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NCT00998712 Clinical Trial

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

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00998712
Other study ID # 2009P001255
Secondary ID
Status Recruiting
Phase N/A
First received October 16, 2009
Last updated August 28, 2013
Start date August 2009
Est. completion date January 2014

Study information
Verified date August 2013
Source Brigham and Women's Hospital
Contact Research Assistant
Phone 617-724-3504
Email RBLResearchGroup@partners.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 88
Est. completion date January 2014
Est. primary completion date October 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Brigham and Women's Hospital, Massachusetts General Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary endothelial function same day No
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