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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049612


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name