UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058722 |
|---|---|
| Receipt number | R000067128 |
| Scientific Title | Impact of increased blood flow in the retinal arteriole on vascular function |
| Date of disclosure of the study information | 2025/08/07 |
| Last modified on | 2025/08/07 12:46:48 |
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Basic information
Public title
Impact of increased blood flow in the retinal arteriole on vascular function
Acronym
Relationship between blood flow and vascular function in retinal arteriole
Scientific Title
Impact of increased blood flow in the retinal arteriole on vascular function
Scientific Title:Acronym
Relationship between blood flow and vascular function in retinal arteriole
Region
| Japan |
Condition
Condition
healthy adult males
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether increased retinal blood flow enhances vascular function in retinal arterioles
Basic objectives2
Others
Basic objectives -Others
Observation of physiological responses to physiological stimuli
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ocular blood flow, pulse waveform variables
Key secondary outcomes
Grip strength, respiratory parameters, blood flow velocity in middle cerebral artery, blood pressure, heart rate, intraocular pressure, ocular surface temperature
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
9
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
rest hypercapnia (5%CO2 + 21%O2 + N2 balance)-> (washout)-> handgrip exercise (30% of maximal voluntary contraction)-> (washout)-> warming the periocular area (45 degrees Celsius)
Interventions/Control_2
rest-> warming the periocular area (45 degrees Celsius)-> (washout)-> hypercapnia(5%CO2 + 21%O2 + N2 balance)-> (washout)-> handgrip exercise (30% of maximal voluntary contraction))
Interventions/Control_3
rest-> hypercapnia(5%CO2 + 21%O2 + N2 balance)-> (washout)-> warming the periocular area (45 degrees Celsius)-> (washout)-> handgrip exercise (30% of maximal voluntary contraction))
Interventions/Control_4
rest-> low-intensity handgrip exercise (10% of maximal voluntary contraction)-> (washout)-> mild-intensity handgrip exercise (30% of maximal voluntary contraction)-> (washout)-> high-intensity handgrip exercise (50% of maximal voluntary contraction)
Interventions/Control_5
rest-> mild-intensity handgrip exercise (30% of maximal voluntary contraction)-> (washout)-> high-intensity handgrip exercise (50% of maximal voluntary contraction)-> (washout)-> low-intensity handgrip exercise (10% of maximal voluntary contraction)
Interventions/Control_6
rest-> high-intensity handgrip exercise (50% of maximal voluntary contraction)-> (washout)-> low-intensity handgrip exercise (10% of maximal voluntary contraction)-> (washout)-> mild-intensity handgrip exercise (30% of maximal voluntary contraction)
Interventions/Control_7
rest-> low-level hypercapnia (2%CO2 + 21%O2 + N2 balance)-> (washout)-> mild-level hypercapnia (4%CO2 + 21%O2 + N2 balance)-> (washout)-> high-level hypercapnia (6%CO2 + 21%O2 + N2 balance)
Interventions/Control_8
rest-> mild-level hypercapnia (4%CO2 + 21%O2 + N2 balance)-> (washout)-> high-level hypercapnia (6%CO2 + 21%O2 + N2 balance)-> (washout)-> low-level hypercapnia (2%CO2 + 21%O2 + N2 balance)
Interventions/Control_9
rest-> high-level hypercapnia (6%CO2 + 21%O2 + N2 balance)-> (washout)-> low-level hypercapnia (2%CO2 + 21%O2 + N2 balance)-> (washout)-> mild-level hypercapnia (4%CO2 + 21%O2 + N2 balance)
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adults without chronic disease
Participants who provided informed consent after receiving an explanation of the study protocol
Participants whose lifestyle habits, such as physical activity and dietary intake, do not undergo significant changes on the day before or the day of the experiment
Key exclusion criteria
Participants who have been advised by a physician to refrain from exercise
Participants who have been diagnosed with electrocardiographic abnormalities or heart disease by a physician
Participants who have experienced sudden loss of consciousness or episodes of palpitations
Participants who currently have or have had Kawasaki disease or rheumatic fever
Participants who currently have or have had eye diseases
Participants who have been diagnosed with anemia or received treatment for anemia by a physician
Participants whose compliance with the study protocol is in doubt
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | IKEMURA |
Organization
Kitasato University
Division name
College of Liberal Arts and Sciences
Zip code
252-0373
Address
1-15-1 Kitazato, Minami-ku, Kanagawa
TEL
0427788749
ikemura@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsukasa |
| Middle name | |
| Last name | IKEMURA |
Organization
Kitasato University
Division name
College of Liberal Arts and Sciences
Zip code
252-0373
Address
1-15-1 Kitazato, Minami-ku, Kanagawa
TEL
0427788749
Homepage URL
ikemura@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato Institute Research Support Center
Address
1-15-1 Kitazato, Minami-ku, Kanagawa
Tel
042-778-9757
kenkyu@kitasato-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 07 | 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
| 2025 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067128
