Investigating how androgens affect liver health in young women
Androgens and Nonalcoholic Fatty Liver Disease (NAFLD) In Reproductive-Aged Women With and Without Polycystic Ovary Syndrome (PCOS)
This study is trying to see how hormones called androgens affect liver health in young women, especially those with polycystic ovary syndrome, by comparing liver disease progression between women with and without this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | Female |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT06124261 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the impact of androgens on nonalcoholic fatty liver disease (NAFLD) in young women, particularly focusing on those with polycystic ovary syndrome (PCOS). Researchers will compare the progression of NAFLD over time between young women with PCOS and those without. The study hypothesizes that androgens contribute to liver injury and the progression of NAFLD/NASH through mechanisms involving lipid metabolism and visceral fat activity. The research is funded by the National Institutes of Health and involves collaboration between the University of California, San Francisco, and Duke University.
Who should consider this trial
Good fit: Ideal candidates include young women diagnosed with PCOS or those without PCOS who may be at risk for NAFLD.
Not a fit: Patients with high alcohol consumption, current pregnancy, or significant recent weight loss may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of liver health in young women with PCOS.
How similar studies have performed: While the specific approach of this study is novel, existing data suggest that androgens have significant effects on liver health in women, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Metabolic associated steatohepatitis (MASH) (formerly NASH) * PCOS * Non-PCOS Exclusion Criteria: * 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
Where this trial is running
San Francisco, California and 1 other locations
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Monika A Sarkar, M.D., M.A.S — University of California, San Francisco
- Study coordinator: Lily C Carbullido, B.S.
- Email: myliverhealth@ucsf.edu
- Phone: 415-502-3725
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.