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

Precursors to PCOS Clinical Trial

— PCOS  

Official title:

Metabolic Syndrome in PCOS: Precursors and Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559390
• Other study ID #: 0956-023
• Secondary ID: R01DK040605DK734
• Status: Completed
• Phase: N/A
• First received: November 15, 2007
• Last updated: April 3, 2013
• Start date: July 2006
• Est. completion date: October 2012

Study information

• Verified date: April 2013
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 8 Years to 12 Years

Eligibility

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

Study Design

Observational Model: Family-Based, Time Perspective: Prospective

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Precursors to PCOS

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Ann & Robert H Lurie Children's Hospital of Chicago, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern Memorial Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		age 8 until onset of menses	No

External Links

•   Northwestern University PCOS Research