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Status unknownNCT00998712Updated Aug 29, 2013

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

An observational study in Gestational Diabetes Mellitus and Pregnancy, sponsored by Brigham and Women's Hospital. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-29.

Sponsored by Brigham and Women's Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
88
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Gestational Diabetes Mellitus
  • Pregnancy

Keywords

  • gestational diabetes mellitus
  • pregnancy
  • cardiovascular disease risk
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's planned enrollment of 88 is below the median of 200 across 269 observational studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Black and white women currently in the thrid trimester of a pregnancy complicated or uncomplicated by gestational diabetes.

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

Exclusion Criteria:

  • History of smoking
  • Are taking potentially vasoactive medications
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
88 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. endothelial function

    Time frame: same day

07

Study locations

1 of 1 sites recruiting
  • Brigham and Women's Hospital, Massachusetts General Hospital
    Boston, Massachusetts 02115, United States
    • Rhonda Bentley-Lewis, MD · Principal investigator
    • Mark Creager, MD · Sub investigator
    • David Nathan, MD · Sub investigator
    • Florence Brown, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00998712
Lead sponsor
Brigham and Women's Hospital
Responsible party
Rhonda Bentley-Lewis, MD (Rhonda Bentley-Lewis, MD, MBA, MMSc, Brigham and Women's Hospital) — Principal investigator
First posted
Oct 20, 2009
Start date
Aug 2009
Primary completion
Oct 2013 (estimated)
Completion
Jan 2014 (estimated)
Last update
Aug 29, 2013

Study contacts

Research Assistant
Contact
RBLResearchGroup@partners.org
617-724-3504
Rhonda Bentley-Lewis, MD, MBA
Contact
rbentleylewis@partners.org
617-726-2874

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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