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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190701044062N4

Enrollment

Registered

2021-01-19

Start date

2020-11-23

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

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

Interventions

Intervention 1: Intervention group: Patients will receive daily empagliflozin10 mg and metformin daily for 12 weeks. Intervention 2: Control group: Patients will receive daily pioglitazone 30 mg, vit

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.;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.;Liver enzymes levels before and after empagliflozin. Timepoint: At baseline and 3 months after the intervention. Method of measurement: Laboratory methods.;Ultrasound grade determination before and after empagliflozin administration. Timepoint: At baseline and 3 months after the intervention. Method of measurement: liver ultrasonography.	—

Measure

Time frame

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.;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.;Liver enzymes levels before and after empagliflozin. Timepoint: At baseline and 3 months after the intervention. Method of measurement: Laboratory methods.;Ultrasound grade determination before and after empagliflozin administration. Timepoint: At baseline and 3 months after the intervention. Method of measurement: liver ultrasonography.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactManouchehr Khoshbaten

Tabriz University of Medical Sciences

mkhoshbaten@yahoo.com+98 41 3337 2088

Outcome results

None listed

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