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.
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Androgens and NAFLD Longitudinal Cohort Study
At a glance
Conditions
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.
Study leadership
- Monika A Sarkar, M.D., M.A.S · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
- Amreen Dinani, MD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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Inclusion
Exclusion
What this trial measures
- 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)