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Physical Exercise Versus Rosiglitazone in CAD and Prediabetes

Primary Purpose

Impaired Glucose Tolerance

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
rosiglitazone
physical exercise
control
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impaired Glucose Tolerance

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    1

    2

    3

    Arm Description

    physical exercise

    control

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    relative effects of treatment on parameters of - glucose metabolism - inflammatory plasma markers - markers of endothelial function - cellular markers in muscle and fat biopsies

    Full Information

    First Posted
    May 7, 2008
    Last Updated
    February 1, 2010
    Sponsor
    University of Leipzig
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00675740
    Brief Title
    Physical Exercise Versus Rosiglitazone in CAD and Prediabetes
    Official Title
    Effects of Physical Exercise Versus Rosiglitazone on Endothelial Function in Coronary Artery Disease Patients With Prediabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    February 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Leipzig

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Impaired Glucose Tolerance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    physical exercise
    Arm Title
    3
    Arm Type
    No Intervention
    Arm Description
    control
    Intervention Type
    Drug
    Intervention Name(s)
    rosiglitazone
    Other Intervention Name(s)
    Avandia (GlaxoSmithKline)
    Intervention Description
    tablets 4 mg daily
    Intervention Type
    Behavioral
    Intervention Name(s)
    physical exercise
    Intervention Description
    stationary bike 5-6 times a week
    Intervention Type
    Other
    Intervention Name(s)
    control
    Intervention Description
    control without intervention
    Primary Outcome Measure Information:
    Title
    between-group difference in flow-mediated dilation of the brachial artery
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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