UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020988 |
|---|---|
| Receipt number | R000024224 |
| Scientific Title | Development of the assay and estimation methods for antiatherogenic functions of high-density lipoprotein |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2016/02/12 12:56:06 |
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Basic information
Public title
Development of the assay and estimation methods for antiatherogenic functions of high-density lipoprotein
Acronym
Evaluation for antiatherogenic functions of HDL
Scientific Title
Development of the assay and estimation methods for antiatherogenic functions of high-density lipoprotein
Scientific Title:Acronym
Evaluation for antiatherogenic functions of HDL
Region
| Japan |
Condition
Condition
healthy persons
Classification by specialty
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
i) To develop a simplified method for HDL preparation. ii) To develop simplified methods for estimations of anti-inflammatory ability, antioxidant ability, and cholesterol efflux capacity. iii) To develop an overall estimation method for the antiatherogenic function of HDL.
Basic objectives2
Others
Basic objectives -Others
development of analytical methods of HDL functions for clinical laboratories
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
satisfactory correlation between the simplified and the established experimental methods for anti-inflammatory ability, antioxidant ability, and cholesterol efflux capacity of HDL
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
drawing blood
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy person
Key exclusion criteria
unhealthy person
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Tozuka |
Organization
Graduate School of Health Care Sciences, Tokyo Medical and Dental University
Division name
Analytical Laboratory Chemistry
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5374
mtozuka.alc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Tozuka |
Organization
Graduate School of Health Care Sciences, Tokyo Medical and Dental University
Division name
Analytical Laboratory Chemistry
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5374
Homepage URL
mtozuka.alc@tmd.ac.jp
Sponsor or person
Institute
Analytical Laboratory Chemistry, Graduate School of Health Care Sciences, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 12 | Day |
Last modified on
| 2016 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024224
