UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017154 |
|---|---|
| Receipt number | R000019899 |
| Scientific Title | Effects on glucose loading on cerebral glucose metabolism |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2016/05/06 15:16:03 |
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Basic information
Public title
Effects on glucose loading on cerebral glucose metabolism
Acronym
Effects on glucose loading on cerebral glucose metabolism
Scientific Title
Effects on glucose loading on cerebral glucose metabolism
Scientific Title:Acronym
Effects on glucose loading on cerebral glucose metabolism
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the relationships between glucose loading and cerebra glucose metabolism
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in regional glucose metabolism after glucose loading
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration of glucose 75g
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. The subjects who have intention to participate in this study, and signed informed consent.
2. Male and female subjects of >=60 and <90 years, old.
3. The subjects who are healthy
Key exclusion criteria
1. The subjects with a history of brain diseases, excluding than cerebellar diseases.
2. The subjects who are prescribed a medication for the central nervous system.
3. The subject who have chronic dysfunction in the organs.
4. Pregnant or woman who has a chance of pregnant.
5. The subjects who were judged by the clinical investigator to be inappropriate as a participant in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Ishibashi |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Neuroimaging
Zip code
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
ishibashi@pet.tmig.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Ishibashi |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Neuroimaging
Zip code
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
ishibashi@pet.tmig.or.jp
Sponsor or person
Institute
Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology
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
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | 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
| 2015 | Year | 04 | Month | 17 | Day |
Last modified on
| 2016 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019899
