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NCT00550979 Clinical Trial

Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk

Gestational Diabetes Mellitus Clinical Trial

Official title:
Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00550979
Other study ID # 2007P001406
Secondary ID
Status Recruiting
Phase N/A
First received October 26, 2007
Last updated August 28, 2013
Start date September 2007
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 in women who have had a pregnancy complicated by diabetes as compared with women who have had a normal pregnancy.

Recruitment information / eligibility
Status Recruiting
Enrollment 96
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

- 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

Sponsors (3)
Lead Sponsor Collaborator
Brigham and Women's Hospital Joslin Diabetes Center, Massachusetts General 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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