Comparing the effects of doses empagliflozin 10 mg and 25 mg on anthropometric index and liver enzymes in patients with non alcoholic fatty liver (NAFLD)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250314065071N1

Enrollment

116

Registered

2025-03-17

Start date

2025-04-21

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

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

Interventions

Intervention 1: Intervention groupA: Recipients will receive 10 mg of empagliflozin once daily for 3 months, and a weight-stabilizing diet that provides 26-27 kcal per kilogram of energy, with 50-55%

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: patients with non alcoholic fatty liver (NAFLD)referred to Gastroenterology and endocrine clinics of Zanjan city Patients with fasting blood sugar between 90 and 125 mg/dL Patients with HBA1C less than 6.5% ALT greater than 1.5 to 5 times normal Body mass index (BMI) =24

Exclusion criteria

Exclusion criteria: Patients with other secondary causes of fatty liver (viral and alcoholic osteohepatitis, Wilson's disease, hemochromatosis, metabolic liver disease) Patients taking any type of medication that affects the liver (phenytoin, amiodarone, tamoxifen, birth control pills, levothyroxine, estrogen, corticosteroids, etc.)

Design outcomes

Primary

Measure	Time frame
Aspart Aminotransferase (AST). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Aspart Aminotransferase specific laboratory kit.;Alanine Aminotransferase. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Alanine Aminotransferase specific laboratory kit.;Average changes in FIB-4 criteria. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Laboratory kit for Aspart Aminotransferase and Platelet, then using FIB-4 formula.;Anthropometric index includes weight, height, BMI, waist circumference, hip circumference, and waist-to-hip ratio. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: The method of measuring the weight variable of individuals will be measured with a seca scale with an accuracy of 0.1 kg, without shoes and with minimal clothing. The height, waist and hip circumference of individuals will also be measured using a non-elastic meter with an accuracy of 0.5 cm. The body mass index will also be calculated for each individual with the formula BMI = 2 (m) height / (Kg) weight. Also, the formula hip circumference / waist circumference = WHR will be used to calculate the waist-to-hip ratio.	—

Measure

Time frame

Aspart Aminotransferase (AST). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Aspart Aminotransferase specific laboratory kit.;Alanine Aminotransferase. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Alanine Aminotransferase specific laboratory kit.;Average changes in FIB-4 criteria. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Laboratory kit for Aspart Aminotransferase and Platelet, then using FIB-4 formula.;Anthropometric index includes weight, height, BMI, waist circumference, hip circumference, and waist-to-hip ratio. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: The method of measuring the weight variable of individuals will be measured with a seca scale with an accuracy of 0.1 kg, without shoes and with minimal clothing. The height, waist and hip circumference of individuals will also be measured using a non-elastic meter with an accuracy of 0.5 cm. The body mass index will also be calculated for each individual with the formula BMI = 2 (m) height / (Kg) weight. Also, the formula hip circumference / waist circumference = WHR will be used to calculate the waist-to-hip ratio.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Sahar Shafagh

Zanjan University of Medical Sciences

Saharshafagh323@gmail.com+98 24 3373 9028

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026