Gestational Diabetes MellitusNCT00998712
Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction
An observational study of Gestational Diabetes Mellitus and Pregnancy, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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 between black women and white women who have or do not have gestational diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus, Pregnancy
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Black and white women currently in the thrid trimester of a pregnancy complicated or uncomplicated by gestational diabetes.
Who may be able to join
- 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.
Who cannot join
- History of smoking
- Are taking potentially vasoactive medications
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital, Massachusetts General Hospital
Boston, Massachusetts, 02115
Rhonda Bentley-Lewis, MD
Mark Creager, MD
About this study
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.
- Conditions
- Gestational Diabetes Mellitus, Pregnancy
- Keywords
- gestational diabetes mellitus, pregnancy, cardiovascular disease risk
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function
Measured: same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rhonda Bentley-Lewis, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998712
- Sponsor's protocol ID
- 2009P001255
- Status last verified
- Aug 2013
- First submitted
- 16 Oct 2009
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction
- ClinicalTrials.gov ID
- NCT00998712
- Acronym / sponsor ID
- 2009P001255
- Conditions
- Gestational Diabetes Mellitus, Pregnancy
- Keywords
- gestational diabetes mellitus, pregnancy, cardiovascular disease risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Black and white women currently in the thrid trimester of a pregnancy complicated or uncomplicated by gestational diabetes.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (2 listed)
- History of smoking
- Are taking potentially vasoactive medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
endothelial function
Time frame: same day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus and Pregnancy, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Research Assistant (617-724-3504, RBLResearchGroup@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial function (time frame: same day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2013.