UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between sympathetic nerve activation by exercise and serum level of fatty acid binding protein 4
Title of the study (Brief title)	Sympathetic nerve activation and serum FABP4
Region	Japan

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

Objectives
Narrative objectives1	To study whether sympathetic nerve activation by exercise increase serum level of FABP4
Basic objectives2	Others
Basic objectives -Others	To study whether sympathetic nerve activation by strong exercise over anaerobic threshold increase serum level of FABP4
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	an increase in serum level of FABP4 by exercise
Key secondary outcomes	an increase in plasma level of catecholamine by exercise

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	Device,equipment
Interventions/Control_1	Exercise by ergometer will be performed three times. 1st exercise: to study relation between loading strength and heart rate. 2nd exercise: to carry out strong load for 5 to 10 min, target heart rate 150 bpm 3rd exercise: to carry out weak load for 5 to 10 min, target heart rate 100 bpm Interval between exercises is more than a week. From September 28, 2015 to March 31, 2017
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	35 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy
Key exclusion criteria	No disease under treatment No severe past history
Target sample size	40

Research contact person
Name of lead principal investigator	Tatsuya Iso
Organization	Gunma University Graduate school of Medicine
Division name	Department of Cardiovascular Medicine
Address	3-39-15 Showa-machi, Maebashi, Gunma
TEL	027-220-8145
Email	isot@gunma-u.ac.jp

Public contact
Name of contact person	Tatsuya Iso
Organization	Gunma University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	3-39-15 Showa-machi, Maebashi, Gunma
TEL	+81272208145
Homepage URL
Email	isot@gunma-u.ac.jp

Sponsor
Institute	Gunma University Graduate School of Medicine Department of Cardiovascular Medicine
Institute
Department

Funding Source
Organization	Gunma University Graduate School of Medicine Department of Cardiovascular Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	群馬大学大学院（循環器内科）

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 14 Day
Anticipated trial start date	2015 Year 09 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Clinical Biochemistry, 2017. pii: S0009-9120(17)30426-5. doi: 10.1016/j.clinbiochem.2017.05.021.
Other related information

Management information
Registered date	2015 Year 09 Month 14 Day
Last modified on	2017 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020989