Effect of Spironolactone and Vitamin E in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)

Aristotle University Of Thessaloniki

Status and phase

Completed

Phase 2

Conditions

Fatty Liver

Steatohepatitis

Treatments

Drug: Spironolactone/Vitamin E

Study type

Interventional

Funder types

Other

Identifiers

NCT01147523

PolyzosKountouras

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Bright liver on ultrasound imaging and increased liver function tests for at least 6 months before liver biopsy
Biopsy-proven NAFLD (either NAFL or NASH) according to NAFLD Activity Score (NAS)

Exclusion criteria

Ethanol consumption more than 20 g/day
Known intolerance to spironolactone or vitamin E
History of liver disease (chronic viral hepatitis, autoimmune hepatitis, drug-induced liver disease, primary biliary cirrhosis, hemochromatosis, Wilson's disease and α1-antitrypsin deficiency)
Previous exposure to hepatotoxic drugs
Spironolactone or vitamin E administration within one year before screening
Type I Diabetes Mellitus
Pancreatitis
Uncontrolled hypothyroidism or hyperthyroidism
Adrenal Insufficiency
Renal Failure
Cancer
Pregnancy

Exclusion criteria were generally the same as those proposed for PIVENS trial design with two modifications: a) known intolerance to spironolactone as an exclusion criterion and b) the inclusion of patients with T2DM not receiving thiazolidinediones or insulin.