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

August 26, 2019 updated by: Albert Einstein College of Medicine
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

See above.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline to two years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
baseline to two years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
baseline to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Albert Einstein College of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa Underland, MD, Montefiore Medical Center, Albert Einstein

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11-09-336E

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