Evaluation of the effect of empagliflozin in combination with pioglitazone on fatty liver disease

Evaluation of the effect of empagliflozin in combination with pioglitazone on fatty liver disease in type 2 diabetic patients referred to Imam Reza hospital during December 2022 to December 2023.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240208060939N1

Enrollment

Registered

2024-03-03

Start date

2022-12-22

Completion date

Unknown

Last updated

2024-03-06

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

Conditions

Fatty liver. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group: This group will receive 15 to 30 mg of pioglitazone daily for 24 weeks. Intervention 2: Control group: This group will receive 15 to 30 mg of pioglitazone plus 10 m

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Having type 2 diabetes and fatty liver at the same time

Exclusion criteria

Exclusion criteria: Active or chronic hepatitis, cirrhosis and biliary disease Class III and IV heart failure Renal dysfunction GFR<45

Design outcomes

Primary

Measure	Time frame
AST,ALT. Timepoint: 0, 24 Week after. Method of measurement: Laboratory.;CAP score. Timepoint: 0, 24 Week after. Method of measurement: Sonography/Fibro Scan.;Nafld fibrosis score. Timepoint: 0, 24 Week after. Method of measurement: D fibrosis score = -1.675+0.037-age(years)+0.094-BMI(kg/m^2)+1.13× IFG/diabetes(yes=1,no=0)+0.99×AST/ALTratio-0.013×PLT- 0.66×albumin.;APRI ratio. Timepoint: 0, 24 Week after. Method of measurement: AST/PLT ratio.;FIB-4 index. Timepoint: 0, 24 Week after. Method of measurement: Age (years)×AST (U/L)/[PLT(109/L)×ALT1/2 (U/L)].	—

Measure

Time frame

AST,ALT. Timepoint: 0, 24 Week after. Method of measurement: Laboratory.;CAP score. Timepoint: 0, 24 Week after. Method of measurement: Sonography/Fibro Scan.;Nafld fibrosis score. Timepoint: 0, 24 Week after. Method of measurement: D fibrosis score = -1.675+0.037-age(years)+0.094-BMI(kg/m^2)+1.13× IFG/diabetes(yes=1,no=0)+0.99×AST/ALTratio-0.013×PLT- 0.66×albumin.;APRI ratio. Timepoint: 0, 24 Week after. Method of measurement: AST/PLT ratio.;FIB-4 index. Timepoint: 0, 24 Week after. Method of measurement: Age (years)×AST (U/L)/[PLT(109/L)×ALT1/2 (U/L)].

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfsaneh Vosoghi

Artesh University of Medical Sciences

afsaneh.vosoghi.1@gmail.com+98 21 8609 6350

Outcome results

None listed

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