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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028611
Receipt No. R000019833
Scientific Title Effects of insulin on thermoregulation after sugar intake
Date of disclosure of the study information 2017/08/31
Last modified on 2019/02/12

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Basic information
Public title Effects of insulin on thermoregulation after sugar intake
Acronym Effects of insulin on thermoregulation after sugar intake
Scientific Title Effects of insulin on thermoregulation after sugar intake
Scientific Title:Acronym Effects of insulin on thermoregulation after sugar intake
Region
Japan

Condition
Condition Target population: Persons with an attenuated thermoregulation under the heat
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the effects of an increased insulin concentration in the brain on thermoregulatory responses in the heat.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcome is thermoregulatory response during 60 minutes of passive heating after sugar ingestion.
Key secondary outcomes Key secondary outcomes are heart rate, blood pressure, oxygen consumption, and blood constituents.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are 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 Intranasal insulin administration
Regular Insulin (Novolin R, 100 IU/mL) is administrated to nares side-to-side by a nasal spray every minute (total 16 times, 160 IU)
Interventions/Control_2 Placebo control
Normal saline is administrated to nares side-to-side by a nasal spray every minute (total 16 times, 160 IU)
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
18 years-old <=
Age-upper limit
39 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adults
Key exclusion criteria Diabetes
Metabolic and endocrine disease
Hypertension (SBP > or = 140 mmHg, DBP > or = 90)
Cardiovascular diseases
Obesity (BMI, males > or = 25 kg/m2, females > or = 30 kg/m2)
Smoking
Conditions difficult to perform measurements
Ineligible by a medical interview
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunobu Okazaki
Organization Osaka city university graduate school of medicine
Division name Environmental physiology for exercise
Zip code
Address 3-3-138 Sugimoto, Sumiyoshi, Osaka, 558-8585 Japan
TEL 06-6605-2950
Email okazaki@sports.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunobu Okazaki
Organization Osaka city university graduate school of medicine
Division name Environmental physiology for exercise
Zip code
Address 3-3-138 Sugimoto, Sumiyoshi, Osaka, 558-8585 Japan
TEL 06-6605-2950
Homepage URL
Email okazaki@sports.osaka-cu.ac.jp

Sponsor
Institute Osaka city university graduate school of medicine
Institute
Department

Funding Source
Organization Osaka city university graduate school of medicine, Environmental Physiology for Exercise
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
Address
Tel
Email

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
2017 Year 08 Month 31 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
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 Completed
Date of protocol fixation
2015 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
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 09 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019833

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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