Unique ID issued by UMIN | UMIN000024822 |
---|---|
Receipt number | R000026978 |
Scientific Title | Effect of SGLT2 inhibitor on energy metabolism in patients with type 2 diabetes |
Date of disclosure of the study information | 2017/01/01 |
Last modified on | 2022/07/31 16:59:37 |
Effect of SGLT2 inhibitor on energy metabolism in patients with type 2 diabetes
Effect of SGLT2 inhibitor on energy metabolism in patients with type 2 diabetes
Effect of SGLT2 inhibitor on energy metabolism in patients with type 2 diabetes
Effect of SGLT2 inhibitor on energy metabolism in patients with type 2 diabetes
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To evaluate changes in energy metabolism after administration of SGLT2 inhibitor in patients with type 2 diabetes
Efficacy
Changes in hepatocellular adenosine triphosphate (ATP) concentrations from baseline
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
3
Treatment
Medicine |
SGLT2 innhibitor: once-daily SGLT2 inhibitor (dapagliflozin 5mg) as add-on to the conventional treatment for 1 week.
Low-carbo diet: low-carbo (40-45%) diet as add-on to the conventional treatment for 1 week.
Control: conventional (55-60% carbohydrate) diet treatment (control) for 1 week.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Inclusion Criteria are type 2 diabetes, age between 20 and 80 years, and BMI>20
Exclusion criteria are type 1 diabetes, secondary diabetes, severe ketosis, diabetic coma or pre-coma patients, alcoholism, severe depression or other psychological condition, malignancy, viral hepatitis, severe liver dysfunction, abnormal hemoglobinemia, severe infections diseases, pre- or post-surger, severe traumatic injury, contraindication for MRI like having metal pieces embedded in the body, pregnant or lactating woman, renal deficiency(eGFR<45mL/min/1.73m2), history of hypersensitivity to dapagliflozin, and those who are not considered to be suitable by an attending physician.
100
1st name | Yoshihito |
Middle name | |
Last name | Fujita |
Kyoto University Graduate School of Medicine
Department of Diabetes, Endocrinology and Nutrition
6068507
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
075-751-3560
yfujita9@kuhp.kyoto-u.ac.jp
1st name | Hospital |
Middle name | |
Last name | Kyoto University Hospital |
General Affairs Division
Research Promotion Unit
6068507
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
075-751-4899
trans@kuhp.kyoto-u.ac.jp
Kyoto University Graduate School of Medicine
AstraZeneca K.K. and Ono Pharmaceutical CO., LTD.
Profit organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Konoecho, Yoshida, Sakyo-ku Kyoto
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
NO
2017 | Year | 01 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 09 | Month | 21 | Day |
2017 | Year | 03 | Month | 01 | Day |
2017 | Year | 12 | Month | 01 | Day |
2020 | Year | 03 | Month | 31 | Day |
2016 | Year | 11 | Month | 14 | Day |
2022 | Year | 07 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026978