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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-11

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Metabolic Associated Fatty Liver Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single-arm, prospective study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dapagliflozin (Forxiga) treatment

The participants received oral dapagliflozin (Forxiga) 10 mg/day for 24 weeks

Group Type EXPERIMENTAL

dapagliflozin (Forxiga)

Intervention Type DRUG

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

Interventions

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dapagliflozin (Forxiga)

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No