UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation by quantitative evaluation of DNA methylation by resistance training at treatment of obesity
Title of the study (Brief title)	Epigenetics study of obesity-related genes
Region	Japan

Condition
Condition	Obese patient
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Quantitative assessment of the methylation of obesity-related genes before and after resistance movement intervention in outpatients with obesity and verification of effects on body composition, metabolic function and muscle force change rate
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Quantitative evaluation of obesity-related gene methylation by resistance training intervention
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Resistance training intervention for highly obese patients Frequency more than 5 days / week(individual correspondence + home training: 6 months)
Interventions/Control_2	Highly obese patients (no individual correspondence + no home training)
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 and Female
Key inclusion criteria	Consent acquirer After receiving sufficient explanation for participation in this research, those who gained document consent by their own free will with sufficient understanding BMI25more
Key exclusion criteria	Subjects who cannot be measured, subjects of paralysis or rheumatoid arthritis Others who have judged that the research director is inappropriate as the research subject
Target sample size	30

Research contact person
Name of lead principal investigator	Yutaka Kimura
Organization	Kansai Medical University Hospital
Division name	Health science
Address	2-5-1Shin-machi, Hirakata City,Osaka 573-1010Japan
TEL	072-804-0101
Email	drkimura@alles.or.jp

Public contact
Name of contact person	Haruhiko Nishida
Organization	Kansai Medical University Hospital
Division name	Health science
Address	2-5-1Shin-machi, Hirakata City,Osaka 573-1010Japan
TEL	072-804-0101
Homepage URL
Email	nishidah@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 03 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 12 Month 20 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 02 Day
Last modified on	2018 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032459