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

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ClinicalTrials.gov Identifier: NCT01840618
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Albert Einstein College of Medicine, Inc.

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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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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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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840618


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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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    Key Record Dates
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