UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012811 |
|---|---|
| Receipt number | R000014969 |
| Scientific Title | Active cutaneous vasodilator nerve activity during exercise in humans |
| Date of disclosure of the study information | 2014/07/08 |
| Last modified on | 2018/06/21 17:07:41 |
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Basic information
Public title
Active cutaneous vasodilator nerve activity during exercise in humans
Acronym
Active cutaneous vasodilator during exercise
Scientific Title
Active cutaneous vasodilator nerve activity during exercise in humans
Scientific Title:Acronym
Active cutaneous vasodilator during exercise
Region
| Japan |
Condition
Condition
Heat stroke
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our purpose is to examin whether a component of skin sympathetic nerve activity synchronized with cardiac cycle increaes with an increase in body temperature during exercise and whether rapid saline infusion enhances the component.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Esophageal temperature, skin blood flow and a component of skin sympathetic nerve activity synchronized with cardiac cycle during exercise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Saline infusion at 1.0 ml/kg/min for 10 min and then 0.3 ml/kg/min for 10 min.
Interventions/Control_2
No infusion
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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
healthy and non-smoking males
Key exclusion criteria
ones who have overt history of cardiovascular and respiratory functions, take medicines, and abnormal ECG.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nose, M.D., Ph.D. |
Organization
Shinshu University Graduate School of Medicine
Division name
Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2682
yoshikmj@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshi-ichiro Kamijo, M.D., Ph.D. |
Organization
Shinshu University Graduate School of Medicine
Division name
Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2682
Homepage URL
yoshikmj@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention, Shinshu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
| 2014 | Year | 07 | Month | 08 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 09 | 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
| 2014 | Year | 01 | Month | 10 | Day |
Last modified on
| 2018 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014969
| Research Plan | |
|---|---|
| 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 |
