Comparison of high-dose and low-dose empagliflozin on fatty liver-related indices in patients with type 2 diabetes.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250524065869N1

Enrollment

Registered

2025-06-09

Start date

2025-06-09

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Condition 1: Diabetes. Condition 2: Fatty Liver. Type 2 diabetes mellitus Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group: Patients with type 2 diabetes and NAFLD receiving empagliflozin 25 mg (high dose). This tablet is prescribed daily for 24 weeks. Intervention 2: Control group: Pati

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age above 18 and below 80. History of diabetes, defined as HbA1c > 6.4. Ultrasound indicating of fatty liver. Mental health and alertness, with informed consent. Glomerular filtration rate (GFR) above 60.

Exclusion criteria

Exclusion criteria: History of SGLT2 inhibitor use in the past 3 months. Contraindication to SGLT2 inhibitors, including recurrent urinary-genital infections and drug sensitivity. Secondary liver disease; including viral hepatitis, autoimmune hepatitis, and cholestasis. Cirrhosis or advanced liver disease. Use of corticosteroids, methotrexate, amiodarone, and other drugs that cause fatty liver. Alcohol addiction. Pregnant women. Failure to complete the follow-up period. Irregular use of empagliflozin.

Design outcomes

Primary

Measure	Time frame
Framingham Steatosis Index (FSI): If the calculated number is greater than zero, the likelihood of fatty liver increases; on the other hand, if the result is negative, it weighs against the presence of fatty liver. Timepoint: At the initial visit and after 24 weeks from the start of treatment. Method of measurement: History taking, Meter, Scale, Mercury blood pressure monitor and Standard laboratory.;FIB-4: Non-invasive index for liver fibrosis. Timepoint: At the initial visit and after 24 weeks from the start of treatment. Method of measurement: Standard laboratory.;Triglyceride-glucose (TyG) Index: Indicates insulin resistance, a marker for fatty liver. Timepoint: At the initial visit and after 24 weeks from the start of treatment. Method of measurement: Standard laboratory.	—

Measure

Time frame

Framingham Steatosis Index (FSI): If the calculated number is greater than zero, the likelihood of fatty liver increases; on the other hand, if the result is negative, it weighs against the presence of fatty liver. Timepoint: At the initial visit and after 24 weeks from the start of treatment. Method of measurement: History taking, Meter, Scale, Mercury blood pressure monitor and Standard laboratory.;FIB-4: Non-invasive index for liver fibrosis. Timepoint: At the initial visit and after 24 weeks from the start of treatment. Method of measurement: Standard laboratory.;Triglyceride-glucose (TyG) Index: Indicates insulin resistance, a marker for fatty liver. Timepoint: At the initial visit and after 24 weeks from the start of treatment. Method of measurement: Standard laboratory.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarshid Mollaghasem Shemirani

Artesh University of Medical Sciences

farshidshemirani@yahoo.com+98 21 27956

Outcome results

None listed

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