Clincosm LogoSign in Get a demo

C-reactive Protein and Endothelial Dysfunction in Women With Glucose Intolerance

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT00589355
Collaborator
(none)
46
Enrollment
1
Location
81
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to determine whether markers of vascular inflammation (such as c-reactive protein) can predict endothelial dysfunction (as measured by flow-mediated dilation) in postmenopausal women with glucose intolerance compared to normal controls.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    46 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    C-reactive Protein and Endothelial Dysfunction in Women With Glucose Intolerance
    Study Start Date :
    Jan 1, 2002
    Actual Primary Completion Date :
    Jun 1, 2003
    Actual Study Completion Date :
    Oct 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    1

    postmenopausal women with glucose intolerance (either pre-diabetes or diet-controlled diabetes)
    2

    postmenopausal women with normal glucose tolerance

    Outcome Measures

    Primary Outcome Measures

    1. c-reactive protein [performed after screening evaluation]

    Secondary Outcome Measures

    1. flow-mediated dilation of brachial artery [performed twice after screening visit]

    2. sex steroids [performed after screening visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • healthy postmenopausal women

    • ages 40-65

    Exclusion Criteria:

    • smokers

    • diabetes requiring medication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale Center for Clinical Investigation New Haven Connecticut United States 06520

    Sponsors and Collaborators

    • Yale University

    Investigators

    • Principal Investigator: Barbara I Gulanski, MD, MPH, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00589355
    Other Study ID Numbers:
    • 12110
    First Posted:
    Jan 9, 2008
    Last Update Posted:
    Apr 17, 2020
    Last Verified:
    Apr 1, 2020
    Keywords provided by , ,
    c-reactive protein
    endothelial dysfunction
    glucose intolerance
    Additional relevant MeSH terms:
    Glucose Intolerance

    Study Results

    No Results Posted as of Apr 17, 2020