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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041928
Receipt No. R000047852
Scientific Title Preliminary analysis of aerobic and anaerobic glycolysis using stable isotope
Date of disclosure of the study information 2020/10/01
Last modified on 2020/09/29

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Basic information
Public title Assessment of glucose utilization using stable isotope
Acronym Assessment of glucose utiliztion
Scientific Title Preliminary analysis of aerobic and anaerobic glycolysis using stable isotope
Scientific Title:Acronym Analysis of glycolysis using stable isotope
Region
Japan

Condition
Condition Healthy population
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Preliminary examination of glycolysis during exercise.
Basic objectives2 Others
Basic objectives -Others To examine speed and/or quantity of aerobic and anaerobic glycolysis during rest and exercise, and the effect of training.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Concentration of 13CO2/14CO2 in expired gas during 150 minutes after glucose dosing
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
Food
Interventions/Control_1 Single dose of 1-13C, 2-13C, or 3-13C glucose(100mg), and rest or cycling after dosing
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
30 years-old >
Gender Male and Female
Key inclusion criteria Doctors accepted to join the exercise intervention.
Key exclusion criteria Without the diseases affecting glucose metabolism (diabetes mellitus), and energy metabolism (thyroid diseases)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kazuko
Middle name
Last name Ishikawa-Takata
Organization Tokyo University of Agriculture
Division name Faculty of Applied Bioscience
Zip code 1568502
Address 1-1-1 Sakuragaoka, Setagaya, Tokyo
TEL 03-5477-2453
Email kt207460@nodai.ac.jp

Public contact
Name of contact person
1st name Kazuko
Middle name
Last name Ishikawa-Takata
Organization Tokyo University of Agriculture
Division name Faculty of Applied Bioscience
Zip code 1568502
Address 1-1-1 Sakuragaoka, Setagaya, Tokyo
TEL 03-5477-2453
Homepage URL
Email kt207460@nodai.ac.jp

Sponsor
Institute Faculty of Applied Bioscience, Tokyo University of Agriculture
Institute
Department

Funding Source
Organization Tokyo University of Agriculture
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo University of Agriculture,
Address The ethical committee for Human Study
Tel 03-5477-2532
Email t3tanaka@nodai.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
2020 Year 10 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 Enrolling by invitation
Date of protocol fixation
2020 Year 09 Month 25 Day
Date of IRB
2020 Year 09 Month 25 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 29 Day
Last modified on
2020 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047852

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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