UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048828 |
|---|---|
| Receipt number | R000055629 |
| Scientific Title | Exploratory research on genetic factors in the metabolism and mechanism of action of citrulline involved in vascular aging |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2023/03/23 10:22:36 |
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Basic information
Public title
Exploratory research on genetic factors in the metabolism and mechanism of action of citrulline involved in vascular aging
Acronym
Exploratory research on genetic factors involved in vascular aging
Scientific Title
Exploratory research on genetic factors in the metabolism and mechanism of action of citrulline involved in vascular aging
Scientific Title:Acronym
Exploratory research on genetic factors involved in vascular aging
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to examine the relationship between the subjective symptoms involved in vascular aging and genetic factors on citrulline metabolism and mechanism of action.
Basic objectives2
Others
Basic objectives -Others
The association between subjective symptoms involved in vascular aging and genetic factors in citrulline metabolism and mechanism of action will be examined by genome-wide analysis in a cross-sectional study.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Target analysis; Relationship between DNA polymorphisms on citrulline metabolism and mechanism of action and questionnaire data
Key secondary outcomes
Genome-wide association study (GWAS); Research for DNA polymorphisms associated with questionnaire data
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Men and women who are 40 years old or older at the time of obtaining consent to participate in the exam
2) Subjects who have been already obtained written consent to participate in the MYCODE research
3) Subjects who have been already obtained the MYCODE research results
4) Subjects who have a briefing of the content of the present study, fully understanding and agreeing to its objective and are able to provide a written informed consent
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoneyama |
Organization
DeNA Life Science, Inc
Division name
Member of the Board
Zip code
150-6140
Address
2-24-12, Shibuya, Shibuya-ku, Tokyo
TEL
03-4366-7219
IRB_dis@dena.com
Public contact
Name of contact person
| 1st name | Ryuichiro |
| Middle name | |
| Last name | Kurata |
Organization
DeNA Life Science, Inc
Division name
MYCODE service Dept
Zip code
150-6140
Address
2-24-12, Shibuya, Shibuya-ku, Tokyo
TEL
03-4366-7219
Homepage URL
IRB_dis@dena.com
Sponsor or person
Institute
DeNA Life Science Inc.
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kirin Holdings Company, Limited
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of DeNA Life Science, Inc
Address
2-24-12, Shibuya, Shibuya-ku, Tokyo
Tel
03-4366-7219
IRB_dis@dena.com
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to explore the relationship between the subjective symptoms involved in vascular aging and genetic factors on citrulline metabolism and mechanism of action.
Management information
Registered date
| 2022 | Year | 09 | Month | 02 | Day |
Last modified on
| 2023 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055629
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
