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

NCT ID: NCT00559390

Last Updated: 2013-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2012-10-31

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.

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.

Conditions

Precursors to PCOS

Study Design

• Observational Model Type: FAMILY_BASED
• Study Time Perspective: PROSPECTIVE

Study Groups

Pre-PCOS

First degree relatives, either sisters or daughters, of women with Polycystic Ovary Syndrome.

No interventions assigned to this group

Controls

Sisters and daughters of women who do not have PCOS

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Northwestern Memorial Hospital

OTHER

Sponsor Role: collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: lead

Responsible Party

Andrea Dunaif

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Dunaif, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University, Chicago, IL

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

References

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. doi: 10.1210/jc.2007-0761. Epub 2007 Sep 4.

Reference Type: BACKGROUND

PMID: 17785364 (View on PubMed)

Other Identifiers

R01DK040605

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK73411

Identifier Type: -

Identifier Source: secondary_id

0956-023

Identifier Type: -

Identifier Source: org_study_id