This study aimed to investigate the Compare the effects of fenofibrate with pioglitazone treatment of patients with NAFLD, as a clinical trial study. And 90 patients with proven NAFLD by ultrasonography and ALT more than 1.5 to 5 times the normal, BMI between 25 to 29.9 with the written consent referred to the gastroenterology clinic in Vali Asr hospital or private offices to be studied. And weight, blood pressure, BMI, liver function tests, blood glucose, and lipid profiles are analyzed. Both groups will be referred to a dietitian. Then randomly divided into three groups (30 people). The control group will have a daily exercise for at least 30 minutes. The intervention group A will receive fenofibrate capsule 200 mg once daily after a meal and the intervention group B receive pioglitazone tablet 30 mg once daily after a meal . After 12 weeks of starting treatment the above cases, re-evaluated by same person in the same laboratory unit. Information collected will be evaluated and compared. And fenofibrate with pioglitazone impact in the treatment of NAFLD and reducing liver enzymes checked. In this study, reducing the amount of ALT as the primary outcome and improvement of fatty liver was considered as a secondary outcome.
General information
Acronym
Compare
the effects of pioglitazone with fenofibrate in treatment of patients with NAFLD
IRCT registration information
IRCT registration number:IRCT2015120819554N10
Registration date:2016-07-12, 1395/04/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-12, 1395/04/22
Registrant information
Name
Maryam Jameshorani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00989126416972 و 00982433770805
Email address
dr.shirinjameshorani@zumc.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Zanjan University Of Medical Sciences
Expected recruitment start date
2016-07-20, 1395/04/30
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effects of pioglitazone with fenofibrate in treatment of patients with NAFLD
Public title
Compare the effects of pioglitazone with fenofibrate in treatment of patients with NAFLD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with NAFLD on ultrasonography; ALT more than 1.5 to 5 times the normal range; BMI between 25 to 29.9
Exclusion criteria:
Alcoholic hepatitis; systemic or metabolic or inflammatory disease such as diabetes; viral hepatitis; autoimmune hepatitis; secondary fatty liver disease such as drug induced fatty liver disease
Age
From 30 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
Medical School, Zanjan University of Medical Sciences, Karmandan street, Zanjan
City
zanjan
Postal code
4514938471
Approval date
2014-05-04, 1393/02/14
Ethics committee reference number
zums.rec.1393.133
Health conditions studied
1
Description of health condition studied
Nonalcoholic steatohepatitis
ICD-10 code
K75.8
ICD-10 code description
Other specified inflammatory liver diseases, Nonalcoholic steatohepatitis [NASH]
Primary outcomes
1
Description
ALT
Timepoint
once at the begining and the second time after twelve weeks
Method of measurement
ELIZA
2
Description
FBS
Timepoint
once at the begining and the second time after twelve weeks
Method of measurement
ELIZA
3
Description
lipid profile
Timepoint
once at the begining and the second time after twelve weeks
Method of measurement
ELIZA
Secondary outcomes
1
Description
Improve fatty liver
Timepoint
once at the begining and the second time after twelve weeks
Method of measurement
Specific liver enzyme tests
Intervention groups
1
Description
Tab pioglitazone 30 mg once a day
Category
Treatment - Drugs
2
Description
Tab fenofibrat 200 mg once aday
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr.maryam jameshorani
Street address
Valiasr Hospital Valiasr sq Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Zanjan University Of Medical Sciences
Full name of responsible person
Dr. Maryam Jameshorani
Street address
Zanjan,Azadi Square, Zanjan University Of Medical Sciences.
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Zanjan University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan,University Of Medical Sciences
Full name of responsible person
Dr.Maryam Jameshorani
Position
Internist
Other areas of specialty/work
Street address
Zanjan,Vali Asr Square, Vali Asr Hospital
City
zanjan
Postal code
Phone
+98 24 3342 4766
Fax
Email
dr.shirinjameshorani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University Of Medical Siences
Full name of responsible person
Dr. maryam jame shorani
Position
Internist
Other areas of specialty/work
Street address
Zanjan,Vali Asr Square, Vali Asr Hospital
City
Zanjan
Postal code
Phone
+98 24 3342 4766
Fax
Email
dr.shirinjameshorani@zumz.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University Of Medical Sciences
Full name of responsible person
Dr.Maryam JameShorani
Position
Internist
Other areas of specialty/work
Street address
Zanjan,Vali Asr Square, Vali Asr Hospital
City
Zanjan
Postal code
Phone
+98 24 3342 4766
Fax
Email
dr.shirinjameshorani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)