UMIN-CTR Clinical Trial

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