Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT00550979

Conditions

Gestational Diabetes Mellitus

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Study Details

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 in women who have had a pregnancy complicated by diabetes as compared with women who have had a normal pregnancy.

Conditions

Gestational Diabetes Mellitus

Study ID

NCT00550979

Start date

Sep, 2007

Status verified date

Aug, 2013

Completion date

Jan, 2014

Anticipated

Primary completion date

Oct, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy women of self-identified African descent (black) and European (white) ancestry
  • 18-40 years of age
  • Regular menstrual cycles
  • 5 or less years postpartum
  • Have either a normal or a GDM index pregnancy history
  • Are in good health free of thyroid, cardiac, or renal disease

Exclusion Criteria:

  • If you are pregnant
  • If you are lactating

Study Design

Enrollment

96 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Black women with history of pregnancy/ies complicated by gestational diabetes mellitus

2

Black women with history of normal, uncomplicated pregnancy/ies

3

White women with a history of pregnancy/ies complicated by gestational diabetes.

4

White women with a history of normal, uncomplicated pregnancy/ies.

Primary outcome measure

  • endothelial function [ Time Frame: same day ]

Central Contacts and Locations

Central contacts

Research Assistant

617-724-3504RBLResearchGroup@partners.org

Rhonda Bentley-Lewis, MD, MBA

617-726-2874rbentleylewis@partners.org

Locations

Brigham and Women's Hospital, Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Rhonda Bentley-Lewis, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 29, 2013

Last verified

Aug, 2013

Keywords

  • gestational diabetes mellitus
  • cardiovascular disease risk
  • heart disease risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2013-08-29.