Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk
1 other identifier
observational
96
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2007
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 26, 2007
CompletedFirst Posted
Study publicly available on registry
October 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedAugust 29, 2013
August 1, 2013
6.1 years
October 26, 2007
August 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
endothelial function
same day
Study Arms (4)
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 Criteria
Black and white women who have had uncomplicated pregnancies or pregnancies complicated by gestational diabetes in the past 5 years
You may qualify if:
- Healthy women of self-identified African descent (black) and European (white) ancestry
- years of age
- Regular menstrual cycles
- 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
You may not qualify if:
- If you are pregnant
- If you are lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Massachusetts General Hospitalcollaborator
- Joslin Diabetes Centercollaborator
Study Sites (2)
Brigham and Women's Hospital, Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Biospecimen
blood and urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rhonda Bentley-Lewis, MD
Brigham and Women's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Rhonda Bentley-Lewis, MD, MBA, MMSc
Study Record Dates
First Submitted
October 26, 2007
First Posted
October 30, 2007
Study Start
September 1, 2007
Primary Completion
October 1, 2013
Study Completion
January 1, 2014
Last Updated
August 29, 2013
Record last verified: 2013-08