Physical Exercise Versus Rosiglitazone in CAD and 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).

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Key information

Conditions

Impaired Glucose Tolerance Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rosiglitazone

Drug

tablets 4 mg daily

Other names: Avandia (GlaxoSmithKline)

Physical exercise

Behavioral

stationary bike 5-6 times a week

Control

Other

control without intervention

Primary outcomes

between-group difference in flow-mediated dilation of the brachial artery

Time frame: 6 months

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

Effects of Physical Exercise Versus Rosiglitazone on Endothelial Function in Coronary Artery Disease Patients With Prediabetes

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2007
First posted: May 12, 2008
Registry last updated: Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed