Physical Exercise Versus Rosiglitazone in CAD and Prediabetes

Impaired Glucose Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675740
• Other study ID #: Leipzig 03
• Status: Completed
• Phase: Phase 4
• First received: May 7, 2008
• Last updated: February 1, 2010
• Start date: January 2004
• Est. completion date: February 2007

Study information

• Verified date: January 2010
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Drug:
• rosiglitazone
tablets 4 mg daily

Behavioral:
• physical exercise
stationary bike 5-6 times a week

Other:
• control
control without intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	between-group difference in flow-mediated dilation of the brachial artery		6 months	No
Secondary	relative effects of treatment on parameters of - glucose metabolism - inflammatory plasma markers - markers of endothelial function - cellular markers in muscle and fat biopsies		6 months	No