Polycystic ovary syndrome (PCOS) is associated with NASH severity and advanced fibrosis.
Monika Sarkar, Norah Terrault, Wesley Chan...
https://pubmed.ncbi.nlm.nih.gov/31627243Actively Recruiting
Led by University of California, San Francisco · Updated on 2026-04-13
150
Participants Needed
2
Research Sites
N/A
Total Duration
U
University of California, San Francisco
Lead Sponsor
D
Duke University
Collaborating Sponsor
Researchers are studying how androgens, a type of sex hormone, may influence nonalcoholic fatty liver disease (NAFLD) in young women, especially those with polycystic ovary syndrome (PCOS). Women with PCOS often have high androgen levels and a higher risk of NAFLD, which can cause liver damage like inflammation or scarring. This observational study aims to compare changes in NAFLD over time between young women with and without PCOS to understand these effects better. The study will follow 150 reproductive-aged women diagnosed with metabolic associated steatohepatitis (MASH), including 125 women with PCOS and 25 without PCOS. Participants will be grouped based on their PCOS status and androgen levels, including those with hyperandrogenism, non-hyperandrogenism, and no PCOS. The research team will assess the relationship between androgen levels, liver injury, visceral fat, and lipid metabolism in these groups. Participants will be monitored over three years, with evaluations including liver stiffness measurements and assessments of visceral adipose tissue at the start and follow-up visits. The study will collect data on liver health progression and fat distribution to explore the connection between androgens and liver disease severity. This research is supported by the National Institutes of Health and conducted by experts at the University of California, San Francisco, and Duke University.
CONDITIONS
Androgens and NAFLD Longitudinal Cohort Study
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants are followed over time to observe liver stiffness changes and the relationship between androgens, visceral fat, and liver disease progression.
Periodic visits over 3 years
Total: 2 locations
1
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Duke University
Durham, North Carolina, United States, 27708
Not Yet Recruiting
L
Lily C Carbullido, B.S.
J
Jasmine Gamez
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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