UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044504 |
|---|---|
| Receipt number | R000050843 |
| Scientific Title | The effects of difference of water level on renal artery blood flow in sitting position at rest among healthy young adults. |
| Date of disclosure of the study information | 2021/06/11 |
| Last modified on | 2024/12/19 09:17:25 |
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Basic information
Public title
The effects of difference of water level on renal artery blood flow in sitting position at rest among healthy young adults.
Acronym
The effects of difference of water level on renal artery blood flow in sitting position at rest among healthy young adults.
Scientific Title
The effects of difference of water level on renal artery blood flow in sitting position at rest among healthy young adults.
Scientific Title:Acronym
The effects of difference of water level on renal artery blood flow in sitting position at rest among healthy young adults.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of difference of water level on renal artery blood flow in sitting position at rest among healthy young adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
renal artery blood flow indices (blood flow velocity: MnV, mean blood flow velocity: Vm, and blood vessel resistant index: RI)
Key secondary outcomes
Blood pressure, heart rate, cardiac autonomic nervous system activity, body height, body weight, body mass index, body fat percentage, muscle percentage, abdominal circumference
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
| Other |
Interventions/Control_1
Sitting position at rest on land > in water (trochanter major level) > (xiphoid process) > (incisure jugularis)
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have been diagnosed as having no abnormalities in ECG or kidneys in the physical examination (according to the subject's self-report) and have agreed to the purpose of this study.
Key exclusion criteria
1) Those who have been diagnosed with cardiovascular or renal diseases in the physical examination, 2) Those who have lower limb locomotor disorder and have difficulty entering the water tank used in this study, 3) Smokers, 4) Those who have allergic reactions to zinc (acrylic synthetic fiber) and alcohol, 5) Those who have been confirmed to have an adrenal artery with the same diameter as the main renal artery.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | ONO |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2, Tomogaoka, Suma, Kobe-city
TEL
0787964582
onoku@tiger.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | ONO |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2, Tomogaoka, Suma, Kobe-city
TEL
0787964582
Homepage URL
onoku@tiger.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
Kobe University Graduate School of Health Sciences, Health Sciences Ethical Committee
Address
7-10-2 Tomogaoka, Suma, Kobe-shi, Hyogo
Tel
0787964502
syomu2@ams.kobe-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
| 2021 | Year | 06 | Month | 11 | 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
45
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 06 | Month | 11 | Day |
Last modified on
| 2024 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050843
