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Polycystic Ovary SyndromePhase 1ELI-ROASNCT01489319

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

A Phase 1 study testing Salsalate in people with Polycystic Ovary Syndrome, run by Indiana University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Salsalate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteUnited States
Study dates
Feb 2012to Jun 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University Hospital

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
Salsalate
Keywords
inflammation, body composition, hyperandrogenism, insulin resistance
Medical subject headings
Polycystic Ovary Syndrome, Inflammation, Hyperandrogenism, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • SalsalateDrug

    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.

Study groups in NCT01489319
Study groupRoleWhat they receive
Nl Wt PCOS - Nl Abdominal AdiposityExperimental10 normal weight women with PCOS who have normal abdominal adiposity established by DEXA
Receives: Drug: Salsalate
Nl Wt PCOS - Increased Abdominal AdiposityExperimental10 normal weight women with PCOS who have increased abdominal adiposity established by DEXA
Receives: Drug: Salsalate
Obese PCOSNo intervention10 obese women with PCOS
Nl Wt Controls - Nl Abdominal AdiposityNo intervention10 normal weight ovulatory women serving as controls who have normal abdominal adiposity established by DEXA
Nl Wt Controls - Increased Abdominal AdiposityNo intervention10 normal weight ovulatory women serving as controls who have increased abdominal adiposity established by DEXA
Obese ControlsNo intervention10 obese ovulatory women serving as controls

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 3 years

Secondary outcomes (5)

  1. 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.

    Measured: 3 years

  2. 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.

    Measured: 3 years

  3. 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.

    Measured: 3 years

  4. 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.

    Measured: 3 years

  5. 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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completionJun 2015
  4. Study completionJun 2015

Why it stopped: The PI left Indiana University. The findings served as preliminary data for a recently awarded NIH R01 grant.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01489319
Sponsor's protocol ID
IU-PCOS-0112
Acronym
ELI-ROAS
Status last verified
Feb 2017
First submitted
6 Dec 2011
Last updated
10 Feb 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes

Publications

  • 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.

    PubMed 32325487

  • 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.

    PubMed 32140727

  • 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.

    PubMed 30590569

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Salsalate in people with Polycystic Ovary Syndrome, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The PI left Indiana University. The findings served as preliminary data for a recently awarded NIH R01 grant.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01489319, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.

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