting glucose or impaired glucose tolerance
- angiographic evidence of coronary artery disease
Exclusion Criteria:
- diabetes mellitus type I or II
- preexisting antidiabetic medication
- unstable angina
- indication for coronary bypass surgery
- significant left main disease
- myocardial infarction within preceding 3 months
- ejection fraction < 40%
- significant heart valve disease
- severe metabolic disorders
- severe disorders in lipoprotein metabolism
- thyroid disorders
- alcohol or drug abuse
- pregnancy
- participation in another trial
Locations and Contacts
Additional Information
Starting date: January 2004
Ending date: February 2007
Last updated: May 7, 2008
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