UMIN-CTR Clinical Trial

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
Email	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
Email	kusuhara@mol.f.u-tokyo.ac.jp

Sponsor
Institute	Graduate School of Arts and Sciences, the University of Tokyo
Institute
Department

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)
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052323