Therapeutic Response of Sodium-glucose Co-transporter Type-2 Inhibitor in Non-diabetic MAFLD Patients: a Pilot Study
- Conditions
- Metabolic Associated Fatty Liver Disease
- Interventions
- Registration Number
- NCT05782972
- Brief 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.
- Detailed 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 & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- diabetes history or HbA1C> 6.5
- cancer history
- systolic blood pressure < 100 mmHg
- eGFR < 30 ml/min/1.73m2
- history of urinary tract infection/genital yeast infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dapagliflozin (Forxiga) treatment dapagliflozin (Forxiga) The participants received oral dapagliflozin (Forxiga) 10 mg/day for 24 weeks
- Primary Outcome Measures
Name Time Method Change of liver inflammatory marker 24 weeks the change of ALT between baseline and week 24 after treatment
Change of liver fibrosis markers between baseline and week 24 after treatment 24 weeks The higher NAFLD fibrosis score (NFS), the more severe liver fibrosis (no maximal or minimal levels)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
🇨🇳New Taipei city, Taiwan