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

Phase 3

Recruiting

• Conditions: on.; Fatty (change of) liver, not elsewhere classified; K76.0

• Registration Number: IRCT20190701044062N4
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 66

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
iver 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.