Androgens and Fatty Liver Disease in Young Women

This observational study wants to understand how androgens (male hormones that women also have) might affect nonalcoholic fatty liver disease (NAFLD) in young women. NAFLD is when fat builds up in the liver, which can lead to damage like inflammation or scarring. Researchers are especially interested in young women with polycystic ovary syndrome (PCOS), as they often have high androgen levels and a higher risk of NAFLD. The study will follow women with and without PCOS to see how their liver stiffness changes over three years and how fat around their organs (visceral adipose tissue or VAT) is linked to the severity of a more advanced liver disease called MASH (metabolic associated steatohepatitis, formerly NASH). This study is for women aged 18 to 42 who have MASH and/or PCOS, or neither. You cannot join if you drink a lot of alcohol, are pregnant, have other causes of liver fat, or have had recent significant weight loss. The study aims to enroll 150 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information over time without giving any specific treatments. It aims to include 150 women.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three years to measure changes in liver stiffness.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06124261

Androgens and NAFLD Longitudinal Cohort Study

Recruiting
Not specifiedAges 18–42Observational
University of California, San Francisco
~150 participants
Updated 2026-04-13 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Liver Stiffness Change
Measured over from baseline to Year 3 follow- up.
+1 more outcome measured
PCOS
NAFLD
NASH

NCT06124261

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Duke University

    Durham, North Carolinastudy coordinator listed

    Not yet recruiting

  • University of California San Francisco

    San Francisco, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Monika A Sarkar, M.D., M.A.S · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
  • Amreen Dinani, MD · PRINCIPAL_INVESTIGATOR · Duke University

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Liver Stiffness Changefrom baseline to Year 3 follow- up.

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

  • Visceral Adipose Tissue (VAT) association to MASH severityat baseline

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