Evaluation of the effects of losartan on the improvment of liver function tests in Non Alcoholic Fatty Liver Disease(NAFLD)patients .
Design
Two arm parallel group, double blind ,randomised,controlled clinical trial design of 328 patients
Settings and conduct
patients who referred to Internal medicine Clinic of Imam Hossein Hospital of Tehran that diagnosed non alcoholic fatty liver disease(NFLD), with ultrasound and aspartate transaminase (AST) > 30 and alanine transaminase(ALT) > 40 and they have including criteria or dose not have excluding criteria enrolled.patients take drugs for 12 weeks. physition and who packaged drugs and patients are blind.drugs in both group have the same size and same shape and same package.
Participants/Inclusion and exclusion criteria
Inclution criterias; age of 20 to 80 years, pre hypertensive(i.e. systolic blood pressure (SBP): 120 to 139 mmHg, and diastolic blood pressure (DBP): 80 to 89 mmHg ,diagnosed with Non Alcoholic Fatty Liver Disease(NAFLD) based on ultrasound findings, liver enzymes as AST> 30 IUl and ALT> 40 IUl
Exclution criteria; positive viral hepatitis markers, positive Anti Mitocondrial Antibody(AMA) and Anti Nouclotide Antibody(ANA) , history of alcohol abuse, renal insufficiency, hypertention, pregnancy, cirrhosis, toxic hepetitis, treated with Angiotensin Converting Enzyme inhibitor(ACEi) or Angiotensin 2 Receptor Blockers or thiazolidinedione.
Intervention groups
Tablet Losartan 25 mg twice a day for intervention group
Plasebo for control group that as the same intervention group
: Investigation Effect of losartan on improving liver function testes in NAFLD patients ( Non Alcoholic Fatty Liver Disease)
Public title
Investigation Effect of losartan NAFLD patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with pre hypertension and fatty liver
Exclusion criteria:
history of other liver diseases except fatty liver
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
250
Actual sample size reached:
164
Randomization (investigator's opinion)
Randomized
Randomization description
We used block randomization method.each block size was 2 by 2, and in total 16 blocks were considered.the sequences for packages within each block were:AABB_BBAA_ABBA_BAAB_ABAB_BABA .then each were marked from 1 to 6 as above.After that the packages within blocks were sequentially numbered from 1 to 64.
Blinding (investigator's opinion)
Double blinded
Blinding description
The sample recipient and patient are not aware of the type of drug.the lab that received samples isn't aware of type of drug. losartan and placebo are same shape.and they pack same.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
koodakyari street.velenjak
City
Tehran
Province
Tehran
Postal code
1234569871
Approval date
2019-02-09, 1397/11/20
Ethics committee reference number
IR.sbmu.msp.REC.1397.325
Health conditions studied
1
Description of health condition studied
NAFLD
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
liver functions tests
Timepoint
liver function tests before losartan and 12 weeks after losartan
Method of measurement
laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: losartan 25 mg twice a day for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: placebo 25 mg twice aday for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein hospital
Full name of responsible person
Meghdad Sedaghat
Street address
Rasul_e Akram hospital, Mansuri Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 6435 1000
Email
sedaghat@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Ziai
Street address
koodakyari street .velenjak
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 6646 3443
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Meghdad Sedaghat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Rasul_e Akram hospital, Mansuri Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1324569871
Phone
+98 21 6435 1000
Email
sedaghat@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Meghdad Sedaghat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Rasul_ e Akram hospital, Mansuri Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1324569871
Phone
+98 21 6435 1000
Email
sedaghat@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Meghdad Sedaghat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Rasul_E Akram hospital, Mansuri Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1324569871
Phone
+98 21 6435 1000
Email
sedaghat@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is shared after unidentifiable people
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Use data to compare with other similar interventions
From where data/document is obtainable
Aylar fazlzadeh
dr.aylar.fazlzadeh@gmail.com
What processes are involved for a request to access data/document