UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028611 |
|---|---|
| Receipt number | R000019833 |
| Scientific Title | Effects of insulin on thermoregulation after sugar intake |
| Date of disclosure of the study information | 2017/08/31 |
| Last modified on | 2022/03/17 15:20:15 |
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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 | 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, 558-8585 Japan
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, 558-8585 Japan
TEL
06-6605-2950
Homepage URL
okazaki@sports.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka city university graduate school of medicine
Institute
Department
Personal name
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
Osaka City University Graduate School of Medicine
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan
Tel
06-6645-3435
okazaki@sports.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
| 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
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
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
| 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=R000019833
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
