Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis

Phase 4

• Conditions: •Non-alcoholic Steatohepatitis (NASH)
• Interventions: Drug: Ezetimibe; Behavioral: Lifestyle

• Registration Number: NCT01950884
• Lead Sponsor: University of Palermo

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.

Study Timeline

• Status Verified: 2013-09
• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-09-23
• Last Update Submitted: 2013-09-23
• Study First Posted: 2013-09-26
• Last Update Posted: 2013-09-26
• Study Start: 2013-10
• Primary Completion: 2014-10
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ezetimibe	Lifestyle	Ezetimibe tablets plus lifestyle
lifestyle	Lifestyle	lifestyle
Ezetimibe	Ezetimibe	Ezetimibe tablets plus lifestyle

Primary Outcome Measures

Name	Time	Method
HISTOLOGICAL IMPROVEMENT IN THE SEVERITY OF NASH	52 WEEKS	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.

Secondary Outcome Measures

Name	Time	Method
Changes in individual components of NAS score	6 weeks, 24 weeks, 52 weeks	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.

Trial Locations

Locations (1)

Dipartimento Biomedico di Medicina Interna e Specialistica Di.Bi.M.I.S.; 🇮🇹 Palermo, Italy