Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk

NCT ID: NCT00550979

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

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

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 in women who have had a pregnancy complicated by diabetes as compared with women who have had a normal pregnancy.

Detailed Description

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Conditions

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Gestational Diabetes Mellitus

Keywords

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gestational diabetes mellitus cardiovascular disease risk heart disease risk

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Black women with history of pregnancy/ies complicated by gestational diabetes mellitus

No interventions assigned to this group

2

Black women with history of normal, uncomplicated pregnancy/ies

No interventions assigned to this group

3

White women with a history of pregnancy/ies complicated by gestational diabetes.

No interventions assigned to this group

4

White women with a history of normal, uncomplicated pregnancy/ies.

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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Joslin Diabetes Center

OTHER

Sponsor Role collaborator

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

Principal Investigators

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Rhonda Bentley-Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital, Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Brigham and Women's 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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2007P001406

Identifier Type: -

Identifier Source: org_study_id