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

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ClinicalTrials.gov Identifier: NCT01950884
Recruitment Status : Unknown
Verified September 2013 by Maurizio R. Averna, University of Palermo.
Recruitment status was:  Enrolling by invitation
First Posted : September 26, 2013
Last Update Posted : September 26, 2013
Sponsor:
Information provided by (Responsible Party):
Maurizio R. Averna, 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.

Condition or disease Intervention/treatment Phase
•Non-alcoholic Steatohepatitis (NASH) Drug: Ezetimibe Behavioral: Lifestyle Phase 4

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  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis
Study Start Date : October 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: Ezetimibe
Ezetimibe tablets plus lifestyle
Drug: Ezetimibe
Ezetimibe tablets

Behavioral: Lifestyle
lifestyle

Active Comparator: lifestyle
lifestyle
Behavioral: Lifestyle
lifestyle




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Changes in the prevalence and severity of metabolic syndrome and the cardiovascular risk profile (Framingham calculator) [ Time Frame: 52 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950884


Locations
Italy
Dipartimento Biomedico di Medicina Interna e Specialistica Di.Bi.M.I.S.
Palermo, Italy, 90127
Sponsors and Collaborators
University of Palermo
Investigators
Principal Investigator: Maurizio Averna, Professor Università degli studi di Palermo

Publications:

Responsible Party: Maurizio R. Averna, MD, University of Palermo
ClinicalTrials.gov Identifier: NCT01950884     History of Changes
Other Study ID Numbers: LISTEN
2013-003465-33 ( EudraCT Number )
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013

Keywords provided by Maurizio R. Averna, University of Palermo:
•Non-alcoholic Steatohepatitis (NASH)

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents