Unique ID issued by UMIN | UMIN000027362 |
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Receipt number | R000031027 |
Scientific Title | Examination of the liver fibrosis improvement effect with the SGLT2 inhibitor for diabetes complicated by non-alcoholic steatohepatitis. |
Date of disclosure of the study information | 2017/05/16 |
Last modified on | 2017/05/26 15:00:09 |
Examination of the liver fibrosis improvement effect with the SGLT2 inhibitor for diabetes complicated by non-alcoholic steatohepatitis.
SGLT2 inhibitor for diabetes complicated by NASH.
Examination of the liver fibrosis improvement effect with the SGLT2 inhibitor for diabetes complicated by non-alcoholic steatohepatitis.
SGLT2 inhibitor for diabetes complicated by NASH.
Japan |
Type 2 diabetes complicated by non-alcoholic fatty liver disease
Medicine in general | Hepato-biliary-pancreatic medicine |
Others
YES
Study of the liver fibrosis improvement effect with the SGLT2 inhibitor for diabetes complicated by NASH
Efficacy
Histologial changes of liver biopsy of treament are evaluated at two points of the baseline and 1 year after the start of treatment.
Fasting plasma glucose, hemoglobin A1c, aspartate aminotransferase, alanine aminotransferase, and liver fibrosis are evaluated at two points of the baseline and 1 year 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 1 year or more.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Type 2 diabetes with liver dysfunction, and NASH diagnosed by liver biopsy.
Contraindication for SGLT2 inhibitor.
Ineligible patients by judgement of family doctor.
30
1st name | |
Middle name | |
Last name | Makoto Irie |
Fukuoka University Hospital
Hepatology
7-45-1 Nanakuma, Johnan-ku, Fukuoka-shi814-0180, Japan
092-801-1011
mirie@fukuoka-u.ac.jp
1st name | |
Middle name | |
Last name | Makoto Irie |
Fukuoka University Hospital
Hepatology
7-45-1 Nanakuma, Johnan-ku, Fukuoka-shi814-0180, Japan
092-801-1011
mirie@fukuoka-u.ac.jp
Fukuoka University Hospital
Fukuoka University Hospital
Other
NO
2017 | Year | 05 | Month | 16 | Day |
Unpublished
Preinitiation
2017 | Year | 04 | Month | 12 | Day |
2017 | Year | 05 | Month | 16 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 04 | Month | 30 | Day |
2017 | Year | 05 | Month | 16 | Day |
2017 | Year | 05 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031027
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