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
  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
Precursors to PCOS

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Metabolic Syndrome in PCOS: Precursors and Interventions

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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
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

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
Study Population

Overweight girls between the ages of 8 and 12

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559390

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern Memorial Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
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:
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 July 24, 2014