This exploratory study will assess the efficacy of combined pioglitazone and empagliflozin therapy in improving hepatic and metabolic outcomes in patients with type 2 diabetes mellitus and metabolic dysfunction-associated fatty liver disease (MAFLD). Although each agent has shown beneficial effects individually, evidence on their combined impact on liver health is scarce. This study seeks to determine whether the combination therapy yields additive improvements in hepatic steatosis, inflammation, and fibrosis, potentially offering a new therapeutic strategy for diabetic patients with fatty liver disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Participants will receive pioglitazone 15 mg, administered orally once daily. The tablet may be taken with or without food.
Participants will receive empagliflozin 10 mg, administered orally once daily. The tablet may be taken with or without food.
Participants will receive one tablet of pioglitazone 15 mg and one tablet of empagliflozin 10 mg, administered orally once daily. Both tablets may be taken with or without food.
Seoul National University Bundang Hospital
Seongnam-si, South Korea
RECRUITINGProportion of Participants Achieving HbA1c Treatment Targets
Percentage of participants who achieve the predefined HbA1c treatment goal at 24 weeks.
Time frame: 24 weeks
Change in Fibroscan Controlled Attenuation Parameter (CAP) Score
Assessment of changes in hepatic steatosis as measured by the controlled attenuation parameter (CAP) score using Fibroscan technology over a 24-week period.
Time frame: 24 weeks
Change in HbA1c Levels
Change in glycated hemoglobin (HbA1c) from baseline after 24 weeks of treatment.
Time frame: 24 weeks
Change in Liver Stiffness Measurement
Change in liver stiffness measurement (LSM) assessed using Fibroscan
Time frame: 24 weeks
Change in Non-Invasive Blood-Based Fibrosis Markers
Change in NAFLD score, Fibrosis-4 (FIB-4) index, and AST to Platelet Ratio Index (APRI) over 12 and 24 weeks.
Time frame: 12 weeks, 24 weeks
Change in Anthropometric Measures
Changes in metabolic parameters including body weight, body mass index (BMI), waist circumference
Time frame: 12 weeks, 24 weeks
Change in Lipid Parameters
Changes in blood lipid profile (total cholesterol, LDL-c, HDL-c, triglycerides)
Time frame: 12 weeks, 24 weeks
Change in Liver Function Tests
Change in liver function markers including AST, ALT, gamma-glutamyl transferase (gamma-GT), albumin, bilirubin, and prothrombin time
Time frame: 12 weeks, 24 weeks
Change in Fibrosis Biomarker
Change in serum type IV collagen levels
Time frame: 12 weeks, 24 weeks
Change in Inflammatory Biomarker
Change in high-sensitivity C-reactive protein (hs-CRP) levels
Time frame: 12 weeks, 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.