Effect of Dapagliflozin (Forxiga) on hepatic lipid content and microbiota in patients with nonalcoholic fatty liver disease complicated by type 2 diabetes mellitus
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000030498
- Lead Sponsor
- Tokai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 17
Not provided
1. Patient who have alcohol intake more than 210g/week ethanol for males or 140g/week ethanol for females. 2. Patients diagnosed viral hepatitis, autoimmune hepatitis, primary biliary cholangitis, drug-induced liver disease, biliary disorder, shock liver, hemochromatosis, Wilson's disease, and alpha1-antitrypsin deficiency 3. Patients diagnosed hepatic cirrhosis 4. Patients with a history of diabetic ketoacidosis 5. Type 1 diabetes mellitus or secondary diabetes 6. Serious renal dysfunction (serum Cre 1.3mg/dl or eGFR<45ml/min/1.73m2) 7. Pregnancy or possible pregnancy and breast feeding 8. Patients who had cerebral stroke, cerebral infarction, urinary infection, or genital infection within 12 weeks before giving their consent 9. Patients who had myocardial infarction, angina pectoris or atrial fibrillation 10. Patient with inability to take the drug by mouse 11. History of hypersensitivity to any of the ingredients of the study drug 12. Patient with contraindications to the study drug 13. In addition, when principal investigator or researcher deems inappropriate as a study subject
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the change of hepatic lipid content measured by MRS at 24 weeks after starting trial.
- Secondary Outcome Measures
Name Time Method Evaluation of the change of blood and urine examination at 4,12, and 24 weeks after starting trial. Evaluation of the change of microbiota at 24 weeks after starting trial. Evaluation of the change of body composition measured by InBody at 12 and 24 weeks after starting trial. Evaluation of the change of CAP and LSM measured by Fibroscan at 12 and 24 weeks after starting trial.