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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nl Wt PCOS - Nl Abdominal Adiposity

10 normal weight women with PCOS who have normal abdominal adiposity established by DEXA

Group Type EXPERIMENTAL

Salsalate

Intervention Type DRUG

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.

Nl Wt PCOS - Increased Abdominal Adiposity

10 normal weight women with PCOS who have increased abdominal adiposity established by DEXA

Group Type EXPERIMENTAL

Salsalate

Intervention Type DRUG

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.

Obese PCOS

10 obese women with PCOS

Group Type NO_INTERVENTION

No interventions assigned to this group

Nl Wt Controls - Nl Abdominal Adiposity

10 normal weight ovulatory women serving as controls who have normal abdominal adiposity established by DEXA

Group Type NO_INTERVENTION

No interventions assigned to this group

Nl Wt Controls - Increased Abdominal Adiposity

10 normal weight ovulatory women serving as controls who have increased abdominal adiposity established by DEXA

Group Type NO_INTERVENTION

No interventions assigned to this group

Obese Controls

10 obese ovulatory women serving as controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

* 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

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes