Purpose of this Study
We are doing this study to learn more about how androgens, a type of sex hormone, might affect women who have nonalcoholic fatty liver disease (NAFLD). We want to see if they play a role in how the disease effects women over time, and we also want to see what role these hormones might play in the relationship between NAFLD and polycystic ovary syndrome.
Who Can Participate?
Eligibility
Women ages 18-42 who:
- Are diagnosed with or suspected to have metabolic associated steatohepatitis (MASH) as defined by previous liver biopsy or fibroscan results
- Have or do not have polycystic ovary syndrome
- Do not have intestinal dysfunction, HIV, diabetes, or cancer
- Have not had weight loss surgery or significant weight loss in the past 3 months
- Do not use anabolic steroids or any type of anti-androgen medication
Age Range
18-42
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will:
- Consult with a hepatologist (doctor who specializes in the liver) about lifestyle factors like physical activity, nutrition, substance use, and medical history
- Have a fibroscan (an ultrasound based imaging scan that measures scarring in the liver)
- Have physical exams
- Have a liver MRI to measure the amount of fat around the liver
- Have blood draws
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Androgens and Nonalcoholic Fatty Liver Disease (NAFLD) in Reproductive-Aged Women With and Without Polycystic Ovary Syndrome (PCOS)
Principal Investigator
Ayako
Suzuki
Protocol Number
PRO00113782
Phase
N/A
Enrollment Status
Open to Enrollment