Polycystic Ovary Syndrome (PCOS) and Sleep Apnea
Condition: Polycystic Ovary Syndrome; Obstructive Sleep Apnea
MeSH terms: Polycystic Ovary Syndrome; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Intervention: continuous positive airway pressure (CPAP); depot leuprolide plus estrogen/progestin replacement; pioglitazone; REM frag; SWS supp
Intervention description: CPAP is the most effective treatment available for sleep disordered breathing. CPAP provides a constant, controllable pressure to keep your upper airway open during sleep so that you can breathe normally. The pressure acts much in the same way as a splint and holds the airway open.; Depot leuprolide is a long-acting, modified version of the natural brain hormone, gonadotropin releasing hormone (GnRH). This study drug will temporarily reduce the pituitary hormones that stimulate the ovaries to make both female (estrogen) and male (testosterone) hormones. The effect of this study drug will last approximately 12 weeks. During this time, your female hormone levels will be brought to normal by the use of a patch that contains estrogen and progesterone. This patch is placed on the skin and is changed twice a week. The subject will continue to wear this patch for 4 weeks after the end of the study, until the effects of the Lupron injection wear off.; Pioglitazone (Actos). Pioglitazone is an oral medication approved in the Unites States for the treatment of patients with type 2 diabetes (however it is not approved for studies in this protocol). This is one of a class of drugs known as thiazolidinediones. This class of drugs has been associated with potential beneficial changes in the metabolism (use of glucose by the body) as well as lipids (fats) in the blood.; Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.; SWS: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
Intervention MeSH terms: Pioglitazone; Leuprolide; Estrogens; Progestins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: polycystic ovary syndrome; metabolic syndrome; obstructive sleep apnea; impaired glucose tolerance; insulin resistance

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 with PCOS suffer at an early stage of adulthood from all of the components of
      the metabolic syndrome, a syndrome that typically has its peak in mid-life in other subject
      populations. Women with PCOS are more insulin resistant than weight-matched control women and
      have exceptionally high rates of early-onset impaired glucose tolerance and type 2 diabetes,
      as well as a substantially elevated risk for hypertension, dyslipidemia, coronary, and other
      vascular diseases. While recent evidence indicates that the prevalence of sleep-disordered
      breathing (SDB) is 30-40 fold higher in PCOS than in weight-matched control women, the
      possible role of SDB in causing the increased metabolic and cardiovascular risks of PCOS has
      not been evaluated. The overall objective of the proposed study is to analyze the direction
      of causality between sleep disturbances and markers of the metabolic syndrome in PCOS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.