Comparing the Empagliflozin with Pioglitazone effect on nonalcoholic fatty liver in diabetic type 2 patients treated with metformin
Design
An open-label, randomized clinical trial study with parallel groups and phases 3 on 60 patients. Randomization will be done with the block randomization method using Random allocation software.
Settings and conduct
This open-label, randomized clinical trial study will be conducted on 60 patients of type 2 diabetics and at least grade 2 of non-alcoholic fatty liver disease in Urmia Imam Khomeini Hospital.
Participants/Inclusion and exclusion criteria
In this study, 60 patients treated with metformin for at least three months with a minimum dose of 1500 mg daily and with at least grade 2 non-alcoholic fatty liver will be included. The main exclusion criteria included patients receiving drugs that stimulate insulin secretion, or insulin, type 1 diabetes, patients treated with diabetes drugs including sitagliptin and liraglutide, and other liver diseases including autoimmune hepatitis and viral hepatitis.
Intervention groups
In group one, patients will receive 30 mg pioglitazone daily, and in group two, 10 mg empagliflozin daily in addition to the standard treatment (metformin) for 6 months. If Hb A1c is not controlled after three months of intervention, the dose of metformin will be increased from 1500 to 2500 and the dose of empagliflozin will be increased from 10 to 25 mg. Patients who will not take at least 80% of the tablets during the study will be excluded.
Comparing the effect of Empagliflozin with Pioglitazone on nonalcoholic fatty liver in diabetic type 2 patients treated with metformin
Public title
Comparing the effect of Empagliflozin with Pioglitazone on nonalcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 to 75 years
Type 2 diabetes
A hemoglobin A1C (HbA1c) between 7 and 10
Body mass index (BMI) between 20 to 40 kg/m2
Treated with metformin for at least three months with a minimum dose of 1500 mg daily
َAt least grade 2 of non-alcoholic fatty liver disease (NAFLD)
Exclusion criteria:
Patients receiving drugs that stimulate insulin secretion, or insulin
Type 1 diabetes
Patients treated with diabetes drugs including sitagliptin and liraglutide
Glomerular Filtration Rate (GFR) less than 45
Uncontrolled or aggravated heart disease (class 3 and 4)
Liver diseases including autoimmune hepatitis and viral hepatitis
Alcohol consumption of more than 140 cc for women and 250 cc for men per week
Pregnancy
breastfeeding
History of urinary tract infection
Bladder Cancer
Age
From 20 years old to 75 years old
Gender
Both
Phase
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 two 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, and then in the block section, the Block randomization method will be implemented. According to the total sample size (60 patients), 15 blocks of 4 will be used. Patients will be allocated to intervention groups based on generated numbers.
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 Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat Ave, Jahad Blvd., Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2022-07-13, 1401/04/22
Ethics committee reference number
IR.UMSU.REC.1401.180
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Liver steatosis score
Timepoint
Before and 6 months after the intervention
Method of measurement
Fibroscan
2
Description
Alanine transaminase (ALT)
Timepoint
Before and 6 months after the intervention
Method of measurement
blood sample
3
Description
Aspartate transaminase (AST)
Timepoint
Before and 6 months after the intervention
Method of measurement
blood sample
4
Description
Alkaline phosphatase (ALKP)
Timepoint
Before and 6 months after the intervention
Method of measurement
blood sample
Secondary outcomes
1
Description
HbA۱c
Timepoint
Before and 6 months after the intervention
Method of measurement
Blood sample
2
Description
Cholesterol
Timepoint
Before and 6 months after the intervention
Method of measurement
Blood sample
3
Description
high-density lipoprotein (HDL)
Timepoint
Before and 6 months after the intervention
Method of measurement
Blood sample
4
Description
low-density lipoprotein (LDL)
Timepoint
Before and 6 months after the intervention
Method of measurement
Blood sample
5
Description
triglyceride
Timepoint
Before and 6 months after the intervention
Method of measurement
Blood sample
6
Description
Serum creatinine
Timepoint
Before and 6 months after the intervention
Method of measurement
Blood sample
7
Description
Glomerular filtration rate (GFR)
Timepoint
Before and 6 months after the intervention
Method of measurement
Based on the formula
8
Description
Serum insulin
Timepoint
Before and 6 months after the intervention
Method of measurement
Blood sample
Intervention groups
1
Description
Intervention group: In group one, patients will receive 30 mg pioglitazone daily in addition to the standard treatment (metformin) for 6 months.
Category
Treatment - Drugs
2
Description
Intervention group: in group two, patients will receive 10 mg empagliflozin daily in addition to the standard treatment (metformin) for 6 months.