Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ovarian Cancer, Insomnia Sleep Studies, Women's Studies, Pulmonary |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 10/4/2018 |
| Start Date: | December 2007 |
| End Date: | January 2019 |
PCOS, Sleep Apnea and Metabolic Risk in Women
The purpose of this study is to look at the metabolic (use of energy) and hormonal features
of sleep problems in women with polycystic ovary syndrome (PCOS).
of sleep problems in women with polycystic ovary syndrome (PCOS).
The prevalence of obesity and chronic sleep loss are at record levels among Americans and
evidence continues to emerge to support a causal link between the two conditions. Metabolic
abnormalities related to sleep disruption are particularly evident in individuals with
obstructive sleep apnea (OSA), a disorder traditionally associated with male gender. While
more prevalent in men, OSA is underrecognized in women in part because its clinical and
polysomnographic features differ from those of men. Women with polycystic ovary syndrome
(PCOS) are particularly susceptible to OSA with at least a 5-fold higher risk for its
development compared to obese women without PCOS. This study will enroll obese women with
PCOS, with and without OSA. Those with OSA will be randomized to receive CPAP or to receive
depot leuprolide to suppress ovarian steroid output over 12 weeks, reassessed at 6 weeks, and
then randomized (double-blind, placebo controlled) to 6 weeks of either micronized estrogen +
placebo or micronized progestin + placebo. The independent effects of androgen, estrogen, and
progesterone on OSA and metabolic function will be assessed. In addition, primary human
adipocytes will be prepared from fat biopsies obtained from subjects. Insulin sensitivity
will be determined by phospho-specific immunoblotting in conjunction with glucose uptake and
anti-lipolysis assays. In parallel, adipocytes from these subjects will be cultured for 1-5
days prior to metabolic assays to ascertain if removal of from circulating factors will
improve insulin signaling, or if insulin resistance persists in vitro. Finally, there will be
an interface with the Metabolomics Laboratory at Duke University (C. Newgard, Lab Director),
and metabolomics assessment will be done on blood and urine samples.
evidence continues to emerge to support a causal link between the two conditions. Metabolic
abnormalities related to sleep disruption are particularly evident in individuals with
obstructive sleep apnea (OSA), a disorder traditionally associated with male gender. While
more prevalent in men, OSA is underrecognized in women in part because its clinical and
polysomnographic features differ from those of men. Women with polycystic ovary syndrome
(PCOS) are particularly susceptible to OSA with at least a 5-fold higher risk for its
development compared to obese women without PCOS. This study will enroll obese women with
PCOS, with and without OSA. Those with OSA will be randomized to receive CPAP or to receive
depot leuprolide to suppress ovarian steroid output over 12 weeks, reassessed at 6 weeks, and
then randomized (double-blind, placebo controlled) to 6 weeks of either micronized estrogen +
placebo or micronized progestin + placebo. The independent effects of androgen, estrogen, and
progesterone on OSA and metabolic function will be assessed. In addition, primary human
adipocytes will be prepared from fat biopsies obtained from subjects. Insulin sensitivity
will be determined by phospho-specific immunoblotting in conjunction with glucose uptake and
anti-lipolysis assays. In parallel, adipocytes from these subjects will be cultured for 1-5
days prior to metabolic assays to ascertain if removal of from circulating factors will
improve insulin signaling, or if insulin resistance persists in vitro. Finally, there will be
an interface with the Metabolomics Laboratory at Duke University (C. Newgard, Lab Director),
and metabolomics assessment will be done on blood and urine samples.
Inclusion Criteria:
- Clinical diagnosis of PCOS
- Obese (BMI of at least 30 kg/m2)
Exclusion Criteria:
- Diagnosis of nonclassic 21-hydroxylase deficiency, Cushing syndrome, hypothyroidism,
or significant elevations in prolactin
- Taking steroid preparations (including oral contraceptives), medications known to
alter insulin secretion and/or action, or medications known to influence sleep during
the 2 months prior to starting the study
- Positive pregnancy test
- Diagnosis of diabetes mellitus
- Hypertension (systolic > 140 mmHg and/or diastolic > 90 mmhg) not well-controlled on
stable medication with either ACE inhibitors or diuretics
- Habitual alcohol use
- Excessive caffeine intake of more than 300 mg/day
- Known peanut allergies, or allergies to medications used in the study
- Hemoglobin < 11g/dL and/or hematocrit < 33%
- Systemic illnesses, including heart, renal, liver, or malignant disease
We found this trial at
1
site
Chicago, Illinois 60637
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