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Physical Exercise Versus Rosiglitazone in CAD and Prediabetes

Information source: University of Leipzig
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Impaired Glucose Tolerance

Intervention: rosiglitazone (Drug); physical exercise (Behavioral); control (Other)

Phase: Phase 4

Status: Completed

Sponsored by: University of Leipzig

Summary

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome: relative effects of treatment on parameters of - glucose metabolism - inflammatory plasma markers - markers of endothelial function - cellular markers in muscle and fat biopsies

Eligibility

Minimum age: 35 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: January 2004
Last updated: February 1, 2010

Page last updated: August 20, 2015

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