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CompletedNCT00675740Updated Feb 2, 2010

Physical Exercise Versus Rosiglitazone in CAD and Prediabetes

A Phase 4 interventional study of rosiglitazone and physical exercise in Impaired Glucose Tolerance, sponsored by University of Leipzig. Completed. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-02-02.

Sponsored by University of Leipzig · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
35 Years to 70 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Impaired Glucose Tolerance
03

In context

Prediabetic State

999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.

This study's enrollment of 45 is below the median of 65 across 844 interventional studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • impaired fasting glucose or impaired glucose tolerance
  • angiographic evidence of coronary artery disease

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    1

    Drug: rosiglitazone

  • Active comparator
    2

    physical exercise

    Behavioral: physical exercise

  • No intervention
    3

    control

    Other: control

Interventions

  • Drugrosiglitazone

    tablets 4 mg daily

    Also known as: Avandia (GlaxoSmithKline)

  • Behavioralphysical exercise

    stationary bike 5-6 times a week

  • Othercontrol

    control without intervention

06

What researchers measure

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00675740
Lead sponsor
University of Leipzig
First posted
May 12, 2008
Start date
Jan 2004
Primary completion
Feb 2007
Completion
Feb 2007
Last update
Feb 2, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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