Comparing the effect of Empagliflozin, Pioglitazone and their combination, on the course of non-alcoholic fatty liver disease in diabetic patients

Phase 2

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

• Registration Number: IRCT20230903059343N1
• Lead Sponsor: Arak University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

All patients with type 2 diabetes phenotype and fatty liver disease

Exclusion Criteria

History of alcohol ingestion
Cirrhosis
Heart failure, NYHA class III or IV
Chronic kidney disease with GFR<45 ml/min
Other chronic liver diseases including viral or autoimmune hepatitis
Current use of Empagliflozine or Pioglitazone
Use of known causative drugs for fatty liver including NSAIDs, Tamoxifen, Amiodarone and Valproate
Use of antioxidant agents during the past 3 months, including Vitamin C, Zinc or Selenium-containing supplements.
HbA1c less than 7 or more than 9 percent
Type 1 diabetes or diabetes due to a specific secondary cause
Pregnancy or Lactation
Active cancer during the last two years
Cardiovascular events during the last 3 months
History of hypothyroidism
Wilson's disease
BMI>40 kg/m2
History of biliary obstruction
Glucocorticoid use for 2 weeks during the last 2 months

Study & Design

• Study Type: interventional
• Study Design: Not specified