UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030685 |
|---|---|
| Receipt number | R000035037 |
| Scientific Title | Influence of habitual exercise training on sweat gland function |
| Date of disclosure of the study information | 2018/01/05 |
| Last modified on | 2025/01/10 09:22:55 |
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Basic information
Public title
Influence of habitual exercise training on sweat gland function
Acronym
Influence of habitual exercise training on sweat glands function
Scientific Title
Influence of habitual exercise training on sweat gland function
Scientific Title:Acronym
Influence of habitual exercise training on sweat glands function
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate calcitonin gene related peptide-induced amplification of cholinergic sweating in habitually trained and untrained individuals.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local sweat rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Intradermal administration of 1mM to 1M methacholine, 10 to the power of 7 M calcitonin gene related peptide, and 4mM theophylline using intradermal microdialysis technique.
Interventions/Control_2
Same as intervention 1.
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
| Not applicable |
Gender
Male
Key inclusion criteria
1) Aged over 20 yrs
2) Habitually exercise trained or untrained individuals
Key exclusion criteria
1) Obese individuals
2) Smoker
3) Individuals who take prescription medication(s)
4) Individuals who are regarded as inappropriate participation for the study by the investigator.
Target sample size
20
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
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
amano@ed.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
The human ethical committee of Niigata University
Address
1-754, Asahimachidori, Chuoku, Niigata, Japan
Tel
025-368-9345
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
新潟大学（新潟県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 05 | 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
Suspended
Date of protocol fixation
| 2017 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2027 | 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 | 01 | Month | 05 | Day |
Last modified on
| 2025 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035037
