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Comparison of the therapeutic effect of empagliflozin with pioglitazone and vitamin E on non-alcoholic fatty liver in patients with type 2 diabetes

Protocol summary

Study aim
Comparison of the effect of empagliflozin with pioglitazone and vitamin E on liver enzymes and grades of fatty liver in type 2 diabetic patients with nonalcoholic fatty liver
Design
This is a randomized study with parallel groups on 66 patients to control diabetic patients with fatty liver with ampagliflozin or pioglitazone and vitamin E. The subjects are randomly assigned to 1: 1 ratios in the intervention or control groups.
Settings and conduct
This study performed in patients with non-alcoholic fatty liver and diabetic who were assigned to the intervention and control groups. Patients who have evidence of fatty liver on ultrasound will be included or excluded to the study through inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Patients with non-alcoholic fatty liver disease (NAFLD) are referred to the Valiasr Hospitals in Tabriz. Inclusion criteria included: patients 18 - 75 years, BMI <45 kg / m2, a known case of type 2 diabetes used by metformin, a known case of fatty liver, HbA1c are between 6-8%.Exclusion criteria also included History of hypoglycemia liver disease Other than non-alcoholic fatty liver Previous use of thiazolidinedione treatment،, immunomodulatory, antiobesity, anti-NASH glucagon-like peptide 1 agonists, sodium–glucose cotransporter 2 inhibitors, or vitamin E, amiodarone, tamoxifen, methotrexate In the last six months,severe heart, lung and kidney disease,Contraindications to the use of empagliflozin ,Uncontrolled type 2 diabetes,Changes in diet and activity during the study.
Intervention groups
Intervention group will receive daily empagliflozin 10mg and metformin for 12 weeks, and the other group will receive daily pioglitazone 30 mg and vitamin E and metformin daily for 12 weeks.
Main outcome variables
Levels of AST, ALT and grades of fatty liver

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190701044062N4
Registration date: 2021-01-19, 1399/10/30
Registration timing: registered_while_recruiting

Last update: 2021-01-19, 1399/10/30
Update count: 0
Registration date
2021-01-19, 1399/10/30
Registrant information
Name
manouchehr khoshbaten
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 3010
Email address
mkhoshbaten@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-23, 1399/09/03
Expected recruitment end date
2022-03-19, 1400/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of empagliflozin with pioglitazone and vitamin E on non-alcoholic fatty liver in patients with type 2 diabetes
Public title
Comparison of the therapeutic effect of empagliflozin with pioglitazone and vitamin E on non-alcoholic fatty liver in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 75 years old BMI <45 kg/m2 A known case of type 2 diabetes used by metformin A known case of non-alcoholic fatty liver HbA1c 6–8%
Exclusion criteria:
History of hypoglycemia liver disease Other than non-alcoholic fatty liver Previous use of thiazolidinedione treatment،, immunomodulatory, antiobesity, anti-NASH glucagon-like peptide 1 agonists, sodium–glucose cotransporter 2 inhibitors, or vitamin E, amiodarone, tamoxifen, methotrexate In the last six months severe heart, lung and kidney disease Contraindications to the use of empagliflozin (drug allergy, recurrence of genital urinary tract infection, history of recent or previous gangrene) Uncontrolled type 2 diabetes Changes in diet and activity during the study
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into control and intervention groups (1: 1). Patients will be assigned to two groups using the randomized block method. Patients will be divided into two equal groups using a random number table. STATA software will be used to generate a random sequence.
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 committee of Tabriz University of Medical Sciences
Street address
Central Office of Tabriz University of Medical Sciences Tabriz, Golghast Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165663755
Approval date
2020-11-22, 1399/09/02
Ethics committee reference number
IR.TBZMED.REC.1399.796

Health conditions studied

1

Description of health condition studied
Non
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Liver enzymes levels before and after vitamin E and pioglitazone administration
Timepoint
At baseline and 3 months after the intervention
Method of measurement
Laboratory methods

2

Description
Ultrasound grade determination before and after vitamin E and pioglitazone administration
Timepoint
At baseline and 3 months after the intervention
Method of measurement
liver ultrasonography

3

Description
Liver enzymes levels before and after empagliflozin
Timepoint
At baseline and 3 months after the intervention
Method of measurement
Laboratory methods

4

Description
Ultrasound grade determination before and after empagliflozin administration
Timepoint
At baseline and 3 months after the intervention
Method of measurement
liver ultrasonography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients will receive daily empagliflozin10 mg and metformin daily for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: Patients will receive daily pioglitazone 30 mg, vit E and metformin for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Manouchehr Khoshbaten
Street address
Aflaknoma Squ, Niayesh Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166618564
Phone
+98 41 3327 3000
Email
tvaliasrhospital@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmodpour
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2084
Email
a.mahmoodpour@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2088
Email
mkhoshbaten@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 1334 3010
Email
mkhoshbaten@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 1334 3010
Email
mkhoshbaten@yahoo.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
No - There is not 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
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