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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035860
Receipt No. R000040578
Scientific Title Study on effect of obesity surgery by quantitative methylation assay of obesity-related gene
Date of disclosure of the study information 2019/02/14
Last modified on 2019/02/12

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Basic information
Public title Study on effect of obesity surgery by quantitative methylation assay of obesity-related gene
Acronym Study on effect of obesity surgery by quantitative methylation assay of obesity-related gene
Scientific Title Study on effect of obesity surgery by quantitative methylation assay of obesity-related gene
Scientific Title:Acronym Study on effect of obesity surgery by quantitative methylation assay of obesity-related gene
Region
Japan

Condition
Condition Obesity
Classification by specialty
Endocrinology and Metabolism Gastrointestinal surgery
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 In recent years, the effectiveness of obesity surgery on patients with high obesity has attracted worldwide attention not only as a weight loss surgery but also as a metabolic improvement surgery including diabetes.There are many unclear points in details of the weight loss effect of obesity surgery.In addition, there are individual differences in the intervention effect of surgery. The reason why weight reduction effect differs among individuals is unknown.Three factors are considered for the onset and progression of obesity: an obesity-related gene which is an inherent property of the individual itself, epigenetics which influences the expression pattern of the postnatal environmental factor later, and lifestyle such as momentum I will.It is considered that its role in actual obesity formation and therapeutic effect is not important to the obesity related gene itself.Rather, it is thought that epigenetics, ie, gene expression regulatory mechanism by DNA methylation, is greatly involved in actual obesity formation and therapeutic effects.In this research, we will examine the following discussion hypothesis.The effect of weight loss by obesity surgery in the treatment of obesity is due to the change in phenotype of obesity-related genes by epigenetics (DNA methylation).Specifically, we will examine the quantitative change of obesity-related gene methylation by obesity surgery for the outpatient with obesity as a primary endpoint.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Quantitative evaluation of obesity-related gene methylation before obesity surgery operation and 6 months after surgery in obese patients
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients whose age ranges from 20 years to under 65 when acquiring consent
2)Patients satisfying the adaptation condition of obesity surgery at the time of acquiring consent
3)After receiving sufficient explanation for participation in this study, patients who sufficiently understand and obtained document consent by their own voluntary intention
Key exclusion criteria 1)Patients complicated of serious heart failure / arrhythmia
2)Patients with severe and under-treated underlying diseases
3)patients with secondary obesity due to endocrinology, drugs, etc.
4)Patients who are inappropriate for obesity surgery due to underlying diseases
5)Those who have judged that the research director and the research assignee are inappropriate as the research subject
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiojima Ichiro
Organization Kansai Medical University
Division name Department of medicine II
Zip code
Address 2-2-2 Shin-machi,Hirakata City,Osaka 573-1191 Japan
TEL 072-804-0101
Email kmuinfo@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhisa Takahashi
Organization Kansai Medical University
Division name Department of medicine II
Zip code
Address 2-2-2 Shin-machi, Hirakata City, Osaka 573-1191 Japan
TEL 072-804-0101
Homepage URL
Email kazuhisa.takahahi.kmu@gmail.com

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization none
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
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 関西医科大学付属病院

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 14 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Target
Kansai Medical University Attached Hospital Health Science Center During obesity outpatient visit, 50 patients undergoing obesity surgery at this hospital are included.
Method and duration of study
(1) Research Period: After approval of the Medical Ethics Committee - March 31, 2021 (Registration end date: September 31, 2020)
(2) Research type / design
Cohort study

Management information
Registered date
2019 Year 02 Month 12 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040578

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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