Unique ID issued by UMIN | UMIN000018166 |
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Receipt number | R000021037 |
Scientific Title | Efficacy and safety in SGLT2 inhibitor for diabetes complicated by non-alcoholic fatty liver disease. |
Date of disclosure of the study information | 2015/07/02 |
Last modified on | 2022/08/25 16:24:24 |
Efficacy and safety in SGLT2 inhibitor for diabetes complicated by non-alcoholic fatty liver disease.
SGLT2 inhibitor for diabetes complicated by NAFLD.
Efficacy and safety in SGLT2 inhibitor for diabetes complicated by non-alcoholic fatty liver disease.
SGLT2 inhibitor for diabetes complicated by NAFLD.
Japan |
Type 2 diabetes complicated by non-alcoholic fatty liver disease
Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Others
NO
The aim of this study is to evaluate the efficacy and safety in SGLT2 inhibitor for diabetes complicated by NAFLD.
Safety,Efficacy
Histologial changes of liver and safety of treament are evaluated at two points of the baseline and 24 weeks after the start of treatment.
Fasting plasma glucose, hemoglobin A1c, aspartate aminotransferase, alanine aminotransferase, and body composition are evaluated at two points of the baseline and 24 weeks after the start of treatment.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
SGLT2 inhibitor is administered orally for 24 weeks or more.
20 | years-old | <= |
64 | years-old | >= |
Male and Female
Type 2 diabetes with liver dysfunction, and/or fatty liver diagnosed by abdominal ultrasonography.
Contraindication for SGLT2 inhibitor.
Ineligible patients by judgement of family doctor.
15
1st name | Norio |
Middle name | |
Last name | Akuta |
Toranomon Hospital
Hepatology
213-0015
1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-0015, Japan
044-877-5111
norioakuta@toranomon.gr.jp
1st name | Norio |
Middle name | |
Last name | Akuta |
Toranomon Hospital
Hepatology
213-0015
1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-0015, Japan
044-877-5111
norioakuta@toranomon.gr.jp
Toranomon Hospital, Department of Hepatology
None
Self funding
Toranomon Hospital institutional review board
2-2-2 Toranomon, Minato-ku, Tokyo, Japan
03-3588-1111
chiken-jim@toranomon.gr.jp
NO
2015 | Year | 07 | Month | 02 | Day |
Partially published
Enrolling by invitation
2015 | Year | 10 | Month | 21 | Day |
2015 | Year | 10 | Month | 21 | Day |
2015 | Year | 10 | Month | 21 | Day |
2027 | Year | 12 | Month | 31 | Day |
2015 | Year | 07 | Month | 02 | Day |
2022 | Year | 08 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021037
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