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 January 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: January 30, 2014
Last verified: January 2014

July 12, 2012
January 30, 2014
February 2012
October 2014   (final data collection date for primary outcome measure)
  • 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
  • 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.
Same as current
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
Not Provided
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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. PCOS is associated with missed menstrual periods, hormonal imbalance, being overweight, and with a form of diabetes. Girls with PCOS 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 PCOS 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 PCOS between 13-18 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
Not Provided
Probability Sample

Girls with PCOS, with and without sleep apnea. Ages 13-18.

  • 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.
  • PCOS and sleep apnea
    Intervention: Device: Nasal Continuous positive airway pressure (CPAP)
  • PCOS without sleep apnea
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2015
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female.
  • Ages 13-18.
  • PCOS.

Exclusion Criteria:

  • Breastfeeding.
  • Pregnant.
Female
13 Years to 18 Years
No
Contact: Chhavi Agarwal, MD 718-920-4664 cagarwal@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: Chhavi Agarwal, MD Montefiore Medical Center, Albert Einstein
Albert Einstein College of Medicine of Yeshiva University
January 2014

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