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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028496
Receipt No. R000032459
Scientific Title Investigation by quantitative evaluation of DNA methylation by resistance training at treatment of obesity
Date of disclosure of the study information 2017/08/03
Last modified on 2018/09/10

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Basic information
Public title Investigation by quantitative evaluation of DNA methylation by resistance training at treatment of obesity
Acronym Epigenetics study of obesity-related genes
Scientific Title Investigation by quantitative evaluation of DNA methylation by resistance training at treatment of obesity
Scientific Title:Acronym 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
1st name
Middle name
Last name Yutaka Kimura
Organization Kansai Medical University Hospital
Division name Health science
Zip code
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
1st name
Middle name
Last name Haruhiko Nishida
Organization Kansai Medical University Hospital
Division name Health science
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2016 Year 12 Month 20 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000032459

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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