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

This study has been completed.
Sponsor:
Collaborators:
Northwestern Memorial Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Andrea Dunaif, Northwestern University
ClinicalTrials.gov Identifier:
NCT00559390
First received: November 15, 2007
Last updated: April 3, 2013
Last verified: April 2013

November 15, 2007
April 3, 2013
July 2006
October 2012   (final data collection date for 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 ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT00559390 on ClinicalTrials.gov Archive Site
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Research Study for Children With a Mother or Sister With Polycystic Ovary Syndrome
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.

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.

Observational
Observational Model: Family-Based
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole Blood, Serum and Plasma

Non-Probability Sample

Overweight girls between the ages of 8 and 12

Precursors to PCOS
Not Provided
  • 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
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. Epub 2007 Sep 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Female
8 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00559390
0956-023, R01DK040605, DK73411
Yes
Andrea Dunaif, Northwestern University
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.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP