Eligibility Details:
Inclusion Criteria:
Inclusion criteria for all participants:
- Subjects will be 18-35 years old; we use a cutoff age of 35 y because early menopause
at this age is very rare.
- No significant health problems (other than PCOS and obesity).
- Subjects will be willing to strictly avoid pregnancy (using non-hormonal methods)
during the time of study and must be willing and able to provide informed consent.
Inclusion criteria for normal controls:
- Controls will be healthy women with regular menstrual cycles and no evidence of
hyperandrogenism.
Inclusion criteria for PCOS:
- PCOS will be defined according to NIH consensus criteria.
- As such, subjects with PCOS will have hyperandrogenism, whether it is clinical
(e.g., hirsutism) or biochemical (i.e., elevated plasma T).
- Subjects with PCOS will also have oligo- or amenorrhea (i.e., < 7 periods per
year) and no evidence for other endocrinopathies (e.g., hyperprolactinemia,
Cushing's syndrome, etc.).
Exclusion Criteria:
- Being a study of GnRH pulse regulation in women with and without PCOS, men are
excluded.
- Obesity associated with a diagnosed (genetic) syndrome, obesity related to medications
(e.g., glucocorticoids), etc.
- Pregnancy or lactation.
- Virilization.
- A total testosterone > 150 ng/dl in women with PCOS (which suggests the possibility of
a virilizing neoplasm) (confirmed on repeat).
- Elevated DHEAS (mild elevations may be seen in PCOS, and elevations < 1.5 times the
upper limit of normal will be accepted in PCOS)(confirmed on repeat).
- Follicular 17-hydroxyprogesterone > 300 ng/dl, which suggests the possibility of
congenital adrenal hyperplasia (if elevated during the luteal phase and there is a
concern about the possibility of congenital adrenal hyperplasia, the
17-hydroxyprogesterone may be collected during the follicular phase, or >60 if
oligomenorrheic).
*NOTE: If a 17-hydroxyprogesterone > 300 ng/dl is confirmed on such repeat testing, an
ACTH stimulated 17-hydroxyprogesterone < 1000 ng/dl will be required for study
participation.
- A previous diagnosis of diabetes, a fasting glucose ≥ 126 mg/dl, or a hemoglobin A1c >
6.5%
- Abnormal TSH (subjects with adequately treated hypothyroidism, reflected by normal TSH
values, will not be excluded; or, for a new diagnosis of hypothyroidism, further study
will at the least be delayed pending appropriate treatment) (confirmed on repeat).
- Abnormal prolactin (mild elevations may be seen in PCOS, and elevations < 1.5 times
the upper limit of normal will be accepted in this group) (confirmed on repeat).
- Evidence of Cushing's syndrome by history or physical exam.
- Hematocrit < 36% or hemoglobin < 12 g/dl (that is not reversed by iron treatment).
- Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected
congestive heart failure; asthma requiring intermittent systemic corticosteroids;
etc.)
- Liver test abnormalities (confirmed on repeat), with the exception that mild bilirubin
elevations will be accepted in the setting of known Gilbert's syndrome.
- Abnormal sodium or potassium (confirmed on repeat); bicarbonate concentration <20 or
>30 (confirmed on repeat); or elevated creatinine concentration (confirmed on repeat).
- Due to the amount of blood being drawn in the study, subjects with body weight < 110
lbs will be excluded from the study.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
