Nonalcoholic fatty liver disease (NAFLD) is a potentially progressive liver disease, leading to cirrhosis in up to 26% of affected patients and rarely hepatocellular carcinoma. Several studies have linked NAFLD to the metabolic syndrome even in non-obese patients with normal glucose tolerance.
Conditions
Interventions
Trade Name: Ezetrol
Product Name: Ezetrol
Pharmaceutical Form: Tablet
INN or Proposed INN: Ezetimibe
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceuti
Sponsors
Dept of Internal Medicine IV, Med Uni Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients with elevated liver enzymes and NAFLD (=33% hepatic steatosis) on liver histology in whom other causes of liver disease have been excluded. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •viral hepatitis (A, B, C) •autoimmune, genetic, cholestatic liver diseases •consumption of >140 grams of alcohol per week •regular exercise training (=3 times per week) before begin of the study •pregnancy and lactation •known hypersensitivity to Ezetimibe •Patients currently taking lipid lowering agents -contraindications to MR-Spectroscopy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary outcome variable: •Reduction of hepatic steatosis ;Secondary Objective: Secondary outcome variables: •Improvement in insulin resistance •Improvement of liver enzymes •Body weight change ;Primary end point(s): Primary outcome variable: •Reduction of hepatic steatosis Secondary outcome variables: •Improvement in insulin resistance •Improvement of liver enzymes •Body weight change | — |
Countries
Austria
Outcome results
None listed