Androgens and NAFLD Longitudinal Cohort Study

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06124261
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 42 Years
Healthy Volunteers
Not accepted

Study Details

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

Key Dates

Start date
Jan 22, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: MASLD and PCOS hyperandrogenism
    Patients with MASLD and PCOS with the phenotype of hyperandrogenism
  • Arm: MASLD and PCOS non-hyperandrogenism
    Patients with MASLD and PCOS with the phenotype of non-hyperandrogenism
  • Arm: MASLD and no-PCOS
    Patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and no PCOS

Primary Outcome Measure

Liver Stiffness Change [ Time Frame: from baseline to Year 3 follow- up. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143
Lily C Carbullido, B.S.
[email protected]
415-502-3725
Jasmine Gamez, B.S.
[email protected]
415-353-9240
Duke UniversityDurhamNorth Carolina27708
Linda Perry, R.N.
[email protected]

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