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Trial record 10 of 6528 for:    Open Studies | "Cardiovascular Diseases"
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Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk

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:
Collaborator:
Joslin Diabetes Center
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00550979
First received: October 26, 2007
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 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:

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 19, 2013