UMIN-CTR Clinical Trial

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

Sponsor
Institute	Kobe university
Institute
Department

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
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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049612