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

NCT ID: NCT00998712

Last Updated: 2013-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gestational Diabetes Mellitus Pregnancy

Keywords

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gestational diabetes mellitus pregnancy cardiovascular disease risk

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Black women in the third trimester of a pregnancy complicated by gestational diabetes.

No interventions assigned to this group

2

Black women in the third trimester of a normal, uncomplicated pregnancy.

No interventions assigned to this group

3

White women in the third trimester of a pregnancy complicated by gestational diabetes.

No interventions assigned to this group

4

White women in the third trimester of a normal, uncomplicated pregnancy.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rhonda Bentley-Lewis, MD

Rhonda Bentley-Lewis, MD, MBA, MMSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Hospital, Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Research Assistant

Role: CONTACT

Phone: 617-724-3504

Email: [email protected]

Rhonda Bentley-Lewis, MD, MBA

Role: CONTACT

Phone: 617-726-2874

Email: [email protected]

Other Identifiers

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2009P001255

Identifier Type: -

Identifier Source: org_study_id