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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000039517
Receipt No. 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

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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
Email 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
Email karen@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045062

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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