Comparing the effect of Empagliflozin, Pioglitazone and their combination, on the course of non-alcoholic fatty liver disease in diabetic patients

Comparing the effect of Empagliflozin, Pioglitazone and their combination, on sonographic and biochemical features of non-alcoholic fatty liver disease in diabetic patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230903059343N1

Enrollment

120

Registered

2023-10-04

Start date

2023-10-16

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group: Recipients of Empagliflozin 10mg daily for 6 months. Intervention 2: Intervention group: Recipients of Pioglitazone 15 mg daily for 6 months. Intervention 3: Interv

Eligibility

Sex/Gender

All

Age

20 Years to 65 Years

Inclusion criteria

Inclusion criteria: All patients with type 2 diabetes phenotype and fatty liver disease

Exclusion criteria

Exclusion criteria: History of alcohol ingestion Cirrhosis Heart failure, NYHA class III or IV Chronic kidney disease with GFR40 kg/m2 History of biliary obstruction Glucocorticoid use for 2 weeks during the last 2 months

Design outcomes

Primary

Measure	Time frame
The proportion of patients in Empagliflozin treatment group who achieve meaningful (at least one grade) decrease in sonographic grade of their fatty liver disease. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment.;The proportion of patients in Pioglitazone treatment group who achieve meaningful (at least one grade) decrease in sonographic grade of their fatty liver disease. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment.;The proportion of patients in Empagliflozin plus Pioglitazone treatment group who achieve meaningful (at least one grade) decrease in sonographic grade of their fatty liver disease. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment.;The mean change in sonographic grade in Empagliflozin group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment.;The mean change in sonographic grade in Pioglitazone group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment.;The mean change in sonographic grade in ?Empagliflozin plus Pioglitazone group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment.;The mean change of APRI (AST to Platelet Ratio Index) score in Empagliflozin group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Specific laboratory kit for Aspartate aminotransferase and Platelets, then using APRI formula.;The mean change of APRI (AST to Platelet Ratio Index) score in Pioglitazone group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Specific laboratory kit for Aspartate aminotransferase and Platelets, then using APRI formula.;The mean change of APRI (AST to Platelet Ratio Index) score in Empagliflozin plus Pioglitazone group. Timepoint: At the start of the study, then	—

Measure

Time frame

The proportion of patients in Empagliflozin treatment group who achieve meaningful (at least one grade) decrease in sonographic grade of their fatty liver disease. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment.;The proportion of patients in Pioglitazone treatment group who achieve meaningful (at least one grade) decrease in sonographic grade of their fatty liver disease. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment.;The proportion of patients in Empagliflozin plus Pioglitazone treatment group who achieve meaningful (at least one grade) decrease in sonographic grade of their fatty liver disease. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment.;The mean change in sonographic grade in Empagliflozin group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment.;The mean change in sonographic grade in Pioglitazone group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment.;The mean change in sonographic grade in ?Empagliflozin plus Pioglitazone group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Sonography equipment.;The mean change of APRI (AST to Platelet Ratio Index) score in Empagliflozin group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Specific laboratory kit for Aspartate aminotransferase and Platelets, then using APRI formula.;The mean change of APRI (AST to Platelet Ratio Index) score in Pioglitazone group. Timepoint: At the start of the study, then 6 months later. Method of measurement: Specific laboratory kit for Aspartate aminotransferase and Platelets, then using APRI formula.;The mean change of APRI (AST to Platelet Ratio Index) score in Empagliflozin plus Pioglitazone group. Timepoint: At the start of the study, then

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Erfan Rezaeisafa

Arak University of Medical Sciences

Sorbsorbian@gmail.com+98 86 3417 3639

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026