UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019015 |
|---|---|
| Receipt number | R000020989 |
| Scientific Title | Association between sympathetic nerve activation by exercise and serum level of fatty acid binding protein 4 |
| Date of disclosure of the study information | 2015/09/28 |
| Last modified on | 2017/10/02 10:13:25 |
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Basic information
Public title
Association between sympathetic nerve activation by exercise and serum level of fatty acid binding protein 4
Acronym
Sympathetic nerve activation and serum FABP4
Scientific Title
Association between sympathetic nerve activation by exercise and serum level of fatty acid binding protein 4
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tatsuya Iso |
Organization
Gunma University Graduate school of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8145
isot@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Iso |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
+81272208145
Homepage URL
isot@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Department of Cardiovascular Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Clinical Biochemistry, 2017.
pii: S0009-9120(17)30426-5.
doi: 10.1016/j.clinbiochem.2017.05.021.
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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 14 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020989
