UMIN-CTR Clinical Trial

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
Email	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
Email	yokamoto@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016217