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Evaluation of Oral Lipid Ingestion in Relation to Ovarian Androgen Secretion in Polycystic Ovary Syndrome (PCOS) (ELI-ROAS)

This study has been terminated.
(The PI left Indiana University. The findings served as preliminary data for a recently awarded NIH R01 grant.)
Sponsor:
Information provided by (Responsible Party):
Frank Gonzalez, Indiana University
ClinicalTrials.gov Identifier:
NCT01489319
First received: December 6, 2011
Last updated: February 8, 2017
Last verified: February 2017

December 6, 2011
February 8, 2017
February 2012
June 2015   (Final data collection date for primary 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. [ Time Frame: 3 years ]
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).
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. [ Time Frame: 2 years ]
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).
Complete list of historical versions of study NCT01489319 on ClinicalTrials.gov Archive Site
  • White blood cell NFkappaB activation following oral lipid ingestion in response to 12 weeks of salsalate or PCE administration. [ Time Frame: 3 years ]
    This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity.
  • Ovarian androgen secretion following HCG administration in response to 12 weeks of salsalate or PCE administration. [ Time Frame: 3 years ]
    This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity.
  • Body composition status measured by DEXA in response to 12 weeks of salsalate or PCE administration. [ Time Frame: 3 years ]
    This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity.
  • Insulin sensitivity derived from an OGTT in response to 12 weeks of salsalate or PCE administration. [ Time Frame: 3 years ]
    This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity.
  • Ovulation rates documented by serum progesterone in response to 12 weeks of salsalate or PCE administration [ Time Frame: 3 years ]
    This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity.
  • White blood cell NFkappaB activation following oral lipid ingestion in response to 12 weeks of salsalate or PCE administration. [ Time Frame: 2 years ]
    This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity.
  • Ovarian androgen secretion following HCG administration in response to 12 weeks of salsalate or PCE administration. [ Time Frame: 2 years ]
    This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity.
  • Body composition status measured by DEXA in response to 12 weeks of salsalate or PCE administration. [ Time Frame: 2 years ]
    This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity.
  • Insulin sensitivity derived from an OGTT in response to 12 weeks of salsalate or PCE administration. [ Time Frame: 2 years ]
    This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity.
  • Ovulation rates documented by serum progesterone in response to 12 weeks of salsalate or PCE administration [ Time Frame: 2 years ]
    This outcome will be assessed in a subset of normal weight women with PCOS who have either normal (n=4) or increased (n=4) abdominal adiposity.
Not Provided
Not Provided
 
Evaluation of Oral Lipid Ingestion in Relation to Ovarian Androgen Secretion in Polycystic Ovary Syndrome (PCOS)
Evaluation of the Ovarian Dynamic Response and the Inflammatory Response to Oral Lipid Challenge in Relation to Body Composition in Polycystic Ovary Syndrome
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Basic Science
Polycystic Ovary Syndrome
  • Drug: Salsalate
    4 out of 10 subjects will receive salsalate 2.0 gm twice a day for 12 weeks; 4 out of 10 subjects will receive PCE 200 mg containing 20% resveratrol twice a day for 12 weeks.
  • Drug: Salsalate
    4 out of the 10 subjects will receive salsalate 2.0 gm twice a day for 12 weeks; 4 out of 10 subjects will receive PCE 200 mg containing 20% resveratrol twice a day for 12 weeks.
  • Experimental: Nl Wt PCOS - Nl Abdominal Adiposity
    10 normal weight women with PCOS who have normal abdominal adiposity established by DEXA
    Intervention: Drug: Salsalate
  • Experimental: Nl Wt PCOS - Increased Abdominal Adiposity
    10 normal weight women with PCOS who have increased abdominal adiposity established by DEXA
    Intervention: Drug: Salsalate
  • No Intervention: Obese PCOS
    10 obese women with PCOS
  • No Intervention: Nl Wt Controls - Nl Abdominal Adiposity
    10 normal weight ovulatory women serving as controls who have normal abdominal adiposity established by DEXA
  • No Intervention: Nl Wt Controls - Increased Abdominal Adiposity
    10 normal weight ovulatory women serving as controls who have increased abdominal adiposity established by DEXA
  • No Intervention: Obese Controls
    10 obese ovulatory women serving as controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
47
June 2015
June 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01489319
IU-PCOS-0112
No
Studies a U.S. FDA-regulated Drug Product: Yes
Not Provided
Not Provided
Frank Gonzalez, Indiana University
Indiana University
Not Provided
Principal Investigator: Frank González, M.D. Indiana University
Indiana University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP