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
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
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
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
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
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
