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Evaluation of the Ovarian Dynamic Response and the Inflammatory Response to Oral Lipid Challenge in Relation to Body Composition in Polycystic Ovary Syndrome


N/A
18 Years
40 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome

Thank you

Trial Information

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
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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

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.

Outcome Description:

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).

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Frank González, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Food and Drug Administration

Study ID:

IU-PCOS-0112

NCT ID:

NCT01489319

Start Date:

February 2012

Completion Date:

January 2015

Related Keywords:

  • Polycystic Ovary Syndrome
  • inflammation
  • body composition
  • hyperandrogenism
  • insulin resistance
  • Polycystic Ovary Syndrome

Name

Location
Indiana University Hospital Indianapolis, Indiana  46202