UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046052 |
|---|---|
| Receipt number | R000052323 |
| Scientific Title | Determination of plasma levels of growth hormone and related substances before and after exercise using a novel quantification method for anti-doping |
| Date of disclosure of the study information | 2022/02/28 |
| Last modified on | 2021/11/12 13:55:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Determination of plasma levels of growth hormone and related substances before and after exercise using a novel quantification method for anti-doping
Acronym
Determining plasma levels of growth hormone and related substances using a novel quantification method
Scientific Title
Determination of plasma levels of growth hormone and related substances before and after exercise using a novel quantification method for anti-doping
Scientific Title:Acronym
Determining plasma levels of growth hormone and related substances using a novel quantification method
Region
| Japan |
Condition
Condition
Healthy volunteers (Japanese male)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A new analytical method has been developed for quantification of the plasma/serum concentrations of endogenous GH and related substances for anti-doping. The analytical method will be applied to capture the temporal release of GH and related substances after exercise in ordr to verify its ability to capture the time change of the endogenous major and minor variants of GH, and related substances in healthy volunteers.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma/serum concentrations of growth hormone (GH22 and GH20) and related peptide hormones before, and just after and 1h after exercise
Key secondary outcomes
Plasma/serum concentrations of other peptide hormones and cytokines before, and just after and 1h after exercise
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Slightly high intensity exercise, which is considered to be effective in improving overall endurance if continued
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
| Not applicable |
Gender
Male
Key inclusion criteria
Those who have undergone a medical examination and have no restrictions on exercise
Key exclusion criteria
Those who have no restrictions on exercise
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kusuhara |
Organization
The University of Tokyo
Division name
Graduate School of Pharmaceutical Sciences
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL
0358414770
kusuhara@mol.f.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kusuhara |
Organization
The University of Tokyo
Division name
Graduate School of Pharmaceutical Sciences
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL
0358414770
Homepage URL
kusuhara@mol.f.u-tokyo.ac.jp
Sponsor or person
Institute
Graduate School of Arts and Sciences, the University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Anti-Doping Agency
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
DAIICHI SANKYO COMPANY, LIMITED
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Board in the faculty of arts and sciences, the University of Tokyo
Address
3-8-1 Komaba, Meguro-ku, Tokyo, 153-8902, Japan
Tel
03-5454-6014 (Ex 47617)
ken9.c@gs.mail.u-tokyo.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
| 2022 | Year | 02 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 12 | Day |
Last modified on
| 2021 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052323
