UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026523 |
|---|---|
| Receipt number | R000030455 |
| Scientific Title | Investigation of the role of red blood cell in lipids metabolism. |
| Date of disclosure of the study information | 2017/03/14 |
| Last modified on | 2020/09/15 19:05:09 |
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Basic information
Public title
Investigation of the role of red blood cell in lipids metabolism.
Acronym
The role of red blood cell in lipids metabolism.
Scientific Title
Investigation of the role of red blood cell in lipids metabolism.
Scientific Title:Acronym
The role of red blood cell in lipids metabolism.
Region
| Japan | Australia |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Several studies showed that RBC might also play an important role in reverse cholesterol transport system. Furthermore, apolipoprotein B (apoB), which is main component of low density lipoprotein, is bound to the surface of RBC and patients with atherosclerosis have lower RBC-bound apoB. Thus, RBC might affect lipids metabolism and associate with the progression of atherosclerosis, however the relationship between RBC and lipids metabolism has not been elucidated. Therefore, the aim of this study is to investigate the involvement of RBC in lipids metabolism.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analyzing the lipoprotein profiles in plasma after treating with RBC.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Maximum allowable volume in one blood draw is 30 mL. Collection from one person may not occur more frequently than 1 time per month and 9 times per year.
*In Baker IDI Heart and Diabetes institute, the maximum allowable volume in one blood draw is 20 mL. Collection from one person may not occur more frequently than 1 time per month. Residual sample and sample which is provided from red cross are also used.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Adult
Key exclusion criteria
Patient
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Tozuka |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Medical and Dental Sciences, Analytical Laboratory Chemistry
Zip code
1138519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
+81-3-5803-5374
mtozuka.alc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Ryunosuke |
| Middle name | |
| Last name | Ohkawa |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Medical and Dental Sciences, Analytical Laboratory Chemistry
Zip code
1138519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
+81-3-5803-5375
Homepage URL
ryu-th@umin.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences, Analytical Laboratory Chemistry
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Baker Heart and Diabetes Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of the Faculty of Medicine, Tokyo Medial and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
+61-3-9076-3619
info.bec@tmd.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
M2000-1790
Org. issuing International ID_1
The ethics committee of Tokyo Medical and Dental University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医科歯科大学大学院医歯学総合研究科先端分析検査学分野
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 14 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 13 | Day |
Last modified on
| 2020 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030455
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| Registered date | File name |
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