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

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
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Normal weight Controls
BMI <85%ile AND regular menses
|
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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
|
- 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
- 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.
- 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

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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 |
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)

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
United States, New York | |
Children's Hospital at Montefiore | |
Bronx, New York, United States, 10467 |
Principal Investigator: | Rubina Heptulla, MD | Montefiore Medical Center, Albert Einstein |
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 |