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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042507
Receipt No. 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 2020/11/20

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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
Condition Healthy person
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

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 57

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
Institute Vorpal Technologies K.K
Institute
Department

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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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 Preinitiation
Date of protocol fixation
2020 Year 11 Month 16 Day
Date of IRB
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
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 11 Month 20 Day


Link to view the page
URL(English) https://upload.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


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