UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028932 |
|---|---|
| Receipt number | R000033111 |
| Scientific Title | Research on the effects of hyperthermia on physiological responses to hypoxia |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2022/03/17 15:13:04 |
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Basic information
Public title
Research on the effects of hyperthermia on physiological responses to hypoxia
Acronym
Research on the effects of hyperthermia on physiological responses to hypoxia
Scientific Title
Research on the effects of hyperthermia on physiological responses to hypoxia
Scientific Title:Acronym
Research on the effects of hyperthermia on physiological responses to hypoxia
Region
| Japan |
Condition
Condition
Healthy adult males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the the effects of hyperthermia on physiological responses to hypoxia, and to examine the effects of hypoxia on thermoregulatory responses.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
heart rate, blood pressure, arterial oxygen saturation, carotid artery blood flow, plasma erythropoietin concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
| Other |
Interventions/Control_1
3000m simulated altitude (14.4% oxygen) exposure for 3 hours + Hyperthermia (~1.2 C increase in esophageal temperature) for 2 hours
Interventions/Control_2
3000m simulated altitude (14.4% oxygen) exposure for 3 hours + Normothermia for 2 hours
Interventions/Control_3
Normal air exposure for 3 hours + Hyperthermia (~1.2 C increase in esophageal temperature) for 2 hours
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
1) age <= 20 years old to > 40 years old at the time of informed consent
2) volunteers who are fully informed of and understand the objectives, procedures, and possible risks of the study and provide the written voluntary consent to participate in the study.
Key exclusion criteria
1) Diseases which need physical work restriction
2) Cardiovascular diseases, arrhythmia
3) Metabolic and endocrine disease
4) Hypertension (resting blood pressure, SBP > or = 160 mmHg, DBP > or = 100)
5) Smokers
6) Obesity (BIM <= 30 kg/m2)
7) Ineligible by a medical interview
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kazunobu |
| Middle name | |
| Last name | Okazaki |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138 Sugimoto, Sumiyoshi, Osaka
TEL
06-6605-2950
okazaki@sports.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kazunobu |
| Middle name | |
| Last name | Okazaki |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138 Sugimoto, Sumiyoshi, Osaka
TEL
06-6605-2950
Homepage URL
okazaki@sports.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Osaka City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University
Address
1-4-3 Asahi-machi, Abeno, Osaka
Tel
06-6645-3457
ethics@med.osaka-cu.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 | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 29 | 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
| 2017 | Year | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033111
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
