The aim of this study was to evaluate the efficacy of acarbose (alafa glicosidase inhibitor) and ezetimibe (NPC1L1 inhibitor, a lipid-lowering agent) as new therapeutic approaches for treatment of non-alcoholic fatty liver disease. This study was the second phase of a double blind randomized clinical trial. A total of 62 ultrasonograghic proven NAFLD patient with elevated liver enzymes assigned into 2 groups. The patients with concomittent liver disease, chronic hepatitis or alcohol consumption more than 20 gr per day excluded from this study. In acarbose group patients received 50 mg acarbose 3 times per day and the ezetimibe group received 10 mg ezetimibe per day. The duration of study was two months. Liver enzymes, insulin resistance index, serum lipids, BMI and CRP were measured before and after administration of the drugs and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109197590N1
Registration date:2011-12-23, 1390/10/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-23, 1390/10/02
Registrant information
Name
Foroogh Alborzi Avanaki
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 2932
Email address
foalborzi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of ezetimibe and acarbose on biochemical indices in patient with nonalcoholic fatty liver disease
Public title
The effect of ezetimibe and acarbose in treatment of non alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- the patients diagnosed by means of ultrasound (Bright liver pattern with liver kidney contrast); 2-ALT more than 40 in men and more than 31 in women; 3-Age above18. Exclusion criteria: 1-Type1 or 2 diabetes mellitus; 2-Positive serology for hepatitis; 3-Alcohol consumption more than 20gr per day; 4-History of renal or liver disease; 5-Using drugs like steroids or drugs that influence energy metabolism, intestinal transit, substrate metabolism.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Science, Bahonar blvd