UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013911 |
|---|---|
| Receipt number | R000016217 |
| Scientific Title | Effect of exercise on fatty liver and skeletal muscle in obese - using MRI and ultrasound- |
| Date of disclosure of the study information | 2014/05/09 |
| Last modified on | 2021/05/13 15:06:28 |
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Basic information
Public title
Effect of exercise on fatty liver and skeletal muscle in obese - using MRI and ultrasound-
Acronym
Effect of exercise on fatty liver and skeletal muscle
Scientific Title
Effect of exercise on fatty liver and skeletal muscle in obese - using MRI and ultrasound-
Scientific Title:Acronym
Effect of exercise on fatty liver and skeletal muscle
Region
| Japan |
Condition
Condition
Obese
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the changes in pathology arrangement of skeletal muscle and liver by exercise of obese individuals using ultrasound and MRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MR Spectroscopy
Fibroscan (Liver)
Visceral adipose tissue (MRI)
Key secondary outcomes
Body composition
Energy intake
Energy expenditure
Blood chemistry data
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Aerobic exercise
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1.Aged 30 to 60 years
2.BMI of greater than 25
3.Who is not prohibited the exercise from doctor
4.Who does not have regular exercise habit
5.To participate based on the local newspaper (Ibaraki local community publication Joyo living)
Key exclusion criteria
1.Before the physical fitness test and blood sampling, we conducted interviews past history health, arthritis, heart disease. Also it is not performed when it is determined to be dangerous by Junichi Shoda (doctor).
2.Who of drug or alcohol addiction
3.(Including blood donation)blood collection of more than 400 ml within 12 weeks or 200 ml, within 4 weeks before the start of the study.
4. Who have practiced
5.Who has participated in other clinical trials within four months before the start of the study.
6.Who has been installed and electronic devices, including the ferromagnetic body.
7.Who claustrophobic.
8.Who can not be with the consent of the study participants than himself.
9.Who is not judged not eligible by Junichi Shoda (doctor) and Okamoto Kiichi (doctor)
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Okamoto |
Organization
University of Tsukuba Hospital
Division name
Diagnostic radiology
Zip code
3058576
Address
Ibarakiken Tsukuba city Amakubo 2-1-1
TEL
029-853-3205
yokamoto@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Okamoto |
Organization
University of Tsukuba Hospital
Division name
Diagnostic radiology
Zip code
3058576
Address
Ibarakiken Tsukuba city Amakubo 2-1-1
TEL
029-853-3205
Homepage URL
yokamoto@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
Ibarakiken Tsukuba city Amakubo 2-1-1
Tel
029-853-3914
toyoshima.yuka.gn@un.tsukuba.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
| 2014 | Year | 05 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2017 | 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
| 2014 | Year | 05 | Month | 08 | Day |
Last modified on
| 2021 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016217
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
