Determination of the effect of N-acetylcysteine on serum levels of liver enzymes and metabolic profiles in patients with non-alcoholic fatty liver disease
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 74 patients
Settings and conduct
The study will be performed in the gastrointestinal clinic of Shahid Beheshti Hospital affiliated to Kashan University of Medical Sciences.Study participants were randomly assigned to receive N-acetylcysteine or placebo for 8 weeks. In addition, the tablets are provided to patients with separate codes 1 and 2 in order to blind the researchers and study participants by a trained expert.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Patients with non-alcoholic fatty liver disease based on diagnostic criteria.2. age 25 -75 years. 3. Non-smoking
Criteria for exclusion from the study: 1. Unwillingness to cooperate 2. Suffering from any acute and active infection. 3. Consumption of any type of supplement (vitamins, minerals, etc.) by the patient during the last 3 months. 4. Severe kidney failure (eGFR less than 30 ml / min) 5. Severe hepatic impairment 6. Diabetes mellitus 7. Hyperlipidemia requires drug treatment
Intervention groups
patients with non-alcoholic fatty liver disease are identified based on diagnostic criteria and then randomly divided to receive N-acetylcysteine or placebo for 8 weeks.
Main outcome variables
Insulin resistance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201220049772N1
Registration date:2021-02-20, 1399/12/02
Registration timing:registered_while_recruiting
Last update:2021-02-20, 1399/12/02
Update count:0
Registration date
2021-02-20, 1399/12/02
Registrant information
Name
Mehrdad Sinaeinejhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
mehrdad.sinaeinejhad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-06-15, 1400/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of N-acetylcysteine on serum liver enzymes and metabolic profiles in patients with non-alcoholic fatty liver disease
Public title
.Effect of N-acetylcysteeine on non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non-alcoholic fatty liver disease based on diagnostic criteria
Age 25 to 75 years
No smoking
Exclusion criteria:
Having any acute and active infection
Consumption of any kind of supplement (vitamins, minerals, etc.) by the patient during the last 3 months
Severe renal failure (eGFR less than 30 ml / min)
Severe liver failure
Diabet mellitus
Hyperlipidemia requires medical treatment
Age
From 25 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
The tablets are identified by a trained expert with separate codes 1 and 2 in order to blind the researchers and study participants. Patients are coded from 1 to 74 based on the time of referral to the gastroenterology clinic. 37 numbers are extracted by a table of random numbers and They form a group. The next 37 numbers extracted from the table of random numbers are placed in another group. In the end, each drug code is assigned to a group
Blinding (investigator's opinion)
Double blinded
Blinding description
The tablets are provided to patients with separate codes 1 and 2 in order to blind the researchers and study participants by a trained expert.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Shahid beheshti hospital., Ghotb ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
87159/81151
Approval date
2020-12-20, 1399/09/30
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.150
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver_N acetyle cysteine
ICD-10 code
ICD-10 code description
Non-alcoholic fatty liver
Primary outcomes
1
Description
Primary outcome variables in this study include insulin resistance
Timepoint
Calculation of insulin resistance at the beginning of the study and eight weeks after starting N acetylcysteine
Method of measurement
The Index-HOMA formula is used to calculate insulin resistance, which is the product of serum insulin (ml /µIU) multiplied by fasting plasma glucose (dL / mg) divided by 405.
Secondary outcomes
1
Description
Serum levels of liver enzymes
Timepoint
At the beginning of the study and eight weeks after starting to take N-acetylcysteine
At the beginning of the study and eight weeks after starting to take N-acetylcysteine
Method of measurement
Serum total cholesterol, C-LDL, C-HDL and triglyceride concentrations are measured enzymatically using an autoanalyzer. Determination of fasting blood sugar using glucose oxidase / peroxidase method Pars Azmoun Company, Tehran, Iran)
Intervention groups
1
Description
Intervention group: In this study, N-acetylcysteine tablets made by Osweh Company with a dose of 600 mg, 3 tablets for 8 weeks of intervention will be used.
Category
Treatment - Drugs
2
Description
Control group: In this study, placebo tablets, which are exactly the same shape and size as N-acetylcysteine tablets and made by Osweh company, will be used in the amount of three tablets daily for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Clinic of Shahid Beheshti Hospital, Kashan
Full name of responsible person
Mehrdad sinaeinejhad
Street address
Ghotb ravandi blvd, Shahid beheshti hospital
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
beheshtihospital@kaums.ac.ir
Web page address
http://beheshti.kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza banafshe
Street address
Vice Chancellor for Research and Technology of Kashan University of Medical Sciences,Ghotb ravandi blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0026
Email
beheshtihospital@kaums.ac.ir
Web page address
http://research.kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Sinaeinejhad mehrdad
Position
Medical resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ghotb ravandi blvd, Shahid beheshti hospital
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
00983155540026-9
Email
mehrdad.sinaeinejhad@gmail.com
Web page address
http://beheshti.kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehrdad Sinaeinejhad
Position
Internal medical resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ravand Street_shahid beheshti hospital
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Fax
Email
mehrdad.sinaeinejhad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehrdad Sinaeinejhad
Position
Internal medical resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ravand Street_shahid beheshti hospital
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Fax
Email
mehrdad.sinaeinejhad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome and secondary consequences can be shared
When the data will become available and for how long
Start the access period immediately after printing the results
To whom data/document is available
Physicians and researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any use of the documents must be with the permission of the researchers
From where data/document is obtainable
Dr. Abbas Arj; Address: Ghotb ravandi blvd, Shahid Beheshti Hospital, Postal Code: 87159/81151
Dr. Mohsen Razavizadeh; Address: Ghotb ravandi blvd, Shahid Beheshti Hospital, Postal Code: 87159/81151
What processes are involved for a request to access data/document
After receiving a written request from the applicant with the mentioned conditions, and his identity verification, the documents will reach him within a maximum of one month.