•Non-alcoholic Steatohepatitis (NASH)
Conditions
Keywords
•Non-alcoholic Steatohepatitis (NASH)
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.
Interventions
DRUGEzetimibe
Ezetimibe tablets
BEHAVIORALLifestyle
lifestyle
Sponsors
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame |
|---|---|
| Changes in the prevalence and severity of metabolic syndrome and the cardiovascular risk profile (Framingham calculator) | 52 weeks |
Countries
Italy
Outcome results
None listed