UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041928
Receipt number 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 2023/11/20 12:46:56

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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 or person

Institute

Faculty of Applied Bioscience, Tokyo University of Agriculture

Institute

Department

Personal name



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

No longer recruiting

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

2023 Year 11 Month 20 Day



Link to view the page

Value
https://center6.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