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Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00998712
Collaborator
(none)
88
Enrollment
1
Location
53
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to look at whether there are differences in blood vessel function, risk for developing diabetes (high blood sugar), lipid (blood fat) levels, and levels of other blood markers between black women and white women who have or do not have gestational diabetes mellitus.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    88 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction
    Study Start Date :
    Aug 1, 2009
    Anticipated Primary Completion Date :
    Oct 1, 2013
    Anticipated Study Completion Date :
    Jan 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Black women in the third trimester of a pregnancy complicated by gestational diabetes.
    2

    Black women in the third trimester of a normal, uncomplicated pregnancy.
    3

    White women in the third trimester of a pregnancy complicated by gestational diabetes.
    4

    White women in the third trimester of a normal, uncomplicated pregnancy.

    Outcome Measures

    Primary Outcome Measures

    1. endothelial function [same day]

    Eligibility Criteria

    Criteria

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

    • Healthy women of self-identified African descent (black) and European (white) ancestry,

    • 18-40 years of age,

    • Body mass index < 35 kg/m2

    • History of regular menstrual cycles,

    • Are currently pregnant and in third trimester of pregnancy (after 24 weeks gestational age)

    • Have no pregnancy-associated complications to-date

    • Are in good health free of hypertension, as well as thyroid, cardiac, or renal disease.

    Exclusion Criteria:

    • History of smoking

    • Are taking potentially vasoactive medications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital, Massachusetts General Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Brigham and Women's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rhonda Bentley-Lewis, MD, Rhonda Bentley-Lewis, MD, MBA, MMSc, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT00998712
    Other Study ID Numbers:
    • 2009P001255
    First Posted:
    Oct 20, 2009
    Last Update Posted:
    Aug 29, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Rhonda Bentley-Lewis, MD, Rhonda Bentley-Lewis, MD, MBA, MMSc, Brigham and Women's Hospital
    gestational diabetes mellitus
    pregnancy
    cardiovascular disease risk
    Additional relevant MeSH terms:
    Diabetes, Gestational
    Cardiovascular Diseases
    Diabetes Mellitus

    Study Results

    No Results Posted as of Aug 29, 2013