Official Title: “Relative Effects of Physical Exercise vs. Rosiglitazone on Endothelial Function in CAD Patients With Impaired Fasting Glucose or Impaired Glucose Tolerance”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2007

Intervention(s) in this Clinical Trial

• Drug: rosiglitazone
  • tablets 4 mg daily
• Behavioral: physical exercise
  • stationary bike 5-6 times a week
• Other: control
  • control without intervention

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2
  • physical exercise
• No Intervention: 3
  • control

Primary Measures

• between-group difference in flow-mediated dilation of the brachial artery
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• relative effects of treatment on parameters of - glucose metabolism - inflammatory plasma markers - markers of endothelial function - cellular markers in muscle and fat biopsies
  • Time Frame: 6 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Leipzig

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00675740

Study ID Number: Leipzig 03

ClinicalTrials.gov Identifier: NCT00675740

Health Authority: Germany: Federal Institute for Drugs and Medical Devices