Comparing the effect of Empagliflozin with Pioglitazone on nonalcoholic fatty liver

Phase 3

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

• Registration Number: IRCT20220928056051N1
• Lead Sponsor: Oroumia University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age between 20 to 75 years
Type 2 diabetes
A hemoglobin A1C (HbA1c) between 7 and 10
Body mass index (BMI) between 20 to 40 kg/m2
Treated with metformin for at least three months with a minimum dose of 1500 mg daily
?At least grade 1 of non-alcoholic fatty liver disease (NAFLD)

Exclusion Criteria

Patients receiving drugs that stimulate insulin secretion, or insulin
Type 1 diabetes
Patients treated with diabetes drugs including sitagliptin and liraglutide
Glomerular Filtration Rate (GFR) less than 30
Uncontrolled or aggravated heart disease (class 3 and 4)
Liver diseases including autoimmune hepatitis and viral hepatitis
Alcohol consumption of more than 140 cc for women and 250 cc for men per week
Pregnancy
breastfeeding
History of recurrent urinary tract infection
Bladder Cancer

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
iver steatosis score. Timepoint: Before and 6 months after the intervention. Method of measurement: Fibroscan.;Alanine transaminase (ALT). Timepoint: Before and 6 months after the intervention. Method of measurement: blood sample.;Aspartate transaminase (AST). Timepoint: Before and 6 months after the intervention. Method of measurement: blood sample.;Alkaline phosphatase (ALKP). Timepoint: Before and 6 months after the intervention. Method of measurement: blood sample.

Secondary Outcome Measures

Name	Time	Method
HbA?c. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample.;Cholesterol. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample.;High-density lipoprotein (HDL). Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample.;Low-density lipoprotein (LDL). Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample.;Triglyceride. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample.;Serum creatinine. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample.;Glomerular filtration rate (GFR). Timepoint: Before and 6 months after the intervention. Method of measurement: Based on the formula.;Serum insulin. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample.