Type 2 Diabetes Mellitus
Conditions
Interventions
Test Group:SGLT2 inhibitor 10 mg/day, oral
Control Group:Repaglinide 100 mg/day, oral
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for type 2 diabetes mellitus as defined by the WHO or ADA, with a disease duration of no more than 1 year. 2. With comorbid fatty liver disease (MRI-PDFF >=5%). 3. BMI>=25 kg/m^2; 4. Age: 18-75 years; 5. Managed by lifestyle modification alone, with no prior use of glucose-lowering medication. 6. No prior use of hepatoprotective agents.
Exclusion criteria
Exclusion criteria: 1. Other etiologies of fatty liver disease: alcoholic liver disease (alcohol consumption >30 g/day in males or >20 g/day in females), viral hepatitis, or drug-induced liver injury. 2. Significant hepatic or renal dysfunction; gastrointestinal disorders; or acute complications. 3. Subjects with a history of suspected or confirmed alcohol/substance abuse, or any other medical or psychosocial condition deemed by the investigator to be likely to reduce enrollment potential or complicate study participation. 4. Any other condition for which the subject is considered an unsuitable candidate at the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver fat content (MRI-PDFF); | — |
Secondary
| Measure | Time frame |
|---|---|
| Ketone body metabolism-related biomarkers (ß-hydroxybutyrate, BDH1, CPT-1);Liver enzymes (ALT, AST);Liver fibrosis biomarkers (PCIII, IV-C, LN, HA);Body composition (BIA);Fasting plasma glucose (FPG);Hemoglobin A1c (HbA1c);Lipid profile (four components);Fasting insulin;C-peptide;Inflammatory cytokines (IL-6, TNF-a);Safety outcomes (including adverse event recording); | — |
Countries
China
Contacts
Public ContactLi Peicheng
Shanghai East Hospital
Outcome results
None listed