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
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Ezetimibe tablets plus lifestyle
Active Comparator: lifestyle
- HISTOLOGICAL IMPROVEMENT IN THE SEVERITY OF NASH [ Time Frame: 52 WEEKS ]
- 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;
- at least 1 point improvement in the score for ballooning degeneration;
- no worsening of the fibrosis score.
- Changes in individual components of NAS score [ Time Frame: 6 weeks, 24 weeks, 52 weeks ]
- steatosis, lobular inflammation and hepatocellular balloonin;
- serum aminotransferase levels
- anthropometric measures, visceral adiposity index (VAI), insulin resistence, lipid profile and liver elastometry.
- Changes in the prevalence and severity of metabolic syndrome and the cardiovascular risk profile (Framingham calculator) [ Time Frame: 52 weeks ]
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
|Dipartimento Biomedico di Medicina Interna e Specialistica Di.Bi.M.I.S.|
|Palermo, Italy, 90127|
|Principal Investigator:||Maurizio Averna, Professor||Università degli studi di Palermo|