UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039517 |
|---|---|
| Receipt number | R000045062 |
| Scientific Title | Elucidation of a novel mechanism of metformin action through the gastrointestinal tract |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2021/08/24 09:51:03 |
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Basic information
Public title
Elucidation of a novel mechanism of metformin action through the gastrointestinal tract
Acronym
Elucidation of a novel mechanism of metformin action through the gastrointestinal tract
Scientific Title
Elucidation of a novel mechanism of metformin action through the gastrointestinal tract
Scientific Title:Acronym
Elucidation of a novel mechanism of metformin action through the gastrointestinal tract
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Through measuring the amount of glucose excreted into the intestinal lumen by metformin, we aim to elucidate the clinical significance and mechanism of the promotion of glucose secretion into the intestinal lumen by metformin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of excretion of FDG into the intestinal lumen
Key secondary outcomes
Correlation between FDG excretion and various clinical parameters such as HbA1c and blood glucose level
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
At the time of an FDG-PET / MRI examination pre-determined in routine medical care, we additionally take an MR enterography.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with type 2 diabetes
2. Patients taking metformin hydrochloride
3. Patients who have been determined to take an FDG-PET / MRI by routine medical care
4. Patients with no obvious lesions in the lower gastrointestinal tract
5. Patients aged 20 years or older at the time of consent
6. Patients who have given their informed consent to participate in this study
Key exclusion criteria
1. Patients who participated in other clinical trials within 4 months
2. Patients suffering from dementia or psychiatric disorders
3. Patients with possible intestinal perforation or obstruction
4. Other patients judged inappropriate by the person in charge of this study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Internal Medicine Division of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City
TEL
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Ito |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Internal Medicine Division of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City
TEL
078-382-5861
Homepage URL
karen@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE
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
KOBE University Hospital Clinical and Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City
Tel
078-382-6669
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
神戸大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 31 | 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
0
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
Terminated
Date of protocol fixation
| 2020 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 17 | Day |
Last modified on
| 2021 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045062
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
