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Research Study for Children With a Mother or Sister With Polycystic Ovary Syndrome (PCOS)

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ClinicalTrials.gov Identifier: NCT00559390
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : April 5, 2013
Information provided by (Responsible Party):

Study Description
Brief 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. 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 or disease
Precursors to PCOS

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

Study Type : Observational
Actual Enrollment : 136 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Metabolic Syndrome in PCOS: Precursors and Interventions
Study Start Date : July 2006
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

First degree relatives, either sisters or daughters, of women with Polycystic Ovary Syndrome.
Sisters and daughters of women who do not have PCOS

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Whole Blood, Serum and Plasma

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559390

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Northwestern Memorial Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator: Andrea Dunaif, MD Northwestern University, Chicago, IL
More Information

Additional Information:
Responsible Party: Andrea Dunaif, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT00559390     History of Changes
Other Study ID Numbers: 0956-023
R01DK040605 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013

Keywords provided by Andrea Dunaif, Northwestern University:
Polycystic Ovary Syndrome
Metabolic Syndrome
irregular periods

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases