UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043446 |
|---|---|
| Receipt number | R000049612 |
| Scientific Title | A study to evaluate the excretory dynamics of intestinal fluorodeoxyglucose(FDG) in patients taking metformin using continuous imaging of 18F-FDG-PET/MRI |
| Date of disclosure of the study information | 2021/02/26 |
| Last modified on | 2022/11/01 13:23:10 |
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Basic information
Public title
A study to evaluate the excretory dynamics of intestinal fluorodeoxyglucose(FDG) by metformin using continuous imaging of 18F-FDG-PET/MRI
Acronym
A study to evaluate the excretory dynamics of intestinal FDG by metformin using PET/MRI
Scientific Title
A study to evaluate the excretory dynamics of intestinal fluorodeoxyglucose(FDG) in patients taking metformin using continuous imaging of 18F-FDG-PET/MRI
Scientific Title:Acronym
A study to evaluate the excretory dynamics of intestinal FDG in patients taking metformin using continuous PET/MRI
Region
| Japan |
Condition
Condition
patients with type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the site of the excretion pathway of fluorodeoxyglucose(FDG) in the intestinal tract
Basic objectives2
Others
Basic objectives -Others
Evaluate the correlation between the glucose excretion pathway promoted by metformin and the clinical parameters of HbA1c, blood glucose level, biochemical test items, and background factors of the study subjects
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
site of excretion pathway in the intestinal tract of fluorodeoxyglucose(FDG)
Key secondary outcomes
Clinical parameters of HbA1c, blood glucose level, biochemical test items, background factors of study subjects
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
PET/MRI examination for patients taking metformin
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with type 2 diabets
(2) Patients taking moore than 1000 mg of metformin per day last month or more
(3) Patients with no obvious lesions in the lower gastrointestinal tract
(4) Age more than 20 years old
(5) Patients who have given their voluntary written consent to participate in this clinical study
Key exclusion criteria
(1) Patients who participated in other clinical trials within 3 months prior to obtaining consent
(2) Patients suffering from dementia or mental illness
(3) Patients with possible bowel perforation or obstruction
(4) Patients with metals in the body that are not amenable to PET/MRI testing
(5) Pregnant or breast feeding patients
(6) Other patients who are deemed inappropriate by the investigators of this clinical study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kobe university
Division name
Department of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
TEL
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kobe university
Division name
Department of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
TEL
078-382-5861
Homepage URL
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university
Institute
Department
Personal name
Funding Source
Organization
Manpei Suzuki Diabetes Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Kobe university
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
Tel
0783826669
kainyu@med.kobe-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 11 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 26 | Day |
Last modified on
| 2022 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049612
