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Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Rhonda Bentley-Lewis, MD, Brigham and Women's Hospital.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Massachusetts General Hospital
Joslin Diabetes Center
Information provided by (Responsible Party):
Rhonda Bentley-Lewis, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00550979
First received: October 26, 2007
Last updated: August 28, 2013
Last verified: August 2013
  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
Gestational Diabetes Mellitus

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

Further study details as provided by Rhonda Bentley-Lewis, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • endothelial function [ Time Frame: same day ]

Biospecimen Retention:   Samples With DNA
blood and urine

Estimated Enrollment: 96
Study Start Date: September 2007
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (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   (Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Research Assistant 617-724-3504 RBLResearchGroup@partners.org
Contact: Rhonda Bentley-Lewis, MD, MBA 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
Massachusetts General Hospital
Joslin Diabetes Center
Investigators
Principal Investigator: Rhonda Bentley-Lewis, MD Brigham and Women's Hospital
  More Information

Responsible Party: Rhonda Bentley-Lewis, MD, Rhonda Bentley-Lewis, MD, MBA, MMSc, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00550979     History of Changes
Other Study ID Numbers: 2007P001406
Study First Received: October 26, 2007
Last Updated: August 28, 2013

Keywords provided by Rhonda Bentley-Lewis, MD, Brigham and Women's Hospital:
gestational diabetes mellitus
cardiovascular disease risk
heart disease risk

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on June 26, 2017