UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045541 |
|---|---|
| Receipt number | R000051981 |
| Scientific Title | Examination of the correlation between blood arginase level and vascular endothelial function and arterial stiffness in healthy adults. |
| Date of disclosure of the study information | 2021/09/24 |
| Last modified on | 2022/09/27 08:18:59 |
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Basic information
Public title
Examination of the correlation between blood arginase level and vascular endothelial function and arterial stiffness in healthy adults.
Acronym
Examination of the correlation between blood arginase level and vascular function.
Scientific Title
Examination of the correlation between blood arginase level and vascular endothelial function and arterial stiffness in healthy adults.
Scientific Title:Acronym
Examination of the correlation between blood arginase level and vascular function.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationship between blood arginase-related factors and the vascular function including vascular endothelial function and arterial stiffness in healthy adults.
Basic objectives2
Others
Basic objectives -Others
The relationship between blood arginase-related factors and the vascular function including vascular endothelial function and arterial stiffness will be evaluated by a cross-sectional study.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood arginase level
Vascular function
Key secondary outcomes
1. Vascular aging
2. Blood analysis
3. Physical measurement
4. Physical examination
5. Stress evaluation
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
| 45 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjects who meet the following criteria
(1) Subjects aged from 40 to 70 years old: Women are limited to postmenopausal (Duration of amenorrhea; >1 y)
(2) Subjects whose blood pressure is within the normal high value (139 mmHg >=SBP or/and 89 mmHg >=DBP)
(3) 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
(1) Subjects who have the history of heart disease, liver disease, kidney disease, respiratory disease, endocrine disease, metabolic disease, or the history of these diseases.
(2) Subjects who have the disease under treatment.
(3) Subjects who regularly use supplements, health food (including foods for specified health use / foods with functional claims) during the test period.
(4) Subjects who take part in another clinical study during the study.
(5) Subjects who are excessively take alcohol (expressed in an amount of alcohol: over 20g/day).
(6) Subjects who have a smoking habit (those who smoke daily or occasionally in the last 3 months)
(7) Subjects who conduct hormone replacement therapy in the 3 months.
(8) Asthma patients
(9) Subjects who regularly exercise (> 120 min / week)
(10) Subjects who are judged by the investigator to be inappropriate as subjects based on the test results at the time of screening
(11) Subjects deemed unsuitable by the investigator for other reasons
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Morita |
Organization
Kirin Holdings Company, Limited
Division name
Research & Development Division, KIRIN Central Research Institute
Zip code
305-0841
Address
2, Miyukigaoka, Tsukuba-shi, Ibaraki, Japan
TEL
090-3063-2127
Masahiko_Morita@kirin.co.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Tomaru |
Organization
Synapse Planning Company, Limited.
Division name
Clinical Trial Session
Zip code
162-0054
Address
5-45-1, Higashinippori, Arakawa-ku, Tokyo, Japan
TEL
03-5604-9442
Homepage URL
tomaru@synaps.co.jp
Sponsor or person
Institute
Kirin Holdings Company, Limited
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Tsukiji Futaba Clinic
Address
Hosokawa Tsukiji Bild. 6th Floor, Tsukiji 1-9-9, Cyuou-ku Tokyo
Tel
03-6226-5812
tohru@hikobae.net
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
東京シーサイドクリニック、医療法人社団成守会 はせがわ病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 24 | 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
124
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 | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 06 | Month | 22 | Day |
Other
Other related information
It has been suggested that blood arginase level in healthy adults may be an early diagnostic marker for arteriosclerosis as well as cardiovascular risks, but no detailed studies have been conducted. Therefore, the purpose of this study is to clarify the relationship between blood arginase level and vascular function including vascular endothelial function and arterial stiffness, which more directly reflects the early stage of arteriosclerosis, in healthy adults.
Management information
Registered date
| 2021 | Year | 09 | Month | 22 | Day |
Last modified on
| 2022 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051981
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