* NAFLD (Non-alcoholic fatty liver disease) has become the most common cause of liver disease in Western countries (hepatic manifestation of insulin resistance); * NAFLD represents a cardiovascular risk factor; * Lifestyle modification(weight loss)is the effective medical treatment recommended for NASH (Non-alcoholic Steatohepatitis); * Ezetimibe could represent a novel safe treatment for NAFLD (Patel 2006. Here the investigators propose a Randomized Controlled Pilot Trial to evaluate the addictive effect of ezetimibe on liver histology, biochemical and sonographic parameters in a small (n.40) number of NASH patients randomized for 12 months in two arms: lifestyle vs lifestyle+ezetimibe.
to evaluate the addictive effect of ezetimibe on liver histology, biochemical and sonographic parameters in a small (n.40) number of NASH patients randomized for 12 months in two arms: lifestyle vs lifestyle+ezetimibe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Ezetimibe tablets
lifestyle
Dipartimento Biomedico di Medicina Interna e Specialistica Di.Bi.M.I.S.
Palermo, Italy, Italy
HISTOLOGICAL IMPROVEMENT IN THE SEVERITY OF NASH
1. either improvement in NAS by at least 2 points spread across at least 2 of the NAS components or post-treatment NAS of 3 points or less; 2. at least 1 point improvement in the score for ballooning degeneration; 3. no worsening of the fibrosis score.
Time frame: 52 WEEKS
Changes in individual components of NAS score
Changes in: 1. steatosis, lobular inflammation and hepatocellular balloonin; 2. fibrosis; 3. serum aminotransferase levels 4. anthropometric measures, visceral adiposity index (VAI), insulin resistence, lipid profile and liver elastometry.
Time frame: 6 weeks, 24 weeks, 52 weeks
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