Physical Exercise Versus Rosiglitazone in CAD and Prediabetes

NCT ID: NCT00675740

Last Updated: 2010-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-02-28

Brief Summary

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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

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Conditions

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Impaired Glucose Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

rosiglitazone

Intervention Type DRUG

tablets 4 mg daily

2

physical exercise

Group Type ACTIVE_COMPARATOR

physical exercise

Intervention Type BEHAVIORAL

stationary bike 5-6 times a week

3

control

Group Type NO_INTERVENTION

control

Intervention Type OTHER

control without intervention

Interventions

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rosiglitazone

tablets 4 mg daily

Intervention Type DRUG

physical exercise

stationary bike 5-6 times a week

Intervention Type BEHAVIORAL

control

control without intervention

Intervention Type OTHER

Other Intervention Names

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Avandia (GlaxoSmithKline)

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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University of Leipzig

Other Identifiers

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Leipzig 03

Identifier Type: -

Identifier Source: org_study_id

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