Spironolactone Therapy In Young Women With NASH

Exclusion Criteria

• •1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
• •2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
• •3. Uncontrolled diabetes (HbA1c 9.5% or higher within 60 days prior to enrollment)
• •4. Routine alcohol consumption \>7 drinks per week during the preceding 3 months prior to baseline liver biopsy.
• •5. Other forms of chronic liver disease including hepatitis B virus infection (hepatitis B surface antigen positive), chronic hepatitis C virus (HCV) infection (HCV Ab and HCV ribonucleic acid positive), autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, and autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitrypsin deficiency, based on medical history and/or centralized review of liver histology
• •6. Any prior or upcoming weight reduction surgery (e.g., Roux-en-Y or gastric bypass)
• •7. HIV infection
• •8. Receipt of drugs associated with NAFLD (i.e. amiodarone, methotrexate, systemic glucocorticoids, tamoxifen, anabolic steroids, valproic acid) for more than 4 weeks prior to baseline or between baseline and follow-up biopsies
• •9. Perimenopausal status (defined as within 3 years of self-reported menopause) due to unstable hormonal levels during that time
• •10. Renal impairment defined as glomerular filtration rate \<45 ml/min/1.73m or potassium levels \> 5.0 mmol/L due to the diuretic effect of spironolactone
• •11. Participation in another clinical trial of an investigational drug or device
• •12. History of medication non adherence as noted upon chart review or patient report of difficulty with medication adherence
• •13. Androgen receptor antagonist use (i.e. flutamine, spironolactone or flutamide) for more than 3 months within one year prior to baseline biopsy
• •14. Eplerenone use as this is a diuretic that also blocks the aldosterone receptor and could compound side effects
• •15. Cirrhosis on baseline biopsy as this condition leads to altered sex hormone metabolism
• •16. Unstable dosing (i.e. dose increase, intermittent use, or initiation) of Vitamin E anytime during the 3 months prior to baseline biopsy
• •17. Significant weight loss (at least 10% decrease in body weight) over preceding 3 months prior to baseline biopsy
• •18. Contraindication to MRI scanning (e.g. presence of permanent pacemakers, implanted cardiac devices, etc.)