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.
•Non-alcoholic Steatohepatitis (NASH)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomised Controlled Trial of Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis|
- HISTOLOGICAL IMPROVEMENT IN THE SEVERITY OF NASH [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Ezetimibe tablets plus lifestyle
Other Name: EzetimibeBehavioral: Lifestyle
Other Name: lifestyle
Active Comparator: lifestyle
Other Name: lifestyle
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|