Precursors to PCOSPCOSNCT00559390
Research Study for Children With a Mother or Sister With Polycystic Ovary Syndrome
An observational study of Precursors to PCOS, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
In this study, we want to find out more about polycystic ovary syndrome(PCOS). This is a common problem in about 7% of teenage girls. Problems may include irregular periods, extra hair on the face, chest and back areas. Read more about this study
- Who is it for?
- Ages 8 to 12 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Precursors to PCOS
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Oct 2012
- 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 8 to 12 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Overweight girls between the ages of 8 and 12
Who may be able to join
- Relatives with polycystic ovary syndrome
- No relatives with polycystic ovary syndrome
- Overweight
- White non-hispanic girls
Who cannot join
- Chronic Illness
- Smokers
- Already having periods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Syndrome in PCOS: Precursors and Interventions
In this study, we want to find out more about polycystic ovary syndrome(PCOS). This is a common problem in about 7% of teenage girls. Problems may include irregular periods, extra hair on the face, chest and back areas. It seems that PCOS is related to a high level of male hormones and to another problem called metabolic syndrome(MBS). People with MBS may have high blood pressure, low good cholesterol, high blood fats and extra fat around the waist. Girls with MBS are at high risk for getting diabetes and heart disease.
Read the detailed description
Once enrolled in the study, you will have a physical exam done. This includes getting a medical history, height, weight, blood pressure and heart rate. We will also listen to your heart and lungs. We will also look at your skin and determine what stage of puberty you are in by looking at your breast growth and body hair. You will also have two (maybe three) blood tests. The first one is an oral glucose tolerance test (OGTT). During this test, we will have you drink an orange sugary drink and then we will draw your blood. The second test is a frequently sampled intravenous glucose tolerance test (FSIGT). During this test, we will give you insulin through one IV catheter and then we will draw blood from another IV catheter. The third test that you might have done is an ACTH test. During this test, we will draw your blood and then you will be given a dose of cortrosyn (a hormone that your body already makes) and then we will draw your blood again. You will also have two scans of your body done during your visit. There will be a Dual Energy X-Ray Scan (DEXA) and a Magnetic Resonance Imaging Scan (MRI). You will be placed in the machines and then the scanner will move over your body.
- Conditions
- Precursors to PCOS
- Keywords
- Polycystic Ovary Syndrome, Metabolic Syndrome, PCOS, children, girls, daughters, sisters, irregular periods
- Medical subject headings
- Polycystic Ovary Syndrome, Metabolic Syndrome, Menstruation Disturbances
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 |
|---|---|---|
| Pre-PCOS | First degree relatives, either sisters or daughters, of women with Polycystic Ovary Syndrome. | |
| Controls | Sisters and daughters of women who do not have PCOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
It is believed that PCOS is inherited. We are trying to look for clinical, blood and/or genetic markers of PCOS in the sisters and daughters of women with PCOS
Measured: age 8 until onset of menses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startJul 2006
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Precursors to PCOSStudies of the same condition, open and under way.
- 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern Memorial Hospital, Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Andrea Dunaif, Northwestern University
- Investigators
- Andrea Dunaif, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559390
- Sponsor's protocol ID
- 0956-023
- Other IDs
- R01DK040605, DK73411
- Acronym
- PCOS
- Status last verified
- Apr 2013
- First submitted
- 15 Nov 2007
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Urbanek M, Sam S, Legro RS, Dunaif A. Identification of a polycystic ovary syndrome susceptibility variant in fibrillin-3 and association with a metabolic phenotype. J Clin Endocrinol Metab. 2007 Nov;92(11):4191-8. doi: 10.1210/jc.2007-0761. Epub 2007 Sep 4.
PubMed 17785364
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome in PCOS: Precursors and Interventions
- ClinicalTrials.gov ID
- NCT00559390
- Acronym / sponsor ID
- PCOS / 0956-023
- Conditions
- Precursors to PCOS
- Keywords
- Polycystic Ovary Syndrome, Metabolic Syndrome, PCOS, children, girls, daughters, sisters, irregular periods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern Memorial Hospital, Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- Jul 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Nov 2007 (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.
In this study, we want to find out more about polycystic ovary syndrome(PCOS). This is a common problem in about 7% of teenage girls. Problems may include irregular periods, extra hair on the face, chest and back areas. It seems that PCOS is related to a high level of male hormones and to another problem called metabolic syndrome(MBS). People with MBS may have high blood pressure, low good cholesterol, high blood fats and extra fat around the waist. Girls with MBS are at high risk for getting diabetes and heart disease.
Detailed description
Once enrolled in the study, you will have a physical exam done. This includes getting a medical history, height, weight, blood pressure and heart rate. We will also listen to your heart and lungs. We will also look at your skin and determine what stage of puberty you are in by looking at your breast growth and body hair. You will also have two (maybe three) blood tests. The first one is an oral glucose tolerance test (OGTT). During this test, we will have you drink an orange sugary drink and then we will draw your blood. The second test is a frequently sampled intravenous glucose tolerance test (FSIGT). During this test, we will give you insulin through one IV catheter and then we will draw blood from another IV catheter. The third test that you might have done is an ACTH test. During this test, we will draw your blood and then you will be given a dose of cortrosyn (a hormone that your body already makes) and then we will draw your blood again. You will also have two scans of your body done during your visit. There will be a Dual Energy X-Ray Scan (DEXA) and a Magnetic Resonance Imaging Scan (MRI). You will be placed in the machines and then the scanner will move over your body.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-PCOS | – | –First degree relatives, either sisters or daughters, of women with Polycystic Ovary Syndrome. |
| Controls | – | –Sisters and daughters of women who do not have PCOS |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Overweight girls between the ages of 8 and 12
Key inclusion criteria (4 listed)
- Relatives with polycystic ovary syndrome
- No relatives with polycystic ovary syndrome
- Overweight
- White non-hispanic girls
Key exclusion criteria (3 listed)
- Chronic Illness
- Smokers
- Already having periods
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
It is believed that PCOS is inherited. We are trying to look for clinical, blood and/or genetic markers of PCOS in the sisters and daughters of women with PCOS
Time frame: age 8 until onset of menses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
- Background: PubMed 17785364Urbanek M, Sam S, Legro RS, Dunaif A. Identification of a polycystic ovary syndrome susceptibility variant in fibrillin-3 and association with a metabolic phenotype. J Clin Endocrinol Metab. 2007 Nov;92(11):4191-8. doi: 10.1210/jc.2007-0761. Epub 2007 Sep 4.
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.
Andrea Dunaif, MD principal investigator
Northwestern University
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 Precursors to PCOS, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 5 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
It is believed that PCOS is inherited. We are trying to look for clinical, blood and/or genetic markers of PCOS in the sisters and daughters of women with PCOS (time frame: age 8 until onset of menses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00559390, which also lists 1 linked publication.
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 5 Apr 2013.