Evaluation of the Ovarian Dynamic Response and the Inflammatory Response to Oral Lipid Challenge in Relation to Body Composition in Polycystic Ovary Syndrome
The investigator hypothesizes that in women with PCOS, HCG administration will stimulate an
exaggerated ovarian androgen response, dairy cream ingestion will stimulate white blood
cells to generate an inflammatory response, and that there is a relationship between
HCG-stimulated ovarian androgen secretion and the inflammatory response to dairy cream
ingestion regardless of body fat status. Thirty (30) women with PCOS (10 normal weight with
normal abdominal adiposity, 10 normal weight with increased abdominal adiposity and 10
obese) and 30 ovulatory control women (10 normal weight with normal abdominal adiposity, 10
normal weight with increased abdominal adiposity and 10 obese) will participate over a
The investigator also hypothesizes that both salsalate and PCE administration for 12 weeks
will attenuate the ovarian androgen response to HCG administration and the inflammatory
response to dairy cream ingestion, reduce abdominal adiposity, increase insulin sensitivity
and induce ovulation in normal weight women with PCOS. A subset of 16 women with PCOS of
which 8 will receive salsalate (4 normal weight with normal abdominal adiposity and 4 normal
weight with increased abdominal adiposity) and 8 will receive PCE (4 normal weight with
normal abdominal adiposity and 4 normal weight with increased abdominal adiposity) will
participate in this intervention over a 3-year period. This pilot project will help
determine the feasibility of conducting a larger double-blind, randomized trial in women
with PCOS to further test the latter hypothesis.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
White blood cell nuclear factor kappa B (NFkappaB) activation in response to oral lipid ingestion and ovarian androgen secretion in response to human chorionic gonadotropin (HCG) stimulation.
This outcome along with insulin sensitivity derived from an oral glucose tolerance test (OGTT) and body composition measured by dual energy absorptiometry (DEXA) will be assessed in all study subjects (PCOS and controls).
Frank González, M.D.
United States: Food and Drug Administration
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