Finding studies
Finding studies
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Lead
University of California, San Francisco
This is a single center, double-blind, placebo-controlled, randomized, (2:1) parallel group pilot clinical trial of spironolactone in women with biopsy-proven NASH receiving 6 or 12 months of spironolactone or placebo. 30 women are targeted for enrollment. Each participant will be administered a single dose of spironolactone or placebo once daily for a total of 6 or 12 months. In person evaluations will take place at Month 1, 3, 6, 9, and 12. There will be a telephone follow up visit within 3 months of end of treatment (up to Month 9 or 15). This is a pilot clinical trial that is largely feasibility focused. Study outcomes will include * Change in liver stiffness on Magnetic Resonance Elastography (MRE) * Change in hepatic steatosis by Magnetic Resonance Proton Density Fat Fraction (PDFF) * Change in visceral adipose tissue (VAT) volume by Magnetic Resonance Imaging (MRI) * Change in NASH histology as assessed by the continuous NAFLD activity score (NAS), which measures different components of NASH on liver biopsy. * Biochemical endpoints: serum lipids \& HOMA-IR * Feasibility outcomes including Rates (and reasons) for the following: a) % women that decline/women contacted for study inclusion (i.e. need for a second liver biopsy, concern regarding randomization to placebo) b) % women enrolled/women screened (i.e. exclusion criteria too narrow), c) study dropout (i.e. medication side effects, too frequent study visits, and/or phlebotomy)
Age
18–45
Sex
FEMALE
Healthy volunteers
Not accepted
