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Effect of Empagliflozin in diabetic patients with non-alcoholic steatohepatitis

Phase 3
Recruiting
Conditions
non-alcoholic steatohepatitis.
Nonalcoholic steatohepatitis (NASH)
K75.81
Registration Number
IRCT20210609051526N2
Lead Sponsor
Babol University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
110
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

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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