Text Size

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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Steffen Desch, University of Leipzig
ClinicalTrials.gov Identifier: NCT00675740     History of Changes
Other Study ID Numbers: Leipzig 03
Study First Received: May 7, 2008
Last Updated: February 1, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Coronary Artery Disease
Glucose Intolerance
Prediabetic State
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013