About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Metabolic associated steatohepatitis (MASH) (formerly NASH)
PCOS
Non-PCOS
Disqualifiers
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
Trial population
Our study population includes pre-menopausal women ages 18-42 years, 125 with PCOS and 25 non-PCOS controls, with probable or confirmed metabolic associated steatohepatitis
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Liver Stiffness Change
Mean change in liver stiffness (kPA) on magnetic resonance elastography (MRE)
Visceral Adipose Tissue (VAT) association to MASH severity
VAT volume (cm3) will be determined on magnetic resonance electrography (MRE)
Secondary outcomes
Liver stiffness severity
Severity of liver stiffness will be determined on magnetic resonance electrography (MRE)
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
Duke University
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator