Clinical evaluation of empagliflozin with diabetic patient by non alcoholic fatty liver and investigating of sonography
Design
Clinical trial with control group , community_based and pragmatic , with parallel group , randomized, design of 30patient
Settings and conduct
Non random sampling : 30 diabetic patient with non alcoholic fatty liver in one groups of 30 people, is done in Farhikhtegan hospitals , investigating of sonography during the start of the test and then after 3 month treatment with empagliflozin investigating of sonography and comparison of them .
Participants/Inclusion and exclusion criteria
Inclusion criteria : Physician's diagnosis of diabetic patient with non alcoholic fatty liver , consent and cooperation of the patient to use the made capsule. Exclusion criteria: change in regimen during the study , Male gender any history of gastric or dermatic hypersensitivity to products , use drugs for treatment non alcoholic fatty liver
Intervention groups
The case group of 30 diabetic patient with non alcoholic fatty liver are treatment with empagliflozin , and then investigating of the sonography after 3 month
Main outcome variables
Fatty liver
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150706023084N18
Registration date:2023-09-02, 1402/06/11
Registration timing:retrospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
MARYAM SHIEHMORTEZA
Name of organization / entity
AZAD UNIVERSITY PHARMACEUTICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 212640056
Email address
shiehmorteza@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-11, 1402/05/20
Expected recruitment end date
2023-09-02, 1402/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of empagliflozin on patients with non alcoholic fatty liver diseases
Public title
Empagliflozin in non alcoholic fatty liver
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patient
Fatty liver
Empagliflozin
Exclusion criteria:
Drug use for fatty liver
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Investigating the effect of empagliflozin on diabetic patient with non alcoholic fatty liver
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University
Street address
No.99, Yakhckal street, DR Shariati Avenue
City
TEHRAN
Province
Tehran
Postal code
193956466
Approval date
2023-04-18, 1402/01/29
Ethics committee reference number
IR.IAU.PS.REC.1402.041
Health conditions studied
1
Description of health condition studied
Diabetic patient with non alcoholic fatty liver
ICD-10 code
K75.8
ICD-10 code description
Other specified inflammatory liver diseases
Primary outcomes
1
Description
Different grades of fatty liver
Timepoint
Before the intervention and 30 days after it, the question paper and sonography and fibroscan analysis data will be evaluated.
Method of measurement
Investigating of sonography(fibroscan)
Secondary outcomes
1
Description
Investigating sonography related to the course of recovery during treatment
Timepoint
From the beginning of treatment for 3 month
Method of measurement
Examining the sonography of the patients
Intervention groups
1
Description
Intervention group : The case group are 30 patient with diabetic and non alcoholic fatty liver with treatment by empagliflozin in 3 month and then investigating of the result of empagliflozin by fatty liver by resulting of the sonography of patient
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farhikhtegan Hospital
Full name of responsible person
Maryam Shiehmorteza
Street address
Islamic Azad Univesity Square, North Sattari, Tehran
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 3334 8035
Email
Farhikhteganhospital@gmail.com
Web page address
https://tms.iau.ir/farhikhtegan/fa/page/1272/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Shiehmorteza
Street address
No 99,Yasman Alley,Yakhchal street,Gholhak, Dr. Shariati street
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0599
Email
shiehmorteza@iaups.ac.ir
Web page address
https://tms.iau.ir/farhikhtegan/fa/page/1272/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
Mobina shieh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No 99 , Yasman Alley , Yakhchal street , Gholhak , Dr . Shariati street
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 6659 6099
Email
mobinashieh123@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mobina shieh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No.99, Yakhckal street, DR Shariati Avenue
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 6659 6099
Email
mobinashieh123@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Shiehmorteza
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No.99, Yakhckal street, DR Shariati Avenue
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 6659 6099
Email
mobinashieh123@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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The age, gender and demographic information of the patients as well as the results of the sonography and the questionnaire containing the symptoms of the patients at the beginning, during and at the end of the treatment period by removing the individual characteristics of the patients can be shared.
When the data will become available and for how long
The release time of the documents and files is after the completion of the project and in the winter of 1402.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
By observing the ethical principles of concealment of information, documents and all the checks carried out on the information can be published.
From where data/document is obtainable
mobinashieh123@gmail.com
What processes are involved for a request to access data/document