Status:
COMPLETED
Effect of Spironolactone and Vitamin E in Patients With Nonalcoholic Fatty Liver Disease
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Fatty Liver
Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed 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, detec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01147523
Start Date
January 1 2010
End Date
December 1 2011
Last Update
January 20 2012
Active Locations (1)
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1
Second Medical Clinic, Medical School, Aristotle University of Thessaloniki, Ippokration Hospital
Thessaloniki, Thessaloniki, Greece, 54642