Diabetic patients with chronic liver disease
Conditions
Sponsors
Kitasato University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with diabetes 2. Patients diagnosed with liver cirrhosis 3. Patients judged to have indications to use SGLT 2 inhibitors under normal medical treatment 4. Patients with HbA1c (NGSP) of 6.5% or more and 10% or less 5. Male and female aged 20 years or over at the time of agreement acquisition
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes 2. Patients with severe ketosis or diabetic coma 3. Patients with diabetes insidious 4 Patients with Estimated Glomerular Filtration Rate (eGFR) of 45 mL / min / 1.73 m ^ 2 or less 5. Patients with malignancy 6. Patients with end-stage liver failure who have hepatic ascites, child-Pugh class BC and hepatic encephalopathy 7. Pregnant women or patients with potential pregnancy 8. Patients who research managers judged inappropriate as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in HbA1c after 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Change in body weight after 24 weeks of treatment 2 Change in T-cho, LDL, HDL, TG after 24 weeks of treatment. 3 Change in liver enzyme after 24 weeks of treatment. 4 Change in skeletal muscle mass after 24 weeks of treatment. 5 Safety. | — |
Countries
Japan
Contacts
Public ContactUojima Haruki
Kitasato University School of Medicine Department of Gastroenterology, Internal Medicine
Outcome results
None listed