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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Rhonda Bentley-Lewis, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00998712
First received: October 16, 2009
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 between black women and white women who have or do not have gestational diabetes mellitus.


Condition
Gestational Diabetes Mellitus
Pregnancy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • endothelial function [ Time Frame: same day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood and urine samples


Estimated Enrollment: 88
Study Start Date: August 2009
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 in the third trimester of a pregnancy complicated by gestational diabetes.
2
Black women in the third trimester of a normal, uncomplicated pregnancy.
3
White women in the third trimester of a pregnancy complicated by gestational diabetes.
4
White women in the third trimester of a normal, uncomplicated pregnancy.

  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 currently in the thrid trimester of a pregnancy complicated or uncomplicated by gestational diabetes.

Criteria

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
  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: NCT00998712

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: Mark Creager, MD         
Sub-Investigator: David Nathan, MD         
Sub-Investigator: Florence Brown, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Rhonda Bentley-Lewis, MD, Rhonda Bentley-Lewis, MD, MBA, MMSc, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00998712     History of Changes
Other Study ID Numbers: 2009P001255
Study First Received: October 16, 2009
Last Updated: August 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
gestational diabetes mellitus
pregnancy
cardiovascular 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 August 28, 2014