Therapeutic Response of Sodium-glucose Co-transporter Type-2 Inhibitor in Non-diabetic MAFLD Patients: a Pilot Study

Metabolic Associated Fatty Liver Disease Clinical Trial

Official title:

Therapeutic Response of Sodium-glucose Co-transporter Type-2 Inhibitor in Non-diabetic MAFLD Patients: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05782972
• Other study ID #: TCRD-TPE-112-11
• Status: Recruiting
• Phase: Phase 4
• Start date: March 11, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: August 2023
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: Chia-Chi Wang, Professor
• Phone: +886970333687
• Email: uld888[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this single arm, prospective study is to test the therapeutic response of oral dapagliflozin (Forxiga) 10 mg/day for 24 weeks in non-diabetic MAFLD patients. The primary outcomes are the improvement of liver inflammation or fibrosis parameters after 24 weeks treatment. The adverse events were also recorded.

Description:

This is single-arm, prospective study and 50 non-diabetic MAFLD patients are enrolled consecutively at Taipei Tzu Chi Hospital. The non-diabetic definition is no previous history of diabetes mellitus and HbA1C < 6.5%. Fatty liver was diagnosed by imaging such as liver ultrasound or histologic examination. Metabolic dysfunction was defined as overweight/obese, or more than 2 metabolic abnormalities in lean/normal weight subjects. Inclusion criteria were ALT elevation (>35 U/L in male and >25 U/L in female) or FIB-4 >=1.45. Those with cancer history, systolic blood pressure < 100 mmHg, or eGFR < 30 ml/min/1.73m2, or history of urinary tract infection/genital yeast infection were excluded. They received oral dapagliflozin (Forxiga) 10 mg/day for 24 weeks. The primary outcomes are the change of liver inflammation marker (serum ALT level)or fibrosis parameters after 24 weeks treatment. The adverse events were also recorded. The severity of liver fibrosis was determined using NAFLD-fibrosis score and ultrasound-based elastography method (ARFI). Total 6 visits Visit 1 (screening): US, ARFI, body composition measurement, BP, BMI, Waist circumference, body fat (%), AST/ALT, albumin, GGT, Cr, TG, CHO, HDL/LDL, glucose ac, HbA1C, Platelet, insulin, CRP Visit 2 (2 weeks): BP, AST/ALT, Cr Visit 3 (4 weeks): BP, BMI, Waist circumference, body fat (%), AST/ALT, albumin, GGT, Cr, TG, glucose ac, HbA1C, platelet Visit 4 (3 months):BP, BMI, Waist circumference, body fat (%), AST/ALT, albumin, GGT, Cr, TG, glucose ac, HbA1C, platelet Visit 5 (6 months): US, ARFI, body composition measurement, BP, BMI, Waist circumference, body fat (%), AST/ALT, albumin, GGT, Cr, TG, CHO, HDL/LDL, glucose ac, HbA1C, Platelet, insulin, CRP Visit 6 (Month 3 off-therapy): BP, BMI, Waist circumference, body fat (%), AST/ALT, albumin, GGT, Cr, TG, CHO, HDL/LDL, glucose ac, HbA1C, Platelet Record adverse events and number of pills left in each visits

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• MAFLD patients (hepatic steatosis plus metabolic dysfunction
• ALT elevation (>35 U/L in male and >25 U/L in female) or FIB-4 >=1.45

Exclusion Criteria:

1. diabetes history or HbA1C> 6.5

2. cancer history

3. systolic blood pressure < 100 mmHg

4. eGFR < 30 ml/min/1.73m2

5. history of urinary tract infection/genital yeast infection

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Metabolic Associated Fatty Liver Disease

Intervention

Drug:
• dapagliflozin (Forxiga)
The participants received oral dapagliflozin (Forxiga) 10 mg/day for 24 weeks.

Locations

Country	Name	City	State
Taiwan	Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	New Taipei city
Taiwan	Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of liver inflammatory marker	the change of ALT between baseline and week 24 after treatment	24 weeks
Primary	Change of liver fibrosis markers between baseline and week 24 after treatment	The higher NAFLD fibrosis score (NFS), the more severe liver fibrosis (no maximal or minimal levels)	24 weeks