Effect of Empagliflozin in diabetic patients with non-alcoholic steatohepatitis

Effect of Empagliflozin on Liver Enzymes level in type two Diabetic Patients with Non-Alcoholic Steatohepatitis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210609051526N2

Enrollment

110

Registered

2021-09-15

Start date

2021-09-23

Completion date

Unknown

Last updated

2021-11-01

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

Conditions

non-alcoholic steatohepatitis. Nonalcoholic steatohepatitis (NASH)

Interventions

Intervention 1: Intervention group: Standard treatment for type 2 diabetes with one 10 mg Empagliflozin tablet daily. Intervention 2: Control group: Standard treatment for type 2 diabetes with one pla

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Body mass index less than 35 Kg/mm No history of chronic alcohol usage No history of viral hepatities No history of autoimmune hepatitis No history of drug-induced hepatitis No history of chronic usage of hepatic-steatosis-induced drugs(e.g.: Amiodarone, Valproate, Tamoxifen, Methotrexate, Glucocorticoids) No history of chronic usage of Thiazolidines and GLP-1 agonists Absence of evidence suggestive for cirrhosis based on physical examination, laboratory evaluation, and imaging studies Absence of evidence suggestive for Hepatocellular carcinoma based on physical examination, laboratory evaluation, and imaging studies Non pregnant women No previous history of HELLP syndrome in women No history of chronic kidney disease No history of chronic usage of Omega-3 containing supplements No contraindication for Empagliflozin usage (e.g.: history of recurrent genitourinary tract infection, gangrene, history of allergic reaction to the drug, serum Trigliceride level more than 500 mg/dl)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Alanine transaminase. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Serum level measurement.;Alkaline phosphatase. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Serum level measurement.;Body weight. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Using scales and in kilograms.;Weight cirmucfrences. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Using meters and in centimeters.;Aspartate transaminase. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Serum level measurement.	—

Measure

Time frame

Alanine transaminase. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Serum level measurement.;Alkaline phosphatase. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Serum level measurement.;Body weight. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Using scales and in kilograms.;Weight cirmucfrences. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Using meters and in centimeters.;Aspartate transaminase. Timepoint: Before the start of the study, 12 and 24 weeks after the start of treatment. Method of measurement: Serum level measurement.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Meftah

Babol University of Medical Sciences

n.meftah@mubabol.ac.ir+98 11 3233 8301

Outcome results

None listed

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