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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Obstructive Sleep Apnea Syndrome; Polycystic Ovary Syndrome; Sleep Apnea	Device: Nasal Continuous positive airway pressure (CPAP)

Detailed Description:

See above.

Study Design

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Study Type :	Observational
Actual Enrollment :	50 participants
Observational Model:	Case-Control
Time Perspective:	Cross-Sectional
Official Title:	Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents
Study Start Date :	February 2012
Actual Primary Completion Date :	June 2015
Actual Study Completion Date :	June 2015

Groups and Cohorts

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Group/Cohort	Intervention/treatment
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); 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
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); 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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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 [ Time Frame: 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 :

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. [ Time Frame: 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.

Other Outcome Measures:

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. [ Time Frame: baseline to two years ]
   Insulin sensitivity will be compared in adolescents with non-obese PCOS (BMI ≤85%) to non-obese adolescents (BMI ≤85%) without PCOS

Biospecimen Retention:   Samples Without DNA

Blood

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	13 Years to 21 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

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

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)

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New York
Children's Hospital at Montefiore
Bronx, New York, United States, 10467

Sponsors and Collaborators

Albert Einstein College of Medicine, Inc.

Investigators

Principal Investigator:	Rubina Heptulla, MD	Montefiore Medical Center, Albert Einstein

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier:	NCT01840618 History of Changes
Other Study ID Numbers:	11-09-336E
First Posted:	April 26, 2013
Last Update Posted:	April 19, 2018
Last Verified:	June 2015

Keywords provided by Albert Einstein College of Medicine, Inc.:

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

Additional relevant MeSH terms:

Syndrome; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Polycystic Ovary Syndrome; Insulin Resistance; Disease; Pathologic Processes; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders	Nervous System Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Insulin, Globin Zinc; Insulin; Hypoglycemic Agents