Unique ID issued by UMIN | UMIN000049426 |
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Receipt number | R000056262 |
Scientific Title | Study to evaluate intestinal glucose excretion using 18F-FDG-PET/MR Enterography in patients taking imeglimin |
Date of disclosure of the study information | 2022/12/01 |
Last modified on | 2022/11/04 10:14:03 |
Study to evaluate intestinal glucose excretion using 18F-FDG-PET/MR Enterography in patients taking imeglimin
Imeglimin PET/MRE study with imeglimin
Study to evaluate intestinal glucose excretion using 18F-FDG-PET/MR Enterography in patients taking imeglimin
PET/MRE study with imeglimin
Japan |
type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
Imeglimin, which has a similar chemical structure to metformin, reveals whether or not glucose excretion into the intestinal tract, comparable to metformin.
Bio-equivalence
FDG excretion into the intestinal tract by 18F-FDG-PET/MRE
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Prevention
Medicine |
PET/MRE scan in patients with imeglimin
PET/MRI scan in patients with imeglimin and metformin
20 | years-old | <= |
75 | years-old | > |
Male and Female
1. type 2 diabetic patients
2. patients who have taken imeglimin or imeglimin and metformin for more than 1 month at the time of consent and are expected to take imeglimin
until the date of PET/MRE examination
3. patients with no obvious lesions in the lower gastrointestinal tract
4. patients who are 20 years old or older at the time of consent
5. patients who have obtained written consent from the patient
1. patients with the following contraindications to Buscopan (butyl scopolamine bromide)
patients with hemorrhagic colitis
patients with angle-closure glaucoma
patients with dysuria due to prostatic hypertrophy
patients with severe heart disease
patients with anesthetic ileus
patients with a history of hypersensitivity to this drug
2. patients with dementia or psychiatric disorders
3. patients with possible intestinal perforation or obstruction
4. patients with metals in the body that cannot be tested by PET/MRE
5. pregnant or lactating patients
6. other patients who are judged unsuitable for this study by the investigator
10
1st name | Kazuhiko |
Middle name | |
Last name | Sakaguchi |
Kobe University
Department of Diabetes and Endocrinology
650-0017
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
1st name | Kazuhiko |
Middle name | |
Last name | Sakaguchi |
Kobe University
Department of Diabetes and Endocrinology
650-0017
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
Kobe University
Japan Society for the Promotion of Science
Japanese Governmental office
Intervention research ethics review committee of Kobe University Hospital
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
0783826669
kainyu@med.kobe-u.ac.jp
NO
2022 | Year | 12 | Month | 01 | Day |
Unpublished
Preinitiation
2022 | Year | 11 | Month | 02 | Day |
2022 | Year | 12 | Month | 25 | Day |
2024 | Year | 03 | Month | 31 | Day |
2022 | Year | 11 | Month | 04 | Day |
2022 | Year | 11 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056262
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