Fatty Liver Clinical Trial
Official title:
The Effect of Spironolactone and Vitamin E Versus Vitamin E on Serum Adipocytokines Levels in Patients With Biopsy-proven Nonalcoholic Fatty Liver Disease-A Phase II Study
The primary aim of the study is the effect of spironolactone and vitamin E versus vitamin E on serum levels of adipokines 52 weeks post-treatment.
Unlike other chronic liver diseases (e.g., hepatitis C), there are no effective treatment
strategy for NAFLD. Currently, the management of NAFLD includes modification of underlying
risk factors, detection of patients that have progressed to cirrhosis, management of
cirrhosis-related morbidity and transplantation in patients with end-stage liver disease.
Diet, exercise, bariatric surgery and pharmacologic treatment, including weight loss agents,
insulin sensitizers, lipid-lowering agents, ursodeoxycholic acid and vitamin E have been
investigated with some promising results.
The renin-angiotensin-aldosterone system (RAAS) has been implicated in the pathogenesis of
insulin resistance (IR) and nonalcoholic fatty liver disease (NAFLD). Recently, low-dose
(25-50 mg/day) aldosterone antagonists in patients with heart failure diminish mortality,
possibly by reducing cardiac and vascular fibrosis. Moreover, the beneficial effect of
spironolactone in a mouse model with diet-induced diabetes and NAFLD has been reported.
However, to our knowledge, the role of spironolactone in NAFLD patients has not been
investigated yet.
The primary aim of the study is the effect of spironolactone and vitamin E versus vitamin E
on serum levels of adipokines 52 weeks post-treatment.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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