Research Study for Children With a Mother or Sister With Polycystic Ovary Syndrome (PCOS)
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Purpose
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.
| Condition |
|---|
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Precursors to PCOS |
| Study Type: | Observational |
| Study Design: | Observational Model: Family-Based Time Perspective: Prospective |
| Official Title: | Metabolic Syndrome in PCOS: Precursors and Interventions |
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole Blood, Serum and Plasma
| Enrollment: | 136 |
| Study Start Date: | July 2006 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Pre-PCOS
First degree relatives, either sisters or daughters, of women with Polycystic Ovary Syndrome.
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Controls
Sisters and daughters of women who do not have PCOS
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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.
Eligibility| Ages Eligible for Study: | 8 Years to 12 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Overweight girls between the ages of 8 and 12
Inclusion Criteria:
- Relatives with polycystic ovary syndrome
- No relatives with polycystic ovary syndrome
- Overweight
- White non-hispanic girls
Exclusion Criteria:
- Chronic Illness
- Smokers
- Already having periods
Contacts and Locations| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Andrea Dunaif, MD | Northwestern University-Chicago, Il. |
More Information
Additional Information:
Publications:
| Responsible Party: | Andrea Dunaif, Principal Investigator, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00559390 History of Changes |
| Other Study ID Numbers: | 0956-023, R01DK040605, DK73411 |
| Study First Received: | November 15, 2007 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Polycystic Ovary Syndrome Metabolic Syndrome PCOS children |
girls daughters sisters irregular periods |
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome Metabolic Syndrome X Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013