UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054227 |
|---|---|
| Receipt number | R000061918 |
| Scientific Title | Study of platelet thrombosis by Hyperglycemia of healthy individuals after intake. |
| Date of disclosure of the study information | 2024/04/24 |
| Last modified on | 2024/04/22 21:31:04 |
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Basic information
Public title
Study of the potential for elevated postprandial blood glucose to cause thrombosis in healthy individuals.
Acronym
Thrombosis risk after eating in healthy individuals
Scientific Title
Study of platelet thrombosis by Hyperglycemia of healthy individuals after intake.
Scientific Title:Acronym
Thrombosis risk after eating in healthy individuals
Region
| Japan |
Condition
Condition
healthy indivisuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will determine the effects of elevated blood glucose following sugar ingestion on platelet thrombus formation in healthy subjects.
Basic objectives2
Others
Basic objectives -Others
We will clarify the effects of conditions that inhibit glucose metabolism (especially ATP synthesis) during hyperglycemia on thrombus formation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The growth of platelet thrombosis on collagen fibrils before and after glucose intake is observed by using a fluorescence microscope under conditions of blood flow shear rate (1500 s-1) equivalent to human arterial blood flow.
The platelet thrombus is to be evaluated for both the area and fluorescence density of each single thrombus by software Image J.
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
| Food |
Interventions/Control_1
Glucose solution for healthy subjects
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy individuals
Key exclusion criteria
Persons taking antiplatelet drugs.
Persons with high blood glucose levels during fasting.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Tamura |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Nutrition, Faculty of Health Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata, 950-3198 Japan
TEL
0252574478
noriko-tamura@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Tamura |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Nutrition, Faculty of Health Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata, 950-3198 Japan
TEL
0252574478
Homepage URL
noriko-tamura@nuhw.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare Ethics Review Committee
Address
1398 Shimami-cho, Kita-ku, Niigata, 950-3198 Japan
Tel
0252574455
rinri@nuhw.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | 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
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
| 2024 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 04 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061918
| Research Plan | |
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| 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 |
