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

Polycystic Ovary Syndrome Clinical Trial

— ELI-ROAS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01489319
• Other study ID #: IU-PCOS-0112
• Status: Terminated
• Phase: Phase 1
• First received: December 6, 2011
• Last updated: February 8, 2017
• Start date: February 2012
• Est. completion date: June 2015

Study information

• Verified date: February 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3 years
Secondary	White blood cell NFkappaB activation following oral lipid ingestion in response to 12 weeks of salsalate or PCE administration.	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.	3 years
Secondary	Ovarian androgen secretion following HCG administration in response to 12 weeks of salsalate or PCE administration.	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.	3 years
Secondary	Body composition status measured by DEXA in response to 12 weeks of salsalate or PCE administration.	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.	3 years
Secondary	Insulin sensitivity derived from an OGTT in response to 12 weeks of salsalate or PCE administration.	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.	3 years
Secondary	Ovulation rates documented by serum progesterone in response to 12 weeks of salsalate or PCE administration	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.	3 years