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Physical Exercise Versus Rosiglitazone in CAD and Prediabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00675740
First Posted: May 12, 2008
Last Update Posted: February 2, 2010
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.
Information provided by:
University of Leipzig
  Purpose
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).

Condition Intervention Phase
Impaired Glucose Tolerance Drug: rosiglitazone Behavioral: physical exercise Other: control Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Physical Exercise Versus Rosiglitazone on Endothelial Function in Coronary Artery Disease Patients With Prediabetes

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • between-group difference in flow-mediated dilation of the brachial artery [ Time Frame: 6 months ]

Secondary Outcome 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 ]

Enrollment: 45
Study Start Date: January 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rosiglitazone
tablets 4 mg daily
Other Name: Avandia (GlaxoSmithKline)
Active Comparator: 2
physical exercise
Behavioral: physical exercise
stationary bike 5-6 times a week
No Intervention: 3
control
Other: control
control without intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Steffen Desch, University of Leipzig
ClinicalTrials.gov Identifier: NCT00675740     History of Changes
Other Study ID Numbers: Leipzig 03
First Submitted: May 7, 2008
First Posted: May 12, 2008
Last Update Posted: February 2, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs