Evaluation of Oral Lipid Ingestion in Relation to Ovarian Androgen Secretion in Polycystic Ovary Syndrome (PCOS)
Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome
Intervention: Salsalate (Drug); Salsalate (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Indiana University Official(s) and/or principal investigator(s): Frank González, M.D., Principal Investigator, Affiliation: Indiana University
Overall contact: Frank González, M.D., Phone: (317) 948-7064, Email: gonzalef@iupui.edu
Summary
The purpose of this study is to determine the relationship between lipid-induced
inflammation and ovarian androgen secretion in women with polycystic ovary syndrome (PCOS);
and to examine the effect of salsalate and polygonum cuspidatum extract (PCE) containing
resveratrol on lipid-induced inflammation, ovarian androgen secretion, body composition and
ovulation in a subset of normal weight women with PCOS.
Clinical Details
Official title: Evaluation of the Ovarian Dynamic Response and the Inflammatory Response to Oral Lipid Challenge in Relation to Body Composition in Polycystic Ovary Syndrome
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: 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.
Secondary outcome: White blood cell NFkappaB activation following oral lipid ingestion in response to 12 weeks of salsalate or PCE administration.Ovarian androgen secretion following HCG administration in response to 12 weeks of salsalate or PCE administration. Body composition status measured by DEXA in response to 12 weeks of salsalate or PCE administration. Insulin sensitivity derived from an OGTT in response to 12 weeks of salsalate or PCE administration. Ovulation rates documented by serum progesterone in response to 12 weeks of salsalate or PCE administration
Detailed description:
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
3-year period.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
General Inclusion Criteria:
- Acceptable health based on interview, medical history, physical examination, and lab
tests
- Ability to comply with the requirements of the study
- Ability and willingness to provide signed, witnessed informed consent
Inclusion Criteria for PCOS:
- Between the ages of 18-40 years
- Body mass index between 18 and 25, or between 30 and 40
- Less than or equal to 8 periods annually
- An elevated serum androgen level or skin manifestations of androgen excess
- Normal thyroid function tests and normal prolactin level
- Exclusion of late-onset adrenal hyperplasia
Inclusion Criteria for Ovulatory Controls:
- Between the ages of 18-40 years
- Body mass index between 18 and 25, or between 30 and 40
- Normal regular monthly periods
- No clinical evidence of androgen excess
- No evidence of polycystic ovaries on ultrasound
Exclusion Criteria:
- Diabetes mellitus
- Clinically significant pulmonary, cardiac ,renal, hepatic, neurologic, psychiatric,
infectious, and malignant disease
- High blood pressure
- Current or recent (within 6 weeks prior to study entry) injection of any drugs known
or suspected to affect reproductive function including oral contraceptives,
metformin, thiazolidinediones, glucocorticoids, GnRH-agonists, or anti-androgens
(spironolactone, flutamide, etc)
- Documented or suspected history of use of recent (within one year) illicit drug abuse
or alcoholism
- Tobacco smoking if salsalate or PCE will be administered
- Ingestion of any investigational drugs within 4 weeks prior to study onset
- Pregnancy or lactation (less than or equal to 6 weeks postpartum)
Locations and Contacts
Frank González, M.D., Phone: (317) 948-7064, Email: gonzalef@iupui.edu
Indiana University Hospital, Indianapolis, Indiana 46202, United States; Recruiting Frank González, M.D., Phone: 317-948-7064, Email: gonzalef@iupui.edu Frank González, M.D., Principal Investigator
Additional Information
Indiana University Reproductive Endocrine and Inflammation Research Program
Starting date: February 2012
Last updated: March 17, 2015
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