Type 2 diabetes and nonalcoholic fatty liver disease
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Liver fat content >= 5.5% assessed by magnetic resonance imaging; 3. Patients with type 2 diabetes who have been treated with metformin, due to their poor blood sugar control (glycated hemoglobin: 7.0% to 10.0%), are prompted to use other drugs in combination; 4. Body mass index: 24 kg/m2~45 kg/m2; 5. No history of drinking or drinking alcohol equivalent to ethanol <30 g/d for men and <20 g/d for women; 6. Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Evidence of other forms of liver disease, including hepatitis B, hepatitis C, autoimmune hepatitis, drug-induced liver disease found based on exposure and medical history, etc.; 2. Have undergone bariatric surgery or used drugs known to cause hepatic steatosis (amiodarone, valproate, tamoxifen, methotrexate, steroids, etc.); 3. Use or replace anti-diabetic drugs (thiazolidinediones, glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, etc.) that affect liver fat content after the intervention, or use other Sodium-glucose co-transporter-2 inhibitor; 4. HIV positive test; 5. Patients with cardiac insufficiency, renal insufficiency, malignant tumor, pregnancy and lactation, or women and men who wish to become pregnant or have children during the study; 6. Patients with a history of mental illness who cannot cooperate with the research of this project; 7. Those with contraindications to dapagliflozin (recurrent urinary tract or genital infection history, current or previous gangrene, or known allergy to the molecule); 8. Those with contraindications to magnetic resonance imaging (pacemaker, claustrophobia, foreign bodies and ferromagnetic implantable medical devices).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Magnetic Resonance Imaging liver proton density fat fraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pancreatic fat content;Liver function;Renal function;Blood lipid;HbA1c;Fasting insulin;C peptide;Inflammatory marker;Weight;Intestinal flora;Urine microalbumin/creatinine; | — |
Countries
China
Contacts
Xinqiao Hospital of Army Medical University