investigating the effect of empagliflozin on non-alcoholic fatty liver in type 2 diabetic patients referred to Loghman Hakim Hospital in 1400
Design
Sampling method:
The non-probability sampling method will be targeted. In this way, random method is not used in selecting patients in each group, but from the available patients, patients in each group will be selected based on the researcher's judgment up to the specified volume (70 people in each group) according to the purpose of the study.
Settings and conduct
The present study, after obtaining permission from the ethics committee of Shahid Beheshti University of Medical Sciences and the consent of the head of the internal department of Loghman Hakim Hospital, will be conducted as a clinical trial on 140 type 2 diabetic patients referred to the endocrine / diabetes / gastrointestinal clinic in 1400. Patients are equally divided into control and treatment groups. In the treatment group, in addition to the standard treatment, they will receive 10 mg of Empagliflozin daily for 6 months. In the control group, patients received only standard treatment and did not receive Empagliflozin.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes in the age group of 20 to 70 years who are candidates for treatment with Empagliflozin.
No history of Empagliflozin use
-GFR> 35ml / min / 1.73mn2
-HbA1c≤7.5%
Intervention groups
Patients with type 2 diabetes and fatty liver treated with empagliflozin and thiazolidinediones
Main outcome variables
Practical goals:
1.determining the level of insilin level,alt,ast,alkp,GGT,billi,FBS,HbA1c before and 3 and 6 months after the start of treatment
2.determining the degree of fatty liver by U.S and MRI before and 3 and 6 months after start if treatment
3.determining weigt and BMI before and 3 and 6 months after start of teratment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210811052150N1
Registration date:2023-01-28, 1401/11/08
Registration timing:retrospective
Last update:2023-01-28, 1401/11/08
Update count:1
Registration date
2023-01-28, 1401/11/08
Registrant information
Name
Fateme Shojaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4407 4360
Email address
fateme.shojai@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-11, 1400/05/20
Expected recruitment end date
2022-05-10, 1401/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Empagliflozine on the Non-Alcoholic Fatty Liver Disease in patients with type 2 diabetes mellitus
Public title
effect of Empagliflozine on the Non-Alchoholic Fatti Liver Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes in the age group of 20 to 70 years who are candidates for treatment with Empagliflozine
No history of using Empaglifozine
GFR>35ml/min/1.7m2
HbA1c≤7.5%
Satisfaction of patients or their legal guardians to attend the study and continue it
Exclusion criteria:
History of advanced liver and kidney disease
Cardiac surgery or angioplasty planned within the last 3 months
Bariatric surgery in last 2 years and other gastrointestinal surgeries that cause chronic malabsorotion
Bleeding or any disorder in causing hemolysis or unstable red blood cells(such as malaria)
Medical history of cancer(except basal cell cancer)or cancer treatment in the last 5 years
treatment with anti-obesity drugs in the 3 months prior ti informed consent or any other treatment at the time of screening(i.e. surgery;aggressive dieting;etc)that results in an unstable body weight
current treatment with systemic steroids or any uncontrolled endocrine disorder other than type 2 diabetes
cinsumtion of alcohol or drugs in the last 3 months
patients who during the treatment,another drug to control blood sugar was added to their teatment
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be simple and for each patient according to labeling initial amounts of the Pioglitazone (control group) and Empagliflozine(treatment group),using a randomizednumber chart.these same numbers will be written and sealed,and placed in a box for allocation concealment.The course of treatment for each patient will be selected by choosing the random numbers concealed in the box at the beginning of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study,blinding will e done for the patients as well aspart of the researchers who have the role of clinical caregivers and outcome assessors by coding packages containing empagliflozin and pioglitazone which are apparently the same.Then these codes will be the number of patients in one envelope,will be cast and chosen randomaly.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Makhsus avenu
City
Tehran
Province
Tehran
Postal code
1333625445
Approval date
2021-08-10, 1400/05/19
Ethics committee reference number
IR.SBMU.MSP.REC.1400.287
Health conditions studied
1
Description of health condition studied
Non-Alchoholic Fatty Liver Disease
ICD-10 code
K75.81
ICD-10 code description
Nonalcoholic steatohepatitis (NASH)
Primary outcomes
1
Description
Degree of fatty liver in MRI
Timepoint
Before treatment and six months after treatment
Method of measurement
MRI
2
Description
body mass index
Timepoint
before and three and six monthns after treatment
Method of measurement
Kg/m2
3
Description
fasting blood sugar
Timepoint
before and three and six months after treatmen
Method of measurement
blood sampling
4
Description
HbA1C
Timepoint
before and three and six months after teatment
Method of measurement
blood sampling
5
Description
the level of liver transaminases
Timepoint
before and three and six months after treatmenet
Method of measurement
blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with Non-Alcoliholic Fatty Liver disease and type 2 Diabetes are under intervention with Empagliflozine at a dose of 10 and 25 mg based on FBS and HbA1c for 6 months and after 3 and 6 months in terms of FBS,HbA1c,AST,ALT,ALKP and degree of fatty liver they are examined in MRI and ultrasound.
Category
Treatment - Drugs
2
Description
Control group: Patients with Non-Alcoliholic Fatty Liver disease and type 2 Diabetes treated with thiazolidinedione group drugs such aspioglitazone with a dose of15 and 30 mg based on FBS and HbA1c are monitored for 6 months in terms of FBS,HbA1c,AST,ALT,ALKP and liver grade fat is checked in MRI and ultrasound
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman hakim hospital
Full name of responsible person
Fateme Shojaee
Street address
Loghman Hakim Hospital,Makhsus Avenue
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 9005
Email
fateme.shojai@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Shojaee
Street address
Loghman Hakim Hospital,Makhsus Avenue
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 9005
Email
fateme.shojai@gmail.com
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
Fateme Shojaee
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Internal medicine resident
Street address
Loghman Hakim Hospital,Makhsus Avenue
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 9005
Email
fateme.shojai@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme shojaei
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal medicine resident
Street address
Loghman Hakim Hospital,Makhsus Avenue
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 9005
Email
Fateme.shojai@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Shojaee
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Internal medicine resident
Street address
Loghman Hakim Hospital,Makhsus Avenue
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 9005
Email
fateme.shojai@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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