Unique ID issued by UMIN | UMIN000035015 |
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Receipt number | R000039924 |
Scientific Title | Efficacy and safety of sodium-glucose co-transporter (SGLT2) inhibitor in diabetic patients with chronic liver disease |
Date of disclosure of the study information | 2018/11/27 |
Last modified on | 2019/05/05 18:05:50 |
Efficacy and safety of sodium-glucose co-transporter (SGLT2) inhibitor in diabetic patients with chronic liver disease
Efficacy of sodium-glucose co-transporter (SGLT2) inhibitor in chronic liver disease
Efficacy and safety of sodium-glucose co-transporter (SGLT2) inhibitor in diabetic patients with chronic liver disease
Efficacy of sodium-glucose co-transporter (SGLT2) inhibitor in chronic liver disease
Japan |
Diabetic patients with chronic liver disease
Medicine in general |
Others
NO
The purpose of this study is to evaluate safety and efficacy of SGLT2 inhibitor for diabetic patients with liver cirrhosis
Safety,Efficacy
change in HbA1c after 24 weeks of treatment
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
SGLT2 inhibitor is administered once a day for 6 months.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
100
1st name | Haruki |
Middle name | |
Last name | Uojima |
Kitasato University School of Medicine
Department of Gastroenterology, Internal Medicine
252-0373
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
+81-42-778-8111
kiruha@kitasato-u.ac.jp
1st name | Uojima |
Middle name | |
Last name | Haruki |
Kitasato University School of Medicine
Department of Gastroenterology, Internal Medicine
252-0373
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
+81-42-778-8111
kiruha@kitasato-u.ac.jp
Kitasato University School of Medicine
Kitasato University School of Medicine
Self funding
Research Ethics Committee
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
+81-42-778-8111
rinrib@med.kitasato-u.ac.jp
NO
2018 | Year | 11 | Month | 27 | Day |
Unpublished
Open public recruiting
2018 | Year | 10 | Month | 24 | Day |
2018 | Year | 12 | Month | 10 | Day |
2018 | Year | 12 | Month | 10 | Day |
2022 | Year | 04 | Month | 02 | Day |
2018 | Year | 11 | Month | 27 | Day |
2019 | Year | 05 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039924
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