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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aristotle University Of Thessaloniki
• Treatments: alpha-Tocopherol; Spironolactone; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

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.