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

Tracking Information
First Received Date ^ICMJE	May 7, 2008
Last Updated Date	February 1, 2010
Start Date ^ICMJE	January 2004
Primary Completion Date	February 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 7, 2008)	between-group difference in flow-mediated dilation of the brachial artery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00675740 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 7, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Physical Exercise Versus Rosiglitazone in CAD and Prediabetes
Official Title ^ICMJE	Effects of Physical Exercise Versus Rosiglitazone on Endothelial Function in Coronary Artery Disease Patients With Prediabetes
Brief 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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Impaired Glucose Tolerance
Intervention ^ICMJE	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
Study Arm (s)	Experimental: 1 Intervention: Drug: rosiglitazone Active Comparator: 2 physical exercise Intervention: Behavioral: physical exercise No Intervention: 3 control Intervention: Other: control
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	45
Completion Date	February 2007
Primary Completion Date	February 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	35 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00675740
Other Study ID Numbers ^ICMJE	Leipzig 03
Has Data Monitoring Committee	No
Responsible Party	Steffen Desch, University of Leipzig
Study Sponsor ^ICMJE	University of Leipzig
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Leipzig
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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