Assessment of the empagliflozin effect on the non-alcoholic fatty liver of type 2 diabetic patients with metformin-containing regimens
Design
A clinical trial with the parallel control group, an open-label, randomized, phase3, on 60 patients, block randomization was used in SPSS for randomization
Settings and conduct
NAFLD can lead to cardiovascular disease, chronic kidney disease, and increased mortality. In this study, 60 patients in two groups, would be evaluated for the assessment of the empagliflozin effect on the treatment of non-alcoholic fatty liver.
Participants/Inclusion and exclusion criteria
Patients in the age range of 20-75 years with type 2 diabetes and with HbA1C= 6.5-10% and BMI >20 and weight change of less than 10% in the last three months are indicated for inclusion in this study if only they are treated with metformin 1500 mg daily for at least three months as monotherapy and have a definite diagnosis of NAFLD
Excluded patients: Type 1 diabetes, treated with other diabetes drugs except for metformin, Hx pancreatitis, or pancreatic-related diseases, ALT more than twice normal upper limits at baseline and eGFR below 60, decompensated heart failure (FC of 3 and 4), other liver diseases including autoimmune and viral hepatitis, alcohol consumption of more than 140 ccs for women and 250 ccs for men per week, pregnant woman or planning a pregnancy, and breastfeeding.
Intervention groups
Group one is metformin according to the instructions and in group two, 25 mg of empagliflozin once daily will be added to the standard treatment and will be re-evaluated within 6 months. Finally, at the end of the study, they undergo an ultrasound and fiber scan to redefine the liver stage.
Main outcome variables
FBS
LDL
HDL
Cholesterol
Triglyceride
AST
ALT
ALKP
HbA1C
CAP score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220115053717N1
Registration date:2022-06-17, 1401/03/27
Registration timing:prospective
Last update:2022-06-17, 1401/03/27
Update count:1
Registration date
2022-06-17, 1401/03/27
Registrant information
Name
Reza Pourahmadazar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3344 1499
Email address
r.poorahmadazar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-19, 1401/03/29
Expected recruitment end date
2022-12-19, 1401/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the Empagliflozin effect on nonalcoholic fatty liver in patients with diabetic type 2 with metformin-containing regimens
Public title
Investigating the Empagliflozin effect on nonalcoholic fatty liver in patients with diabetic type 2 with metformin-containing regimens
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Controlled type 2 Diabetes Mellitus (T2DM) with HbA1C=6.5-10
BMI greater than 20, with the last 3 months loss of weight below 10%
treatment with Metformin, 1500mg daily, at least 3 months as monotherapy
Statin consumption
Definitive diagnosis of NAFLD under the supervision of a Gastroenterology subspecialty
Exclusion criteria:
Type 1 Diabetes Mellitus (T1DM)
Treated with other diabetes medications except for metformin at baseline
History of pancreatitis or pancreas related diseases
At the beginning of the study ALT more than twice normal upper limits
eGFR lower than 60 ml/min
Decompensated or untreated Heart Failure (functional class 3 or 4)
Other liver diseases include autoimmune hepatitis and viral hepatitis
Alcohol consumption more than 140 cc for women and 250 cc for men per week
A pregnant woman or someone who is planning a pregnancy
breastfeeding
Age
From 20 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention or control groups using the block randomization method based on generated numbers by Random allocation software. Thus, in this software, first, the number of groups and the total determined sample size will be entered (60 patients), and then in the block section, the Block randomization method will be implemented. Patients will be allocated to groups based on generated numbers.
Random Allocation Software version 1.0.0 has been developed by Mr. Saghaei, MD. department of
anesthesia, Isfahan University of Medical Sciences, Isfahan, Iran.
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
Ethics Committees of Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Approval date
2022-01-02, 1400/10/12
Ethics committee reference number
IR.UMSU.HIMAM.REC.1400.010
Health conditions studied
1
Description of health condition studied
Type 2 diabetic patients with nonalcoholic fatty liver disease
ICD-10 code
5A11, DB92
ICD-10 code description
type 2 diabetes mellitus, nonalcoholic fatty liver disease
Primary outcomes
1
Description
CAP score or STAGE determination index of steatohepatitis that is measured and evaluated by Fibroscan
Timepoint
at the beginning and the end of study of(after 6 months of treatment)
Method of measurement
Fibroscan device and its analysis by an experienced unit
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Treatment with metformin according to standard instructions and methods
Category
Treatment - Drugs
2
Description
Intervention group: Treatment with Empagliflozin 25 mg once in the morning added to the standard treatment (Metformin)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini University Hospital
Full name of responsible person
Laya Hooshmand Qarehbagh
Street address
Imam Khomeini University Hospital, Ershad St.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Email
laya.hooshmand58@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Laya Hooshmand Qarehbagh
Street address
Imam Khomeini University Hospital, Ershad St.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Email
laya.hooshmand58@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Laya Hooshmand Qarehbagh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini University Hospital, Ershad St.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Email
laya.hooshmand58@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Laya Hooshmand Qarehbagh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini University Hospital, Ershad St.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Email
laya.hooshmand58@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Laya Hooshmand Qarehbagh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini University Hospital, Ershad St.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Email
laya.hooshmand58@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data that support the findings of this study are available from the corresponding author, L. H., upon reasonable request.
When the data will become available and for how long
The data that support the findings of this study are available from the corresponding author, L. H., upon reasonable request.
To whom data/document is available
The data that support the findings of this study are available from the corresponding author, L. H., upon reasonable request.
Under which criteria data/document could be used
The data that support the findings of this study are available from the corresponding author, L. H., upon reasonable request.
From where data/document is obtainable
The data that support the findings of this study are available from the corresponding author, L. H., upon reasonable request.
What processes are involved for a request to access data/document
The data that support the findings of this study are available from the corresponding author, L. H., upon reasonable request.