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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034101
Receipt No. R000038878
Scientific Title Mechanisms of sweat gland function associated with adrenergic system in athletes
Date of disclosure of the study information 2018/09/13
Last modified on 2020/09/25

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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/ctr_e/ctr_view.cgi?recptno=R000038878

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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