UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035860 |
|---|---|
| Receipt number | 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 21:40:02 |
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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
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
kazuhisa.takahahi.kmu@gmail.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040578
