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

NCT01840618 | Completed DMC

• 1 other identifier: 11-09-336E
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea Syndrome; Polycystic Ovary Syndrome; Sleep Apnea

Keywords

insulin function; sleep apnea; girls; PCOS; insulin action

Outcome Measures

Primary Outcomes (1)

• 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

  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

  baseline to two years

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• 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.

  baseline to two years

Study Arms (5)

Obese PCOS and sleep apnea

BMI \>95%ile AND Polysomnography with AHI \>2.5 Will initiate Nasal Continuous positive airway pressure (CPAP)

Device: Nasal Continuous positive airway pressure (CPAP)

Obese PCOS without sleep apnea

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

Normal weight Controls

BMI \<85%ile AND regular menses

Lean PCOS and sleep apnea

BMI \<85%ile AND Polysomnography with AHI \>2.5 Will initiate Nasal Continuous positive airway pressure (CPAP)

Device: Nasal Continuous positive airway pressure (CPAP)

Lean PCOS without sleep apnea

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

Interventions

Nasal Continuous positive airway pressure (CPAP) 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 and sleep apnea; Obese PCOS and sleep apnea

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Girls with PCOS, with and without sleep apnea. Ages 13-21.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Polycystic Ovary Syndrome; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Lisa Underland, MD

  Montefiore Medical Center, Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: April 26, 2013
• Study Start: February 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

US (1)