Clinical trial NCT01840618: Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents
Official title: Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea Syndrome
Polycystic Ovary Syndrome
Sleep Apnea
Keywords: insulin function
sleep apnea
girls
PCOS
insulin action
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Girls with PCOS, with and without sleep apnea. Ages 13-21.

Brief summary: Polycystic ovary syndrome (PCOS) is one of the most common disease caused by hormonal imbalance and is also associated with overweight and obesity. It affects 5-10% of adolescent girls and women capable of having children. Polycystic ovary syndrome is associated with missed menstrual periods, hormonal imbalance, being overweight, and with a form of diabetes. Girls with polycystic ovary syndrome may have a breathing problem known as "sleep apnea." Sleep apnea may cause a person to stop breathing for short periods of time while sleeping. People with polycystic ovary syndrome are thirty times more likely to develop sleep apnea than those who do not have PCOS. If sleep apnea is not treated, it may lead to daytime sleepiness, poor school performance, high blood pressure, heart disease and diabetes. The purpose of this study is to understand how insulin function is affected in presence of sleep apnea in girls with polycystic ovary syndrome between 13-21 years of age as compared to girls with PCOS without sleep apnea. Insulin is one of the hormones made in your body to convert food into energy. In people with increase weight body cannot use insulin properly. The investigators also want to see if insulin action is also affected by sleep apnea.

Detailed description: See above.

Eligibility criteria: Inclusion Criteria:

* Female.
* Ages 13-21
* PCOS
* BMI \>95%ile (Obese group) or \<85%ile (Lean group)
* Controls: ages 18-21, regular menses, BMI \<85%ile

Exclusion Criteria:

* Breastfeeding.
* Pregnant.
* Use of any steroid preparations (including hormonal contraception), medications known to alter insulin secretion and/or action within 3 month (including Metformin)

Primary outcomes:
measure: The purpose of this study is to understand how insulin function is affected and how endothelial function as a surrogate marker for cardiovascular risk is affected in presence of sleep apnea as compared to girls (13-21 yrs) with PCOS without sleep apnea
timeFrame: baseline to two years
Secondary outcomes:
measure: We also want to see if there is any change in the levels of adipocytokines (Leptin, adiponectin, C Reactive Protein (CRP), Tumor Necrosis Factor (TNF) alpha, Free fatty acids) because of sleep apnea in obese PCOS adolescents.
timeFrame: baseline to two years
Other outcomes:
measure: The purpose of this study is to to determine the role that PCOS plays in insulin resistance in non-obese adolescents by comparing insulin resistance in adolescent girls ages 13-21 with lean PCOS to normal weight adolescents ages 18-21 without PCOS.
timeFrame: baseline to two years
Locations:
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
Study officials:
affiliation: Montefiore Medical Center, Albert Einstein
name: Lisa Underland, MD
role: PRINCIPAL_INVESTIGATOR
References: