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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Spironolactone, tablets, 25 mg daily plus Vitamin E, capsules, 400 mg daily, for 52 weeks
Second Medical Clinic, Medical School, Aristotle University of Thessaloniki, Ippokration Hospital
Thessaloniki, Thessaloniki, Greece
Serum adipocytokines levels
Adiponectin; visfatin; leptin; resistin; omentin; vaspin; RBP4; TNF-alpha, IL-6; IL-1
Time frame: 52 weeks
Serum homocysteine levels
Homocysteine; vitamin B12; folate
Time frame: 52 weeks
Liver histology
Repeat biopsy, if patients provide their consent
Time frame: 52 weeks
Insulin resistance
Serum insulin; serum glucose; HOMA and QUICKI indexes
Time frame: 52 weeks
Hormonal profile
DHEAS; testosterone; estradiol; TSH; free T4; cortisol (serum levels)
Time frame: 52 weeks
Serum biochemistry
ALT; AST; ggt; Potassium; Sodium; urea; creatinin; cholesterol; triglycerides; HDL; LDL
Time frame: 52 weeks
Reactive Oxygen Metabolites (ROMs)
Serum dROMs leves
Time frame: 52 weeks
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