Type 2 diabetes mellitus with metabolism-related fatty liver disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Aged between 18 and 70 (including 18 and 70); 2) 19 kg/m2 10%. 5) Willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes or other special types of diabetes; 2) Used more than two kinds of TZDs, GLP-1 receptor agonists, DPP-4 inhibitors, insulin and oral drugs within 3 months; 3) Severe liver injury with ALT and AST more than 3 times the upper limit of normal; 4) Renal impairment, glomerular filtration rate =133µmol/L, male >=135µmol/L; 5) Patients with severe heart disease, such as severe cardiomyopathy, cardiac insufficiency (New York Heart function grade ? or above), acute coronary syndrome, and old myocardial infarction Death or electrocardiogram suggests the diagnosis of the above diseases; 6) Blood pressure: SBP>=180 mmHg and/or DBP>=110 mmHg; 7) White blood cell count <=3.0×109/L or platelet count <=60×10^9/L, or definite anemia (hemoglobin: male < 120 g/L, female < 110 g/L), or other diseases of blood system; 8) Diseases of endocrine system, such as hyperthyroidism, hypothyroidism, hypercortisolism and other diseases affecting fatty liver; 9) Allergic to study drugs or frequent hypoglycemia; 10) Persons suffering from mental disorders, drug or other substance abuse; 11) Patients with diabetic ketoacidosis and hyperosmolar non-ketotic coma need insulin treatment; 12) Chronic hypoxic diseases such as emphysema and cor pulmonale; 13) Combined use of drugs that affect glucose metabolism, such as glucocorticoids; 14) Patients with tumors, especially bladder tumors, and/or a family history of bladder tumors, and/or a long history of hematuria; 15) A history of osteoporosis or non-violent fractures; 16) pregnant or breastfeeding or intending to become pregnant; 17) Have participated in clinical trials of other drugs within three months; 18) Patients deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intrahepatic lipid content (IHL) : the hepatic fat content is detected by magnetic resonance imaging, and the relative fat content of liver cells is expressed by hydrogen proton density fat fraction value (MRI-PDFF).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver Fibrosis score Fibrosis-4 (FIB-4);Glycosylated hemoglobin;Fasting plasma glucose;Fasting insulin;HOMA-IR;Liver enzymes (ALT, AST);subcutaneous adipose tissue;visceral adipose tissue; | — |
Countries
China