Efficacy of SGLT2 inhibitor for Non-Alcoholic Fatty Liver Disease

Evaluation of the efficacy of SGLT2 inhibitor for Non-alcoholic Fatty Liver Disease in diabetics and non-diabetics: clinical trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-48rxwb

Enrollment

Unknown

Registered

2020-01-02

Start date

2019-11-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Alcoholic Fatty Liver Disease

Interventions

Experimental group: 80 patients will receive ISGLT2 (dapagliflozin 10 mg - 1 cp daily) Control group: 80 patients will receive placebo for 12 months (tablet without active substance made of starch).

Drug

C06.552.241.519

E02.319

Eligibility

Age

20 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Brazil

Contacts

Public ContactDebora da Silva

Centro Educacional Hyarte

endocrinodebora@gmail.com+55-38-999218763

Outcome results

None listed

Source: REBEC (via WHO ICTRP)