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

NCT ID: NCT01840618

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-06-30

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.

Conditions

Obstructive Sleep Apnea Syndrome; Polycystic Ovary Syndrome; Sleep Apnea

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Obese PCOS and sleep apnea

BMI >95%ile AND Polysomnography with AHI >2.5

Will initiate Nasal Continuous positive airway pressure (CPAP)

Nasal Continuous positive airway pressure (CPAP)

Intervention Type: DEVICE

We will initiate treatment of OSA with CPAP for 3 months in PCOS adolescents with moderate to severe OSA. Compliance will be defined as the average number of hours for which CPAP was used per night over the 12-wk treatment period. Adherence with CPAP will be defined as CPAP use ≥4 hours daily. The primary outcome variable will be insulin sensitivity measured as change in GIR. Changes in cardio metabolic variables after CPAP treatment will be expressed as a percentage of the corresponding baseline values.

Obese PCOS without sleep apnea

BMI \>95%ile AND Polysomnography with AHI \<2.5

No interventions assigned to this group

Normal weight Controls

BMI \<85%ile AND regular menses

No interventions assigned to this group

Lean PCOS and sleep apnea

BMI <85%ile AND Polysomnography with AHI >2.5

Will initiate Nasal Continuous positive airway pressure (CPAP)

Nasal Continuous positive airway pressure (CPAP)

Intervention Type: DEVICE

We will initiate treatment of OSA with CPAP for 3 months in PCOS adolescents with moderate to severe OSA. Compliance will be defined as the average number of hours for which CPAP was used per night over the 12-wk treatment period. Adherence with CPAP will be defined as CPAP use ≥4 hours daily. The primary outcome variable will be insulin sensitivity measured as change in GIR. Changes in cardio metabolic variables after CPAP treatment will be expressed as a percentage of the corresponding baseline values.

Lean PCOS without sleep apnea

BMI \<85%ile AND Polysomnography with AHI \<2.5

No interventions assigned to this group

Interventions

Nasal Continuous positive airway pressure (CPAP)

We will initiate treatment of OSA with CPAP for 3 months in PCOS adolescents with moderate to severe OSA. Compliance will be defined as the average number of hours for which CPAP was used per night over the 12-wk treatment period. Adherence with CPAP will be defined as CPAP use ≥4 hours daily. The primary outcome variable will be insulin sensitivity measured as change in GIR. Changes in cardio metabolic variables after CPAP treatment will be expressed as a percentage of the corresponding baseline values.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Underland, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center, Albert Einstein

Locations

Children's Hospital at Montefiore

The Bronx, New York, United States

Countries

United States

Other Identifiers

11-09-336E

Identifier Type: -

Identifier Source: org_study_id