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

September 23, 2013 updated by: Maurizio R. Averna, University of Palermo

A Randomised Controlled Trial of Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis

  • 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90127
        • Dipartimento Biomedico di Medicina Interna e Specialistica Di.Bi.M.I.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ezetimibe
Ezetimibe tablets plus lifestyle
Drug: Ezetimibe
Ezetimibe tablets
Behavioral: Lifestyle
lifestyle
Active Comparator: lifestyle
Behavioral: Lifestyle
lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HISTOLOGICAL IMPROVEMENT IN THE SEVERITY OF NASH
Time Frame: 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.
52 WEEKS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in individual components of NAS score
Time Frame: 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.
6 weeks, 24 weeks, 52 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Changes in the prevalence and severity of metabolic syndrome and the cardiovascular risk profile (Framingham calculator)
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Palermo

Investigators

  • Principal Investigator: Maurizio Averna, Professor, University of Palermo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (Estimate)

September 26, 2013

Study Record Updates

Last Update Posted (Estimate)

September 26, 2013

Last Update Submitted That Met QC Criteria

September 23, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LISTEN
  • 2013-003465-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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