UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects on glucose loading on cerebral glucose metabolism
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kenji Ishibashi
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Research Team for Neuroimaging
Address	35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL	03-3964-3241
Email	ishibashi@pet.tmig.or.jp

Public contact
Name of contact person	Kenji Ishibashi
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Research Team for Neuroimaging
Address	35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL	03-3964-3241
Homepage URL
Email	ishibashi@pet.tmig.or.jp

Sponsor
Institute	Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019899