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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Information provided by (Responsible Party):
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01840618
First received: July 12, 2012
Last updated: September 10, 2014
Last verified: September 2014

July 12, 2012
September 10, 2014
February 2012
January 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
  • The purpose of this study is to understand how endothelial function as a surrogate marker for cardiovascular risk is affected in presence of sleep apnea in girls with PCOS between 13-18 years of age as compared to girls with PCOS without sleep apnea. [ Time Frame: baseline to two years ] [ Designated as safety issue: No ]
    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 Reactive Hyperemia Peripheral Arterial Tonometry (RHPAT) score.
  • The purpose of this study is to understand how insulin function is affected in presence of sleep apnea in girls with PCOS between 13-18 years of age as compared to girls with PCOS without sleep apnea. [ Time Frame: baseline to two years ] [ Designated as safety issue: No ]
    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
Complete list of historical versions of study NCT01840618 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Same as current
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 ] [ Designated as safety issue: No ]
Insulin sensitivity will be compared in adolescents with non-obese PCOS (BMI ≤85%) to non-obese adolescents (BMI ≤85%) without PCOS
Not Provided
 
Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents
Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents

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.

See above.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Blood

Probability Sample

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

  • Obstructive Sleep Apnea Syndrome
  • Polycystic Ovary Syndrome
  • Sleep Apnea
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 and sleep apnea

    BMI >95%ile AND Polysomnography with AHI >2.5

    Will initiate Nasal Continuous positive airway pressure (CPAP)

    Intervention: 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)

    Intervention: Device: Nasal Continuous positive airway pressure (CPAP)
  • Lean PCOS without sleep apnea
    BMI <85%ile AND Polysomnography with AHI <2.5
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2015
January 2015   (final data collection date for primary outcome measure)

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)
Female
13 Years to 21 Years
Yes
Contact: Lisa Kenigsberg, MD 718-920-7765 lkenigsb@montefiore.org
United States
 
NCT01840618
11-09-336E
Yes
Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
Not Provided
Principal Investigator: Rubina Heptulla, MD Montefiore Medical Center, Albert Einstein
Albert Einstein College of Medicine of Yeshiva University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP