UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014153 |
|---|---|
| Receipt number | R000016481 |
| Scientific Title | The effects of brain insulin signaling and exercise on incretin secretion, gastric emptying and appetite. |
| Date of disclosure of the study information | 2014/06/16 |
| Last modified on | 2016/06/16 10:29:57 |
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Basic information
Public title
The effects of brain insulin signaling and exercise on incretin secretion, gastric emptying and appetite.
Acronym
The effects of brain insulin signaling and exercise on incretin secretion, gastric emptying and appetite.
Scientific Title
The effects of brain insulin signaling and exercise on incretin secretion, gastric emptying and appetite.
Scientific Title:Acronym
The effects of brain insulin signaling and exercise on incretin secretion, gastric emptying and appetite.
Region
| Japan |
Condition
Condition
diabetes
obesity
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine the hypothesis that brain insulin administration via olfactory nerve and a bout of exercise increase the incretin secretion followed by delayed gastric emptying and decreased appetite
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plasma GLP-1 concentration
gastric half-emptying time (T50%)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
intranasal insulin administration
Interventions/Control_2
intranasal placebo (normal saline solution) administration
Interventions/Control_3
a bout of exercise
Interventions/Control_4
no exercise
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adults
Key exclusion criteria
subjects with arrhythmia, ischemic heart disease, chronic heart failure, hypertension (BP is 140mmHg or over in systolic, or 90mmHg or over in diastolic), diabetes, or obesity (BMI is 30 or more)
subjects who are judged by a doctor to be inappropriate for participating in the exercise test
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisayo Yokoyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL
06-6605-2947
yokoyama@sports.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisayo Yokoyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL
06-6605-2947
Homepage URL
yokoyama@sports.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine, Environmental Physiology for Exercise
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
Address
Tel
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
| 2014 | Year | 06 | Month | 16 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 16 | 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
| 2014 | Year | 06 | Month | 03 | Day |
Last modified on
| 2016 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016481
| Research Plan | |
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| 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 |
