Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk

This study is currently recruiting participants.

Verified November 2010 by Brigham and Women's Hospital

First Received on October 26, 2007. Last Updated on November 1, 2010 History of Changes

Sponsor:	Brigham and Women's Hospital
Collaborator:	Joslin Diabetes Center
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
Healthy Normotensive Gestational Diabetes Mellitus Cardiovascular Disease

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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

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

Estimated Enrollment:	96
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (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
3 White women with a history of pregnancy/ies complicated by gestational diabetes.
4 White women with a 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 and white women who have had uncomplicated pregnancies or pregnancies complicated by gestational diabetes in the past 5 years

Criteria

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

Contacts and Locations

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

Contacts

Contact: Kaitlyn Barnes, BA	617-724-3504	RBLResearchGroup@partners.org
Contact: Rhonda Bentley-Lewis, MD	617-726-2874	rbentleylewis@partners.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
Sub-Investigator: Florence Brown, MD
Sub-Investigator: David Nathan, MD
Sub-Investigator: Mark Creager, MD
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

Joslin Diabetes Center

Investigators

Principal Investigator:

Rhonda Bentley-Lewis, MD

Brigham and Women's Hospital

More Information

No publications provided

Responsible Party:	Rhonda Bentley-Lewis, MD, MBA, MMSc, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00550979 History of Changes
Other Study ID Numbers:	2007P001406
Study First Received:	October 26, 2007
Last Updated:	November 1, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

gestational diabetes mellitus
cardiovascular disease risk
heart disease risk

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 24, 2012