NCT00675740

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2004

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2008

Completed
Last Updated

February 2, 2010

Status Verified

January 1, 2010

Enrollment Period

3.1 years

First QC Date

May 7, 2008

Last Update Submit

February 1, 2010

Conditions

Impaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

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

    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

    6 months

Study Arms (3)

1

EXPERIMENTAL
Drug: rosiglitazone

2

ACTIVE COMPARATOR

physical exercise

Behavioral: physical exercise

3

NO INTERVENTION

control

Other: control

Interventions

rosiglitazoneDRUG

tablets 4 mg daily

Also known as: Avandia (GlaxoSmithKline)
1
physical exerciseBEHAVIORAL

stationary bike 5-6 times a week

2
controlOTHER

control without intervention

3

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glucose Intolerance

Interventions

RosiglitazonehalofantrineExercise

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 12, 2008

Study Start

January 1, 2004

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

February 2, 2010

Record last verified: 2010-01