Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT00998712

Conditions

Gestational Diabetes Mellitus

Pregnancy

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 between black women and white women who have or do not have gestational diabetes mellitus.

Conditions

Gestational Diabetes Mellitus

Pregnancy

Study ID

NCT00998712

Start date

Aug, 2009

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,
  • 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

Study Design

Enrollment

88 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 29, 2013

Last verified

Aug, 2013

Keywords

  • gestational diabetes mellitus
  • pregnancy
  • cardiovascular 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.