Efficacy of SGLT2 inhibitor for Non-Alcoholic Fatty Liver Disease

Phase 4

Recruiting

• Conditions: on Alcoholic Fatty Liver Disease; Type 2 Diabetes Mellitus; Obesity; C06.552.241.519; C18.452.394.750.149

• Registration Number: RBR-48rxwb
• Lead Sponsor: Centro Educacional Hyarte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients older than 20 years who present alterations in transaminases with cutoff above 35 U / l and hepatic fat content above 7.5% by MRI will be included.
Diabetic patients will include those with a disease duration of more than 6 months (under treatment) and less than 10 years; without the use of insulin therapy and using at maximum two oral antihyperglycaemic agents

Exclusion Criteria

The exclusion criteria will be: alcohol use more than 30 grams / day over 10 years for men and more than 20 grams / day for women; viral hepatitis B and C and HIV; drugs that impair beta oxidation (methotrexate, amiodarone, tetracycline, tamoxifen, chemotherapeutics); autoimmune hepatitis; biliary diseases; metabolic genetic disorders; ferritin above 1000 mg / dL; recurrent urinary tract infection; diabetics using GLP-1 analogs or in oral double therapy.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of hepatic fat content by MRI, at least 10% compared to first MRI before the treatment;Reduction of serum concentrations of transaminases, at least 10 u/l compared levels before the treatment

Secondary Outcome Measures

Name	Time	Method
Body weight reduction at least 5% compared to weight before treatment ;Increase of telomere length at least 5% compared before treatment ;Increased serum concentrations of IGF-1, at least 1 quartile compared before treatment