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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2010 by Brigham and Women's Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT00998712

First received: October 16, 2009

Last updated: November 1, 2010

Last verified: November 2010

History of Changes

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

Condition
Gestational Diabetes Vascular Function Cardiovascular Disease

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

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

Biospecimen Retention: Samples With DNA

blood and urine samples

Estimated Enrollment:	88
Study Start Date:	August 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Groups/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.

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998712

Contacts

Contact: Kaitlyn Barnes, BA	617-724-3504	RBLResearchGroup@partners.org
Contact: Rhonda Bentley-Lewis, MD, MBA, MMSc	617-726-2874	rbentleylewis@partner.org

Locations

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

Sponsors and Collaborators

Brigham and Women's Hospital

More Information

No publications provided

Responsible Party:	Rhonda Bentley-Lewis, MD, MBA, MMSc, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00998712 History of Changes
Other Study ID Numbers:	2009P001255
Study First Received:	October 16, 2009
Last Updated:	November 1, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

gestational diabetes
pregnancy
cardiovascular disease risk
vascular function

Additional relevant MeSH terms:

Cardiovascular Diseases
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders

Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on May 21, 2013

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