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

This study is currently recruiting participants.
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

October 16, 2009
August 28, 2013
August 2009
October 2013   (final data collection date for primary outcome measure)
endothelial function [ Time Frame: same day ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00998712 on ClinicalTrials.gov Archive Site
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Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction
Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

blood and urine samples

Non-Probability Sample

Black and white women currently in the thrid trimester of a pregnancy complicated or uncomplicated by gestational diabetes.

  • Gestational Diabetes Mellitus
  • Pregnancy
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
88
January 2014
October 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
Yes
Contact: Research Assistant 617-724-3504 RBLResearchGroup@partners.org
Contact: Rhonda Bentley-Lewis, MD, MBA 617-726-2874 rbentleylewis@partners.org
United States
 
NCT00998712
2009P001255
No
Rhonda Bentley-Lewis, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
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Not Provided
Brigham and Women's Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP