Considering the importance of treating fatty liver disease, present study will be done to compare the therapeutic effects of pioglitazone with metformin. 80 nonalcoholic steatohepatitis (NASH) patients, with elevated liver enzymes, will be enrolled in the study after confirmation of fatty liver using ultrasonography. Patients will be divided into two 40-member groups in a randomized manner with Block Randomization. For treatment of fatty liver, metformin or Pioglitazone are prescribed for 4 months. Body weight, liver enzymes, Low density lipoprotein (LDL), High density lipoprotein (HDL), Triglyceride (TG), Total cholesterol (Chlo) and Fasting blood sugar (FBS) are evaluated before intervention, 2 months later and after finishing study in both groups. Also HOMA index (Homeostatic model assessment) index and Adiponectin are investigated before intervention and after finishing study in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105026361N1
Registration date:2011-11-16, 1390/08/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-11-16, 1390/08/25
Registrant information
Name
Effat Taherkhani
Name of organization / entity
Kashan University Medical Siences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 5586 6211
Email address
razavizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences and Health Services
Expected recruitment start date
2011-03-06, 1389/12/15
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the treatment effect of Pioglitazone with Metformin in patients with Non Alcoholic SteatoHepatitis (NASH)
Public title
Comparison the treatment effect of Pioglithazone with Metformin in patients with
Non Alcoholic SteatoHepatitis (NASH)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with fatty liver disease based on sonography that have Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) more than normal (more than 40). Exclusion criteria: Alcohol consumption; drug induced hepatitis; use of some drugs (corticosteroids, statins); Diabetes mellitus; Chronic viral hepatitis (B,C); Autoimmune hepatitis; Wilson disease; Hemochromatosis; Ischemic heart disease; Heart failure; Liver failure; liver mass; Pregnancy.
Age
From 21 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences and Health Services
Street address
Medical college, Ghotb Ravandi boulevard
City
Kashan
Postal code
8715981151
Approval date
2011-01-10, 1389/10/20
Ethics committee reference number
2851/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Fatty liver
ICD-10 code
K76.0
ICD-10 code description
fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
FBS
Timepoint
Before intervention, two months after intervention and end of intervention (four months after intervention)
Method of measurement
Device photometry
2
Description
TG
Timepoint
Before intervention, two months after intervention and end of intervention (four months after intervention)
Method of measurement
Device photometry
3
Description
Chlo
Timepoint
Before intervention, two months after intervention and end of intervention (four months after intervention)
Method of measurement
Device photometry
4
Description
HDL
Timepoint
Before intervention, two months after intervention and end of intervention (four months after intervention)
Method of measurement
Device photometry
5
Description
LDL
Timepoint
Before intervention, two months after intervention and end of intervention (four months after intervention)
Method of measurement
Device photometry
6
Description
AST
Timepoint
Before intervention, two months after intervention and end of intervention (four months after intervention)
Method of measurement
Device photometry
7
Description
ALT
Timepoint
Before intervention, two months after intervention and end of intervention (four months after intervention)
Method of measurement
Device photometry
8
Description
Alkp
Timepoint
Before intervention, two months after intervention and end of intervention (four months after intervention)
Method of measurement
Device photometry
9
Description
Body weight
Timepoint
Before intervention, two months after intervention and end of intervention (four months after intervention)
Method of measurement
Balance
10
Description
HOMA Index
Timepoint
Before intervention and end of intervention (four months after intervention)