effect of Empagliflozine on the Non-Alchoholic Fatti Liver Disease

Phase 2

• Conditions: on-Alchoholic Fatty Liver Disease.; Nonalcoholic steatohepatitis (NASH); K75.81

• Registration Number: IRCT20210811052150N1
• Lead Sponsor: Shahid Beheshti 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: 140

Inclusion Criteria

Patients with type 2 diabetes in the age group of 20 to 70 years who are candidates for treatment with Empagliflozine
No history of using Empaglifozine
GFR>35ml/min/1.7m2
HbA1c=7.5%
Satisfaction of patients or their legal guardians to attend the study and continue it

Exclusion Criteria

History of advanced liver and kidney disease
Cardiac surgery or angioplasty planned within the last 3 months
Bariatric surgery in last 2 years and other gastrointestinal surgeries that cause chronic malabsorotion
Bleeding or any disorder in causing hemolysis or unstable red blood cells(such as malaria)
Medical history of cancer(except basal cell cancer)or cancer treatment in the last 5 years
treatment with anti-obesity drugs in the 3 months prior ti informed consent or any other treatment at the time of screening(i.e. surgery;aggressive dieting;etc)that results in an unstable body weight
current treatment with systemic steroids or any uncontrolled endocrine disorder other than type 2 diabetes
cinsumtion of alcohol or drugs in the last 3 months
patients who during the treatment,another drug to control blood sugar was added to their teatment

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of fatty liver in MRI. Timepoint: Before treatment and six months after treatment. Method of measurement: MRI.;Body mass index. Timepoint: before and three and six monthns after treatment. Method of measurement: Kg/m2.;Fasting blood sugar. Timepoint: before and three and six months after treatmen. Method of measurement: blood sampling.;HbA1C. Timepoint: before and three and six months after teatment. Method of measurement: blood sampling.;The level of liver transaminases. Timepoint: before and three and six months after treatmenet. Method of measurement: blood sampling.