UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037814 |
|---|---|
| Receipt number | R000043076 |
| Scientific Title | Study on the relationship between skeletal muscle component and glucose metabolism using PET/MR scanner |
| Date of disclosure of the study information | 2019/08/27 |
| Last modified on | 2023/03/03 20:07:10 |
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Basic information
Public title
Muscle research using PET/MR scanner
Acronym
PET/MR research on muscle
Scientific Title
Study on the relationship between skeletal muscle component and glucose metabolism using PET/MR scanner
Scientific Title:Acronym
PET/MR research on skeletal muscle
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose of this study is to measure the energy consumption (glucose metabolism) and metabolite concentrations of skeletal muscles and brain, using a PET/MR scanner.
Basic objectives2
Others
Basic objectives -Others
PET/MR scanner is a unified system of positron emission tomography (PET) and magnetic resonance imaging (MRI) scanners.
In this study, measurements are done in both resting state and exercise load conditions.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
*Standardized Uptake Value and SUV change measured by FDG-PET in brain and muscles.
*Metabolite concentration and its change measured by MRS in brain and muscles.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Injection of 18F-fluorodeoxyglucose (FDG)
Interventions/Control_2
to give exercise load (and resting)
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1) healthy adult men
2) Performance Status (grade0)
3)
3-a) 20 to 40 years old with exercise habits
3-b) 20 to 40 years old without exercise habits
3-c) 65 to 80 years old with exercise habits
3-d) 65 to 80 years old without exercise habits
4) right handed
Key exclusion criteria
1) Person who has abnormality in his brain strctural images
2) Person who has contra-indications to MR examinations
3) Person who has allergies to drugs and foods, etc. (including hypersensitivity to alcohol)
4) Person who has once become ill following injection and infusion.
5) Person who has had experiences of serving as a research volunteer of certain clinical studies in which radiation exposures are given to the subjects (such as other PET studies).
6) Person without minimal exercise ability (to be tested before enrollment)
7) Person with regular medication
8) Person who is diabetic.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | TASHIRO |
Organization
Tohoku Univeristy
Division name
Cyclotron and Radioisotope Center
Zip code
980-8578
Address
6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Myagi-ken 980-8578 Japan
TEL
022-795-7800
manabu.tashiro.a2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | TASHIRO |
Organization
Tohoku University
Division name
Cyclotron and Radioisotope Center
Zip code
980-8578
Address
6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Myagi-ken 980-8578 Japan
TEL
022-795-7797
Homepage URL
driving@cyric.tohoku.ac.jp
Sponsor or person
Institute
Tohoku Univeristy
Cyclotron and Radioisotope Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fukushima Prefectural Medical University
Name of secondary funder(s)
Fukushima Prefectural Medical University
IRB Contact (For public release)
Organization
Ethics Comittee Tohoku University Hospital
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Japan
Tel
022-728-4105
ec@rinri.hosp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Ethics Committee, Tohoku University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東北大学サイクロトロン・RIセンター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 27 | Day |
Last modified on
| 2023 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043076
