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.
Brief Title
Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents
Detailed Description
See above.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Obstructive Sleep Apnea Syndrome
Polycystic Ovary Syndrome
Sleep Apnea
Eligibility 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)
* 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)
Inclusion 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
* Female.
* Ages 13-21
* PCOS
* BMI \>95%ile (Obese group) or \<85%ile (Lean group)
* Controls: ages 18-21, regular menses, BMI \<85%ile
Gender
Female
Gender Based
false
Keywords
insulin function
sleep apnea
girls
PCOS
insulin action
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
21 Years
Minimum Age
13 Years
NCT Id
NCT01840618
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
11-09-336E
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents
Primary Outcomes
Outcome Description
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
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
Outcome Time Frame
baseline to two years
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
baseline to two years
Outcome Measure
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.
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Girls with PCOS, with and without sleep apnea. Ages 13-21.
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
21
Minimum Age Number (converted to Years and rounded down)
13
Investigators
Investigator Type
Principal Investigator
Investigator Name
Lisa Underland
Investigator Email
lunderla@montefiore.org
Investigator Phone
832-867-4580
Categories Mesh Debug
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Mental Health & Behavioral Research --- SLEEP DISORDERS, INTRINSIC
Mental Health & Behavioral Research --- DYSSOMNIAS
Mental Health & Behavioral Research --- SLEEP WAKE DISORDERS
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
Cancer --- NEOPLASMS
Endocrine System Cancers --- ENDOCRINE SYSTEM DISEASES
Diabetes --- ENDOCRINE SYSTEM DISEASES
Diabetes & Endocrine System --- ENDOCRINE SYSTEM DISEASES
MeSH Terms
SLEEP APNEA, OBSTRUCTIVE
POLYCYSTIC OVARY SYNDROME
SLEEP APNEA SYNDROMES
APNEA
RESPIRATION DISORDERS
RESPIRATORY TRACT DISEASES
SLEEP DISORDERS, INTRINSIC
DYSSOMNIAS
SLEEP WAKE DISORDERS
NERVOUS SYSTEM DISEASES
OVARIAN CYSTS
CYSTS
NEOPLASMS
OVARIAN DISEASES
ADNEXAL DISEASES
GENITAL DISEASES, FEMALE
FEMALE UROGENITAL DISEASES
FEMALE UROGENITAL DISEASES AND PREGNANCY COMPLICATIONS
UROGENITAL DISEASES
GENITAL DISEASES
GONADAL DISORDERS
ENDOCRINE SYSTEM DISEASES
CONTINUOUS POSITIVE AIRWAY PRESSURE
POSITIVE-PRESSURE RESPIRATION
RESPIRATION, ARTIFICIAL
AIRWAY MANAGEMENT
THERAPEUTICS
RESPIRATORY THERAPY