UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021533 |
|---|---|
| Receipt number | R000024829 |
| Scientific Title | Role of oxidized LDL generation and activation of neutrophils in atherosclerotic lesion formation. |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2022/03/24 10:54:32 |
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Basic information
Public title
Role of oxidized LDL generation and activation of neutrophils in atherosclerotic lesion formation.
Acronym
oxLDL and PMN activation
Scientific Title
Role of oxidized LDL generation and activation of neutrophils in atherosclerotic lesion formation.
Scientific Title:Acronym
oxLDL and PMN activation
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to clarify participation of oxidized LDL in activation of human neutrophils.
Basic objectives2
Others
Basic objectives -Others
Exploring a factor involved in atherogenesis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activation of neutrophils.
Formation of NETs (neutrophil extracellular traps).
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
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers based on informed consent.
Key exclusion criteria
Any healthy volunteers who were drawn blood samples within one month will be excluded.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Itabe |
Organization
Showa University
Division name
Division of Biological Chemistry, Department of Pharmaceutical Sciences, School of Pharmacy
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555
TEL
03-3784-8217
h-itabe@pharm.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Obama |
Organization
Showa University
Division name
Division of Biological Chemistry, Department of Pharmaceutical Sciences, School of Pharmacy
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555
TEL
03-3784-8218
Homepage URL
obama@pharm.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Government offices
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Research Administration Center
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
0337848217
surac1@ofc.showa-u.ac.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
昭和大学薬学部（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fimmu.2019.01899/full
Number of participants that the trial has enrolled
Results
Neutrophil extracellular traps (NETs) act both in anti-bacterial function and tissue damages in various diseases. HL-60-derived neutrophils stimulated with PMA for 30min to induce NETs were treated with oxLDL for 2 h. NET formation was enhanced by oxLDL. When the culture media containing NETs were added to human aortic endothelial cell (HAECs), expression of VE-cadherin decreased. These data suggest that oxLDL may enhances NETs formation and promote vascular endothelial damages.
Results date posted
| 2022 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 08 | Month | 09 | Day |
Baseline Characteristics
Healthy volunteer
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The possible role of neutrophils in atherogenesis has not been clarified.
Management information
Registered date
| 2016 | Year | 03 | Month | 18 | Day |
Last modified on
| 2022 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024829
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
