UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000042507
Receipt number	R000048460
Scientific Title	Prediction model construction of postprandial glycemic responses based on gut microbiome and other personal parameters in Japanese subjects.
Date of disclosure of the study information	2020/11/20
Last modified on	2020/12/22 18:48:27

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Basic information

Public title

Prediction model construction of postprandial glycemic responses based on gut microbiome and other personal parameters in Japanese subjects.

Acronym

Prediction model construction of postprandial glycemic responses based on gut microbiome and other personal parameters in Japanese subjects.

Scientific Title

Prediction model construction of postprandial glycemic responses based on gut microbiome and other personal parameters in Japanese subjects.

Scientific Title:Acronym

Prediction model construction of postprandial glycemic responses based on gut microbiome and other personal parameters in Japanese subjects.

Region

Japan

Condition

Healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

As a proof-of-concept study, we aim to confirm whether the prediction models based on medical and personal parameters and gut microbiome for postprandial glycemic response in Israel and USA can be extrapolated to Japanese volunteers.

Basic objectives2

Others

Basic objectives -Others

Overseas studies reported the effectiveness of the diet therapy based on the algorithm involving medical and personal parameters including gut microbiome analysis. However, it has also been reported that the gut microbiome of Japanese population is different from that of the populations in Europe and America, and it is unclear whether similar results can be obtained in Japan6). The medical economic benefits from the dietary therapy based on gut microbiome and personal parameters algorithm analysis can be expected to be very large, if it is similarly effective in Japan. In this study, we plan to confirm whether there are differences in the relation in measured blood glucose levels and results of predicted blood glucose level generated with the algorithm established in Israel and the USA by analyzing medical and personal parameters including the gut microbiome of the subjects and obtaining data of continuous blood glucose levels while recording meals for about two weeks.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Assessment

Primary outcomes

Algorithm analysis with dietary records, personal data (questionnaire), blood glucose data, and gut microbiome data.

Key secondary outcomes

Base

Study type

Observational

Study design

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Japanese volunteers who gave written Informed Consent by the subject's own free will after being fully informed and with understanding about the participation in this study.
2.Japanese volunteers who have HbA1c data collected within 2 weeks prior to study enrolment.
3.Men and women aged 20 to 65 years at the time of Informed Consent.
4.For type 2 diabetic patients, individuals whose antidiabetic drugs are stable for past 3 months and have no plans to change during the study period

Key exclusion criteria

1.Individuals diagnosed with type 1 diabetes mellitus
2.Individuals using super rapid-acting insulin
3.Individuals who have taken antibiotics within the past 3 months (1 month for external medicine) or who are scheduled to take antibiotics during the study period
4.Pregnant or possibly pregnant women
5.Individuals who have received fertility treatment within the past 3 months
6.Individuals who received chemotherapy or radiotherapy within the past 2 years
7.Individuals with active cancer
8.Individuals with chronic gastrointestinal disease
9.Individuals who have undergone gastrectomy or colorectal resection
10.Individuals with severe anemia of Hb <10mg/dL
11.Individuals who are unable to use the food logging application on smartphone or tablet for food logging
12.Individuals who are unable to wear CGM, and will be unable to wear for 2 weeks continuously
13.Other persons considered inappropriate by the physician-in-charge

Target sample size

Research contact person

Name of lead principal investigator

1st name Masahiro

Middle name

Last name Hashiguchi

Organization

Vorpal Technologies K.K

Division name

IVD

Zip code

103-0021

Address

Nihonbashi Muromachi Building 8F, 3-3-16 Nihonbashiishimachi, Chuo-ku, Tokyo

TEL

03-5544-8340

Email

masahiro.hashiguchi@vorpaltechnologies.com

Public contact

Name of contact person

1st name Masahiro

Middle name

Last name Hashiguchi

Organization

Vorpal Technologies K.K

Division name

IVD

Zip code

103-0021

Address

Nihonbashi Muromachi Building 8F, 3-3-16 Nihonbashiishimachi, Chuo-ku, Tokyo

TEL

03-5544-8340

Homepage URL

Email

masahiro.hashiguchi@vorpaltechnologies.com

Sponsor or person

Institute

Vorpal Technologies K.K

Institute

Department

Personal name

Funding Source

Organization

SoftBank Corp.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Seishukai Clinic Ethical Review Board

Address

3-18-5 Mastugaya, Taito-ku, Tokyo

Tel

03-5830-5654

Email

k-sudo@seishukai.or.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団　成守会　はせがわ病院（東京都）

Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 20 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

2020 Year 11 Month 16 Day

Date of IRB

2020 Year 11 Month 17 Day

Anticipated trial start date

2020 Year 11 Month 24 Day

Last follow-up date

2020 Year 12 Month 10 Day

Date of closure to data entry

2020 Year 12 Month 25 Day

Date trial data considered complete

Date analysis concluded

Other

Other related information

In this study, we plan to confirm whether there are differences in the relation in measured blood glucose levels and results of predicted blood glucose level generated with the algorithm established in Israel and the USA by analyzing medical and personal parameters including the gut microbiome of the subjects and obtaining data of continuous blood glucose levels while recording meals for about two weeks.

Management information

Registered date

2020 Year 11 Month 20 Day

Last modified on

2020 Year 12 Month 22 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048460

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name