Type 2 Diabetes Mellitus
Conditions
Interventions
Group A: Administer empagliflozin
Patients in this empagliflozin group take empagliflozin 10 mg once a day orally before or after breakfast, and continue it for 12 weeks.
Group B: Administer sitagl
Sponsors
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Toho University Omori Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1. Type 2 diabetic patients with HbA1c below 10% at the time of consenting 2. Female and male patients are 20 years old or older and younger than 75 years old 3. Patients who can take liver biopsy for the purpose of evaluation or diagnosis of non-alcohol fatty liver disease 4. Patients with BMI 22 kg/m2 or higher 5. Patients who can provide their written consent for participation of this study
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study. 1. Patients with type 1 diabetes or secondary diabetes 2. Patients with BMI lower than 22 kg/m2 3. Patients with moderate to severe renal function disease or at the final stage of renal failure (eGFR lower than 45 mL/min/1.73 m2) 4. Patients who had stroke or cerebral infarction within 12 weeks before giving their consent 5. Patients with any medical history of myocardial infarction, angina pectoris, or currently with atrial fibrillation 6. Patients with any infectious disease 7. Patients with malignancy (However, those who have completed treatment and/or show no redevelopment of malignancy, as well as manifest some degree of remission can be considered to be participants of this study) 8. Patients with connective tissue disease (However, those T2DM patients who have treated with prednisolone 5 mg or less and show stable conditions can be considered to be participants of this study) 9. Patients with hepatocirrhosis 10. Patients with viral or autoimmune, or drug-induced hepatic disorder 11. Patients who are alcoholic or excessive drinkers 12. Patients who are currently pregnant, possibly pregnant, or breast-feeding during the study 13. Patients have a medical history of hypersensitivity to the study drugs 14. Patients who are in the category that the study drugs are prohibited to use 15. Patients with Hb below 12 g/dl 16. Patients with other conditions that investigators/physicians think inappropriate to be in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the following value changed from the baseline and the percent change: * Amount of hepatic lipid accumulation (measured by MRI, Proton MRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the following values changed from the baseline and the percent change: 1. Liver insulin sensitivity (measured by the hyperinsulinemic-euglycemic clamp technique) 2. Muscle, adipose insulin sensitivity (measured by the hyperinsulinemic-euglycemic clamp technique) 3. Hepatic fibrosis index (Type IV collagen 7s, ferritin, PIIIP, hyaluronic acid) 4. Liver gluconeogenesis index (cortisol) 5. Epithelial cell apoptosis index (CK18 fragment) 6. Hepatokine (hepatic hormone ) index (FGF21, Fetuin A) 7.Other index related to liver (Hepatocyte growth factor, insulin-like growth factor 1/IGF-1) 8. Adipose amount (intraperitoneal adipose amount, subcutaneous fat amount) by CT scans 9. Body weight, whole-body adipose amount, fat removal quantity, bone and muscle mass by DEXA scans 10. Physical activity level 11. Scores of the questionnaires answered by patients | — |
Countries
Japan
Outcome results
None listed