Investigating the Empagliflozin effect on nonalcoholic fatty liver in patients with diabetic type 2 with metformin-containing regimens

Phase 2

Conditions: Type 2 diabetic patients with nonalcoholic fatty liver disease.
type 2 diabetes mellitus, nonalcoholic fatty liver disease
5A11, DB92

Registration Number: IRCT20220115053717N1

Lead Sponsor: Oroumia University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 60

Inclusion Criteria

Controlled type 2 Diabetes Mellitus (T2DM) with HbA1C=6.5-10
BMI greater than 20, with the last 3 months loss of weight below 10%
treatment with Metformin, 1500mg daily, at least 3 months as monotherapy
Statin consumption
Definitive diagnosis of NAFLD under the supervision of a Gastroenterology subspecialty
at least grade 1 of non-alcoholic fatty liver disease (NAFLD) based on ultrasonography

Exclusion Criteria

Type 1 Diabetes Mellitus (T1DM)
Treated with other diabetes medications except for metformin at baseline
History of pancreatitis or pancreas related diseases
At the beginning of the study ALT more than twice normal upper limits
eGFR lower than 45 ml/min
Decompensated or untreated Heart Failure (functional class 3 or 4)
Other liver diseases include autoimmune hepatitis and viral hepatitis
Alcohol consumption more than 140 cc for women and 250 cc for men per week
A pregnant woman or someone who is planning a pregnancy
breastfeeding

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CAP score or STAGE determination index of steatohepatitis that is measured and evaluated by Fibroscan. Timepoint: at the beginning and the end of study of(after 6 months of treatment). Method of measurement: Fibroscan device and its analysis by an experienced unit.

Secondary Outcome Measures