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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026523
Receipt No. 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 2019/03/15

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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
Email 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
Email ryu-th@umin.ac.jp

Sponsor
Institute Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences, Analytical Laboratory Chemistry
Institute
Department

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
Email 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 Enrolling by invitation
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
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030455

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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