NCT01489319

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 9, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

3.3 years

First QC Date

December 6, 2011

Last Update Submit

February 8, 2017

Conditions

Polycystic Ovary Syndrome

Keywords

inflammationbody compositionhyperandrogenisminsulin resistance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • White blood cell NFkappaB activation following oral lipid ingestion in response to 12 weeks of salsalate or PCE administration.

    3 years

  • Ovarian androgen secretion following HCG administration in response to 12 weeks of salsalate or PCE administration.

    3 years

  • Body composition status measured by DEXA in response to 12 weeks of salsalate or PCE administration.

    3 years

  • Insulin sensitivity derived from an OGTT in response to 12 weeks of salsalate or PCE administration.

    3 years

  • Ovulation rates documented by serum progesterone in response to 12 weeks of salsalate or PCE administration

    3 years

Study Arms (6)

Nl Wt PCOS - Nl Abdominal Adiposity

EXPERIMENTAL

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

Drug: Salsalate

Nl Wt PCOS - Increased Abdominal Adiposity

EXPERIMENTAL

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

Drug: Salsalate

Obese PCOS

NO INTERVENTION

10 obese women with PCOS

Nl Wt Controls - Nl Abdominal Adiposity

NO INTERVENTION

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

Nl Wt Controls - Increased Abdominal Adiposity

NO INTERVENTION

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

Obese Controls

NO INTERVENTION

10 obese ovulatory women serving as controls

Interventions

SalsalateDRUG

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 - Nl Abdominal Adiposity

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (3)

  • Gonzalez F, Considine RV, Abdelhadi OA, Acton AJ. Lipid-induced mononuclear cell cytokine secretion in the development of metabolic aberration and androgen excess in polycystic ovary syndrome. Hum Reprod. 2020 May 1;35(5):1168-1177. doi: 10.1093/humrep/deaa056.

    PMID: 32325487DERIVED

  • Gonzalez F, Considine RV, Abdelhadi OA, Acton AJ. Inflammation Triggered by Saturated Fat Ingestion Is Linked to Insulin Resistance and Hyperandrogenism in Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2020 Jun 1;105(6):e2152-67. doi: 10.1210/clinem/dgaa108.

    PMID: 32140727DERIVED

  • Gonzalez F, Considine RV, Abdelhadi OA, Acton AJ. Saturated Fat Ingestion Promotes Lipopolysaccharide-Mediated Inflammation and Insulin Resistance in Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2019 Mar 1;104(3):934-946. doi: 10.1210/jc.2018-01143.

    PMID: 30590569DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeInflammationHyperandrogenismInsulin Resistance

Interventions

salicylsalicylic acid

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Frank González, M.D.

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Director, Division of Reproductive Endocrinology and Infertility

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 9, 2011

Study Start

February 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

US(1)