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Physical Exercise Versus Rosiglitazone in CAD and Prediabetes

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. Identifier: NCT00675740
Recruitment Status : Completed
First Posted : May 12, 2008
Last Update Posted : February 2, 2010
Information provided by:
University of Leipzig

May 7, 2008
May 12, 2008
February 2, 2010
January 2004
February 2007   (Final data collection date for primary outcome measure)
between-group difference in flow-mediated dilation of the brachial artery [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00675740 on Archive Site
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 ]
Same as current
Not Provided
Not Provided
Physical Exercise Versus Rosiglitazone in CAD and Prediabetes
Effects of Physical Exercise Versus Rosiglitazone on Endothelial Function in Coronary Artery Disease Patients With Prediabetes
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).
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Impaired Glucose Tolerance
  • Drug: rosiglitazone
    tablets 4 mg daily
    Other Name: Avandia (GlaxoSmithKline)
  • Behavioral: physical exercise
    stationary bike 5-6 times a week
  • Other: control
    control without intervention
  • Experimental: 1
    Intervention: Drug: rosiglitazone
  • Active Comparator: 2
    physical exercise
    Intervention: Behavioral: physical exercise
  • No Intervention: 3
    Intervention: Other: control
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2007
February 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
35 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Leipzig 03
Not Provided
Not Provided
Steffen Desch, University of Leipzig
University of Leipzig
Not Provided
Not Provided
University of Leipzig
January 2010

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