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

August 28, 2013 updated by: Rhonda Bentley-Lewis, MD, Brigham and Women's Hospital
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital, Massachusetts General Hospital
        • Principal Investigator:
          • Rhonda Bentley-Lewis, MD
        • Sub-Investigator:
          • Florence Brown, MD
        • Sub-Investigator:
          • David Nathan, MD
        • Sub-Investigator:
          • Mark Creager, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
endothelial function
Time Frame: same day
same day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

October 16, 2009

First Submitted That Met QC Criteria

October 19, 2009

First Posted (Estimate)

October 20, 2009

Study Record Updates

Last Update Posted (Estimate)

August 29, 2013

Last Update Submitted That Met QC Criteria

August 28, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009P001255

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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