Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk

This study is currently recruiting participants.

Verified by Brigham and Women's Hospital, June 2008

Sponsored by:	Brigham and Women's Hospital
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00550979

Purpose

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.

Condition
Gestational Diabetes Mellitus Cardiovascular Disease Risk

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk

Further study details as provided by Brigham and Women's Hospital:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	96
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Black women with history of pregnancy/ies complicated by gestational diabetes mellitus
2 Black women with history of normal, uncomplicated pregnancy/ies

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

Healthy self-identified Black female
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
If you are using hormonal therapy such as oral contraceptive pills

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550979

Contacts

Contact: Ffyona V. Patel, BA	617-278-0672	fpatel1@partners.org
Contact: Rhonda Bentley-Lewis, MD	617-525-8444	rbentleylewis@partners.org

Locations

United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Rhonda Bentley-Lewis, MD
Sub-Investigator: Florence Brown, MD
Sub-Investigator: Ellen W. Seely, MD
Sub-Investigator: Edward Horton, MD
Sub-Investigator: Marie Gerhard-Herman, MD
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator:

Rhonda Bentley-Lewis, MD

Brigham and Women's Hospital

More Information

Responsible Party:	Brigham and Women's Hospital ( Rhonda Bentley-Lewis, MD, MBA, MMSc )
Study ID Numbers:	2007P001406
Study First Received:	October 26, 2007
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00550979
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

gestational diabetes mellitus
cardiovascular disease risk

Study placed in the following topic categories:

Pregnancy Complications
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Diabetes, Gestational
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009