Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents
- Conditions
- Obstructive Sleep Apnea SyndromeSleep ApneaPolycystic Ovary Syndrome
- Interventions
- Device: Nasal Continuous positive airway pressure (CPAP)
- Registration Number
- NCT01840618
- Lead Sponsor
- Albert Einstein College of Medicine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- Female.
- Ages 13-21
- PCOS
- BMI >95%ile (Obese group) or <85%ile (Lean group)
- Controls: ages 18-21, regular menses, BMI <85%ile
- Breastfeeding.
- Pregnant.
- Use of any steroid preparations (including hormonal contraception), medications known to alter insulin secretion and/or action within 3 month (including Metformin)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Obese PCOS and sleep apnea Nasal Continuous positive airway pressure (CPAP) BMI \>95%ile AND Polysomnography with AHI \>2.5 Will initiate Nasal Continuous positive airway pressure (CPAP) Lean PCOS and sleep apnea Nasal Continuous positive airway pressure (CPAP) BMI \<85%ile AND Polysomnography with AHI \>2.5 Will initiate Nasal Continuous positive airway pressure (CPAP)
- Primary Outcome Measures
Name Time Method 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 baseline to two years Obese adolescents with PCOS will be assessed for presence or absence of Obstructive Sleep Apnea (OSA) at baseline. Obese PCOS with OSA will be compared with obese PCOS with out OSA for difference in Glucose Infusion Rate (GIR) as a measure of insulin resistance and for Reactive Hyperemia Peripheral Arterial Tonometry (RHPAT) score
- Secondary Outcome Measures
Name Time Method 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. baseline to two years Obese adolescents with PCOS will be assessed for presence or absence of Obstructive Sleep Apnea (OSA) at baseline. Obese PCOS with OSA will be compared with obese PCOS with out OSA for increase in the levels of leptin, CRP, TNF alpha, free fatty acids and the reduction in the levels of adiponectin compared to Non OSA adolescents with PCOS.
Trial Locations
- Locations (1)
Children's Hospital at Montefiore
🇺🇸Bronx, New York, United States