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Physical Exercise Versus Rosiglitazone in CAD and Prediabetes

This study has been completed.
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00675740
First received: May 7, 2008
Last updated: February 1, 2010
Last verified: January 2010

May 7, 2008
February 1, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00675740 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
    control
    Intervention: Other: control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
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
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00675740
Leipzig 03
No
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