Status:

RECRUITING

Androgens and NAFLD Longitudinal Cohort Study

Lead Sponsor:

University of California, San Francisco

Collaborating Sponsors:

Duke University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

PCOS

NAFLD

Eligibility:

FEMALE

18-42 years

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 caus...

Detailed Description

The studies central hypothesis is that androgens promote liver injury and NAFLD/NASH progression in PCOS, which occurs through aberrant lipid activity (including lipotoxicity and dysregulated de novo ...

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

Key Trial Info

Start Date :

January 22 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2028

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT06124261

Start Date

January 22 2024

End Date

December 1 2028

Last Update

March 21 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

University of California San Francisco

San Francisco, California, United States, 94143

2

Duke University

Durham, North Carolina, United States, 27708