Clinical trial NCT05782972: Therapeutic Response of Sodium-glucose Co-transporter Type-2 Inhibitor in Non-diabetic MAFLD Patients: a Pilot Study
Official title: Therapeutic Response of Sodium-glucose Co-transporter Type-2 Inhibitor in Non-diabetic MAFLD Patients: a Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Metabolic Associated Fatty Liver Disease
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm, prospective study
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change of liver inflammatory marker
timeFrame: 24 weeks
measure: Change of liver fibrosis markers between baseline and week 24 after treatment
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei city
country: Taiwan
facility: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study officials:
References: