Physical Exercise Versus Rosiglitazone in CAD and Prediabetes
Information source: University of Leipzig
ClinicalTrials.gov processed this data on August 20, 2015 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: Effects of Physical Exercise Versus Rosiglitazone on Endothelial Function in Coronary Artery Disease Patients With Prediabetes
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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
Last updated: February 1, 2010
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