Status:
TERMINATED
Polycystic Ovary Syndrome (PCOS) and Sleep Apnea
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Polycystic Ovary Syndrome
Obstructive Sleep Apnea
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
Brief Summary
Polycystic ovary syndrome (PCOS) affects 5-10% of women in the United States. Its onset is usually at the time of puberty with manifestations of menstrual irregularity, hirsutism, and obesity. Women w...
Detailed Description
Polycystic ovary syndrome (PCOS) affects 5-10% of women and may be viewed as the combination of hyperandrogenism with the classical features of the metabolic syndrome in young women. PCOS presents a u...
Eligibility Criteria
Inclusion
- PCOS subjects will be recruited from the Endocrinology Clinics of the University of Chicago. All will be at least 2 years post-menarche and less than 40 years of age. A diagnosis of PCOS will require:
- the presence of oligo/amenorrhea;
- hyperandrogenemia, defined by a supranormal plasma free testosterone level (\> 10 pg/ml);
- hyperandrogenism, as evidenced by infertility, hirsutism, acne, or androgenetic alopecia; and
- exclusion of nonclassic 21-hydroxylase deficiency congenital adrenal hyperplasia, Cushing's syndrome, hypothyroidism, or significant elevations in serum prolactin. Thus, all subjects will meet the National Institutes of Health (NIH) consensus criteria for PCOS.
- Control subjects will be matched, as closely as possible, for age, ethnicity, body mass index (BMI), and body fat distribution \[as assessed by single cut abdominal computed tomography (CT) scan and dual energy x-ray absorptiometry (DEXA) scan\].
- Normal lean (BMI \<25 kg/m2) women will be between 18 and 40 years of age, in good health, with normal menstrual cycles, no sleep complaints, no history of endocrine disorder. All studies will be initiated in the early follicular phase (days 2-4).
Exclusion
- For at least 2 months before the study, all subjects (PCOS and control) must not take steroid preparations (including oral contraceptives), medications known to alter insulin secretion and/or action, or medications known to influence sleep.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00203996
Start Date
September 1 2003
End Date
June 1 2008
Last Update
March 21 2023
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637