NCT06124261

Brief Summary

The researchers want to learn how androgens, a type of sex hormone, might affect nonalcoholic fatty liver (NAFLD) in young women over time. NAFLD happens when fat builds up in the liver which can cause damage to the liver such as inflammation or scarring. Young women with a condition called polycystic ovary syndrome (PCOS) have a high risk for NAFLD, and they often have high androgen levels too. So the researchers are recruiting young women with PCOS as well as those without PCOS, and will compare changes in NAFLD over time between young women with and without PCOS. This study is funded by the National Institutes of Health

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
31mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress47%
Jan 2024Dec 2028

First Submitted

Initial submission to the registry

November 3, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 22, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.9 years

First QC Date

November 3, 2023

Last Update Submit

April 9, 2026

Conditions

PCOSNAFLDNASH

Keywords

Androgen

Outcome Measures

Primary Outcomes (2)

  • Liver Stiffness Change

    Mean change in liver stiffness (kPA) on magnetic resonance elastography (MRE)

    from baseline to Year 3 follow- up.

  • Visceral Adipose Tissue (VAT) association to MASH severity

    VAT volume (cm3) will be determined on magnetic resonance electrography (MRE)

    at baseline

Secondary Outcomes (1)

  • Liver stiffness severity

    at baseline

Study Arms (3)

MASLD and PCOS hyperandrogenism

Patients with MASLD and PCOS with the phenotype of hyperandrogenism

MASLD and PCOS non-hyperandrogenism

Patients with MASLD and PCOS with the phenotype of non-hyperandrogenism

MASLD and no-PCOS

Patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and no PCOS

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Our study population includes pre-menopausal women ages 18-42 years, 125 with PCOS and 25 non-PCOS controls, with probable or confirmed metabolic associated steatohepatitis

You may qualify if:

  • Metabolic associated steatohepatitis (MASH) (formerly NASH)
  • PCOS
  • Non-PCOS

You may not qualify if:

  • High levels of alcohol use (more than 7 drinks a week)
  • Current pregnancy
  • Other causes of hepatic steatosis
  • Weight loss of more than 10% body weight in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Duke University

Durham, North Carolina, 27708, United States

NOT YET RECRUITING

Related Publications (4)

  • Sarkar M, Terrault N, Chan W, Cedars MI, Huddleston HG, Duwaerts CC, Balitzer D, Gill RM. Polycystic ovary syndrome (PCOS) is associated with NASH severity and advanced fibrosis. Liver Int. 2020 Feb;40(2):355-359. doi: 10.1111/liv.14279. Epub 2019 Nov 12.

    PMID: 31627243BACKGROUND

  • Sarkar MA, Suzuki A, Abdelmalek MF, Yates KP, Wilson LA, Bass NM, Gill R, Cedars M, Terrault N; NASH Clinical Research Network. Testosterone is Associated With Nonalcoholic Steatohepatitis and Fibrosis in Premenopausal Women With NAFLD. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1267-1274.e1. doi: 10.1016/j.cgh.2020.09.045. Epub 2020 Oct 1.

    PMID: 33010412BACKGROUND

  • Sarkar M, Yates K, Suzuki A, Lavine J, Gill R, Ziegler T, Terrault N, Dhindsa S. Low Testosterone Is Associated With Nonalcoholic Steatohepatitis and Fibrosis Severity in Men. Clin Gastroenterol Hepatol. 2021 Feb;19(2):400-402.e2. doi: 10.1016/j.cgh.2019.11.053. Epub 2019 Dec 5.

    PMID: 31812658BACKGROUND

  • Sarkar M, Terrault N, Duwaerts CC, Tien P, Cedars MI, Huddleston H. The Association of Hispanic Ethnicity with Nonalcoholic Fatty Liver Disease in Polycystic Ovary Syndrome. Curr Opin Gynecol Obstet. 2018 Feb 20;1(1):24-33. Epub 2018 Apr 5.

    PMID: 30112518BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and optional liver samples

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Monika A Sarkar, M.D., M.A.S

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Amreen Dinani, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lily C Carbullido, B.S.

CONTACT

415-502-3725myliverhealth@ucsf.edu

Jasmine Gamez

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 9, 2023

Study Start

January 22, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

At present all data collected will be de-identified and shared with only the researchers apart of this study.

Locations

US(2)