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Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents

Albert Einstein College of Medicine logo

Albert Einstein College of Medicine

Status

Completed

Conditions

Polycystic Ovary Syndrome
Obstructive Sleep Apnea Syndrome
Sleep Apnea

Treatments

Device: Nasal Continuous positive airway pressure (CPAP)

Study type

Observational

Funder types

Other

Identifiers

NCT01840618
11-09-336E

Details and patient eligibility

About

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.

Full description

See above.

Enrollment

50 patients

Sex

Female

Ages

13 to 21 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

50 participants in 5 patient groups

Obese PCOS and sleep apnea
Description:
BMI \>95%ile AND Polysomnography with AHI \>2.5 Will initiate Nasal Continuous positive airway pressure (CPAP)
Treatment:
Device: Nasal Continuous positive airway pressure (CPAP)
Obese PCOS without sleep apnea
Description:
BMI \>95%ile AND Polysomnography with AHI \<2.5
Normal weight Controls
Description:
BMI \<85%ile AND regular menses
Lean PCOS and sleep apnea
Description:
BMI \<85%ile AND Polysomnography with AHI \>2.5 Will initiate Nasal Continuous positive airway pressure (CPAP)
Treatment:
Device: Nasal Continuous positive airway pressure (CPAP)
Lean PCOS without sleep apnea
Description:
BMI \<85%ile AND Polysomnography with AHI \<2.5

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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