Clinical trial NCT01950884: Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis
Official title: A Randomised Controlled Trial of Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: •Non-alcoholic Steatohepatitis (NASH)
Keywords: •Non-alcoholic Steatohepatitis (NASH)
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2013-09-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 1.Patients older 18 years
* 2.Histological diagnosis of possible or definite NASH, according to Kleiner scorw, within 6 months before randomization -

Exclusion Criteria:

* 1)Average alcohol consumption \> 20 g per day in women and \> 30 g per day in men
* 2)other causes of chronic liver disease 3) History of or planned gastrointestinal bypass or any additional bariatric surgery/intervention 4)Hepatic cirrhosis with Child-Pugh score of B or C, and/or concomitant HCC 5)Recent(within 6 months) or concomitant use of agents known to cause hepatic steatosis 7)Recent(within 6 months)change in dose/regimen or first treatment with vitamin E, C, betaine, s-adenosylmethionine, ursodeoxycholate, sylimarin, fibrate, statin, pentoxyfilline, angiotensin II inhibitors, orlistat, sibutramine 8)Ongoing or recent therapy (within 6 months) with vitamin D or with medications known to affect vitamin D3 metabolism 9)Any additional condition that might interfere with optimal partecipation in the study, according to Investigators opinion; 10)Be pregnant or breastfeeding.

Primary outcomes:
measure: HISTOLOGICAL IMPROVEMENT IN THE SEVERITY OF NASH
timeFrame: 52 WEEKS
Secondary outcomes:
measure: Changes in individual components of NAS score
timeFrame: 6 weeks, 24 weeks, 52 weeks
Other outcomes:
measure: Changes in the prevalence and severity of metabolic syndrome and the cardiovascular risk profile (Framingham calculator)
timeFrame: 52 weeks
Locations:
city: Palermo
country: Italy
facility: Dipartimento Biomedico di Medicina Interna e Specialistica Di.Bi.M.I.S.
Study officials:
affiliation: University of Palermo
name: Maurizio Averna, Professor
role: PRINCIPAL_INVESTIGATOR
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