UMIN-CTR Clinical Trial

Basic information
Public title	Mechanisms of sweat gland function associated with adrenergic system in athletes
Acronym	Mechanisms of sweat gland function associated with adrenergic system in athletes
Scientific Title	Mechanisms of sweat gland function associated with adrenergic system in athletes
Scientific Title:Acronym	Mechanisms of sweat gland function associated with adrenergic system in athletes
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate a potential adrenergic and cholinergic sweating system during exercise and passive heat stress in habitually trained and untrained adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sweat rate
Key secondary outcomes	Skin blood flow

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Application of adrenergic receptors agonist or antagonist using iontoforesis or microdialysis
Interventions/Control_2	NaCl
Interventions/Control_3	Application of calcium and pottassium channels inhibitors by iontoforesis, 1% concentration
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
Key inclusion criteria	Aged over 20 yrs
Key exclusion criteria	1) Smoker, obese individuals 2) Individuals experienced any cardiovascular disease 3) Individuals with cardiac arrhythmia 4) Individuals with asthma 5) Individuals with gastrointestinal disease 6) Individuals with epilepsy 7) Individuals taking any medications drugs 8) Individuals experienced fainting during blood sampling 9) Individuals who have been considered to exclude the participants based on a researcher
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tatsuro Middle name Last name Amano
Organization	Niigata University
Division name	Faculty of Education
Zip code	950-2181
Address	8050, Igarashi 2, Nishi-ku, Niigata, Niigata
TEL	025-262-7161
Email	amano@ed.niigata-u.ac.jp

Public contact
Name of contact person	1st name Tatsuro Middle name Last name Amano
Organization	Niigata University
Division name	Faculty of Education
Zip code	950-2181
Address	8050, Igarashi 2, Nishi-ku, Niigata, Niigata
TEL	025-262-7161
Homepage URL
Email	amano@ed.niigata-u.ac.jp

Sponsor
Institute	Niigata University
Institute
Department

Funding Source
Organization	JSPS
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	Niigaa University human research ethic committee
Address	1-757 Asahidori, Chuoku, Niigata
Tel	025-227-2625
Email	ethics@adm.niigata-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	2018 Year 09 Month 13 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	Enrolling by invitation
Date of protocol fixation	2018 Year 09 Month 05 Day
Date of IRB	2018 Year 09 Month 05 Day
Anticipated trial start date	2018 Year 09 Month 13 Day
Last follow-up date	2021 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	2018 Year 09 Month 12 Day
Last modified on	2020 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038878