Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

96

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
      • 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

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Black and white women who have had uncomplicated pregnancies or pregnancies complicated by gestational diabetes in the past 5 years

Description

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 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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

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

Collaborators

Massachusetts General Hospital
Joslin Diabetes Center

Investigators

  • Principal Investigator: Rhonda Bentley-Lewis, MD, 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

September 1, 2007

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

October 26, 2007

First Submitted That Met QC Criteria

October 26, 2007

First Posted (Estimate)

October 30, 2007

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

  • 2007P001406

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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