UMIN-CTR Clinical Trial

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
Email	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
Email	okazaki@sports.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033111