UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Active cutaneous vasodilator nerve activity during exercise in humans
Title of the study (Brief title)	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	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
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263-37-2682
Email	yoshikmj@shinshu-u.ac.jp

Public contact
Name of contact person	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
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263-37-2682
Homepage URL
Email	yoshikmj@shinshu-u.ac.jp

Sponsor
Institute	Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention, Shinshu University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014969