Evaluation of the effectiveness of Empagliflozin on metabolic factors and liver function tests in type 2 diabetic patients with non-alcoholic fatty liver, a clinical trial study
Determining the effectiveness of empagliflozin on metabolic factors and liver enzymes in type 2 diabetic patients with non-alcoholic fatty liver disease.
Design
It is a single-group trial-clinical research that is conducted on 30 type 2 diabetic patients with non-alcoholic fatty liver disease. These patients were treated with metformin and empagliflozin and at the end the results were compared before and after the intervention.
Settings and conduct
This study is conducted as a single arm in Tehran and with the presence of only one group of patients and the results are compared before and after. Blood samples will be taken from all patients at the beginning and end of the study. The treatment is under the supervision of a doctor and will continue for 8 weeks.
Participants/Inclusion and exclusion criteria
All type 2 diabetic patients with non-alcoholic fatty liver disease
Consent to participate in the study
Age between 20 and 65 years
Healthy physical condition
No history of taking SGLT2 inhibitor drugs
Not pregnant for women
Not having a history of malignancy and diseases such as AIDS and hepatitis
Intervention groups
Type 2 diabetic patients treated with empagliflozin
Main outcome variables
Blood Glucose, triglyceride, SGOT, SGPT, ALK,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191209045671N3
Registration date:2024-04-29, 1403/02/10
Registration timing:prospective
Last update:2024-04-29, 1403/02/10
Update count:0
Registration date
2024-04-29, 1403/02/10
Registrant information
Name
Habib Yaribeygi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4170
Email address
habib.yari@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-09, 1403/02/20
Expected recruitment end date
2024-09-10, 1403/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Empagliflozin on metabolic factors and liver function tests in type 2 diabetic patients with non-alcoholic fatty liver, a clinical trial study
Public title
Evaluation of the effectiveness of Empagliflozin on metabolic factors and liver function tests
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All type 2 diabetic patients with non-alcoholic fatty liver
Having the consent to participate in the study
Age between 20 to 65 years
Healthy physical status
Exclusion criteria:
history of taking SGLT2 inhibitors
being pregnant for women
history of malignancy and diseases such as AIDS and hepatitis
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
5 km of Damghan road
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2023-09-02, 1402/06/11
Ethics committee reference number
IR.SEMUMS.REC.1402.110
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Serum SGPT level
Timepoint
Before and after the study
Method of measurement
Biochemical-laboratory methods
2
Description
Serum SGOT level
Timepoint
Before and after the intervention
Method of measurement
Biochemical-laboratory methods
3
Description
blood glucose level
Timepoint
Before and after the intervention
Method of measurement
Biochemical-laboratory methods
4
Description
Serum ALK level
Timepoint
Before and after the intervention
Method of measurement
Biochemical-laboratory methods
Secondary outcomes
empty
Intervention groups
1
Description
Type 2 diabetic patients with non-alcoholic fatty liver disease will be treated with metformin (1000 mg orally daily) and empagliflozin (10 mg orally daily) for 8 weeks.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Habib Yaribeygi
Position
Academic member
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
basij
City
semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3365 4170
Email
habib.yari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Habib Yaribeygi
Position
Academic member
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
basij
City
semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3365 4170
Email
habib.yari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Position
Academic member
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
basij
City
semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Email
majidmirmohammadkhani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
it has no ethical approve.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the data will be published in the form of a project report and article.
When the data will become available and for how long
Raw data will not be published. But the final results will be published in the form of reports and articles about 6 months after the end of the project.
To whom data/document is available
Everyone can read the final report and the resulting article.
Under which criteria data/document could be used
just for writing the final report and article
From where data/document is obtainable
Physiology Research Center of Semnan University of Medical Sciences
What processes are involved for a request to access data/document
Raw data will not be published (due to ethical issues)