UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034101
Receipt number 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 20:57:02

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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 or person

Institute

Niigata University

Institute

Department

Personal name



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

Value
https://center6.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