Type 2 diabetes mellitus with metabolic dysfunction-associated fatty liver disease (MAFLD)
Conditions
Interventions
Experimental Group 1:Pioglitazone–metformin
Experimental Group 2:Ganagliflozin proline
Control Group:Metformin
Sponsors
The First People's Hospital of Changzhou
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients who meet the diagnostic criteria for type 2 diabetes mellitus (T2DM) and metabolic dysfunction-associated fatty liver disease (MAFLD). 2.Age >=30 years and =6% and =248 dB/m measured by transient elastography.
Exclusion criteria
Exclusion criteria: 1.Use of any medications associated with hepatic steatosis within 3 months prior to screening, including but not limited to glucocorticoids, tamoxifen, amiodarone, methotrexate, or other hepatotoxic drugs. 2.Plasma levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin greater than 2.5 times the upper limit of normal (ULN). 3.Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m^2. 4.Diagnosis of congestive heart failure, New York Heart Association (NYHA) class III–IV. 5.History of any liver disease, including autoimmune liver disease, viral hepatitis, or hepatocellular carcinoma. 6.Known allergy or hypersensitivity to ganagliflozin, pioglitazone–metformin, or any of their components. 7.Ongoing symptomatic urinary tract infection. 8.Pregnant or lactating women, or those planning pregnancy within 12 months. 9.Presence of malignancy or other severe systemic diseases. 10.Any other condition that, in the investigator’s judgment, would make the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the controlled attenuation parameter (CAP) from baseline to week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the fibrosis-4 (FIB-4) index from baseline to week 24;Changes in liver function parameters (ALT, AST, and ?-GT);Change in glycemic and lipid metabolic parameters (fasting plasma glucose, HbA1c, and blood lipids) from baseline to week 24;Change in liver stiffness measurement (LSM) from baseline to week 24;Adverse event occurrence; | — |
Countries
China
Contacts
Public ContactLong Wang; Jing Zhu
The First People's Hospital of Changzhou
Outcome results
None listed