Unique ID issued by UMIN | UMIN000040611 |
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Receipt number | R000046345 |
Scientific Title | Long-term effects of ipragliflozin on nonalcoholic fatty liver disease in patients with type 2 diabetes |
Date of disclosure of the study information | 2020/06/01 |
Last modified on | 2022/10/29 06:26:05 |
Long-term effects of ipragliflozin on nonalcoholic fatty liver disease in patients with type 2 diabetes
Long-term effects of ipragliflozin on NAFLD in patients with type 2 diabetes
Long-term effects of ipragliflozin on nonalcoholic fatty liver disease in patients with type 2 diabetes
Long-term effects of ipragliflozin on NAFLD in patients with type 2 diabetes
Japan |
Type 2 diabetes complicated by NAFLD
Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Others
NO
The aim of this study is to examine the long-term effects of ipragliflozin on the hepatic steatosis, visceral/subcutaneous fat volume and glycemic control in patients with type 2 diabetes complicated by NAFLD.
Efficacy
Change from baseline in liver-to-spleen attenuation ratio (L/S ratio) by CT at 5 years
Changes from baseline in AST, ALT, HbA1c, fasting plasma glucose, adiponectin, body weight, abdominal visceral adipose tissue, and subcutaneous adipose tissue at 5 years.
Observational
20 | years-old | <= |
75 | years-old | > |
Male and Female
1. Type 2 diabetic patients
2. HbA1c higher than 7.0% and lower than 11.0%
3. BMI lower than 45 kg/m2
4. Patients who have been treated diet/exercise therapy alone, or patients treated with oral anti-diabetic drugs without SGLT2 inhibitor and thiazolidinedione, and/or insulin therapy at baseline.
5. Patients with NAFLD is suspected by abdominal CT, echo or clinical laboratory tests.
6. Patients who are able to provide written informed consent.
1. Patients who have history or current serious diabetic complication.
2. Patients that insulin dependence is suspected.
3. Patients who have history or current cardiac failure (New York Heart Association Class III or IV), myocardial infarction or cerebrovascular disorder.
4. Patients whose eGFR lower than 45 mL/min/1.73m2, serum creatinine higher than 1.5 mg/dL.
60
1st name | Daisuke |
Middle name | |
Last name | Ito |
Ogawa Red Cross Hospital
Department of Internal Medicine
355-0397
1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
0493-72-2333
dito@saitama-med.ac.jp
1st name | Daisuke |
Middle name | |
Last name | Ito |
Ogawa Red Cross Hospital
Department of Internal Medicine
355-0397
1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
0493-72-2333
dito@saitama-med.ac.jp
Ogawa Red Cross Hospital
Ogawa Red Cross Hospital
Self funding
Ogawa Red Cross Hospital
1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
0493-72-2333
dito@saitama-med.ac.jp
NO
2020 | Year | 06 | Month | 01 | Day |
Unpublished
66
Delay expected |
Because it takes time to collect and analyze data.
No longer recruiting
2015 | Year | 03 | Month | 01 | Day |
2020 | Year | 05 | Month | 08 | Day |
2015 | Year | 03 | Month | 21 | Day |
2021 | Year | 03 | Month | 31 | Day |
Ipragliflozin 50 mg per day or pioglitazone 15-30 mg per day for 24 weeks.
After intervention therapy, patients returned to hospital based diabetes care according to their clinical needs.
2020 | Year | 06 | Month | 01 | Day |
2022 | Year | 10 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046345
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