UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023740 |
|---|---|
| Receipt number | R000027294 |
| Scientific Title | Exploratory research into genetic predisposition for the obesity onset, obesity treatment efficacy, and resistance to obesity treatment in Japanese subjects: establishment of a tailor-made medical treatment |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2020/04/21 17:15:11 |
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Basic information
Public title
Exploratory research into genetic predisposition for the obesity onset, obesity treatment efficacy, and resistance to obesity treatment in Japanese subjects: establishment of a tailor-made medical treatment
Acronym
H26-gene-03
Scientific Title
Exploratory research into genetic predisposition for the obesity onset, obesity treatment efficacy, and resistance to obesity treatment in Japanese subjects: establishment of a tailor-made medical treatment
Scientific Title:Acronym
H26-gene-03
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This is an exploratory research into genetic predisposition for the pathogenesis/progression of obesity, obesity treatment efficacy, and resistance to obesity treatment in Japanese subjects, which is conducted by a genome-wide association study (GWAS), using the existing cohort in a National Hospital Organization. In addition, we will establish a novel prospective cohort and examine the characteristics of the genes explored, thereby identifying the genetic predisposition related to the treatment efficacy. On the basis of these findings, we will propose and develop the tailor-made medical treatment for the individual genetic predisposition.
Basic objectives2
Others
Basic objectives -Others
Exploration and identification of related genes
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in body weight
Key secondary outcomes
Factors associated with metabolic syndrome [glycometabolism, lipid metabolism, blood pressure, index of atherosclerosis, adipocytokine, ectopic fat (visceral fat and fatty liver)]
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with obesity.
2) Lower age limit: 20 years old
3) Gender: male and female.
4) Outpatients and/or inpatients seeking treatment for lifestyle diseases in the hospitals of National Hospital Organization.
5) Patients who have provided written informed consent.
Key exclusion criteria
1) Secondary obesity associated with endocrine disorders.
2) Severe liver dysfunction and liver cirrhosis.
3) Severe renal dysfunction (serum creatinine >= 3.0mg/dl).
4) Patients who are pregnant or under preconceptional care.
5) Subjects judged by the investigator/project leader to be ineligible for other reasons.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Satoh-Asahara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Endocrinology, Metabolism, and Hypertension
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
nsato@kyotolan.hosp.go.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Satoh-Asahara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Endocrinology, Metabolism, and Hypertension
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
Homepage URL
nsato@kyotolan.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5050
kenkyu2004@hosp.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
H26-gene-03
Org. issuing International ID_1
National Hospital Organization
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都医療センター（京都）、函館病院（北海道）、仙台医療センター（宮城県）、宮城病院（宮城県）、渋川医療センター（群馬県）、千葉医療センター（千葉県）、まつもと医療センター松本病院（長野県）、金沢医療センター（石川県）、神戸医療センター（兵庫県）、姫路医療センター（兵庫県）、福山医療センター（広島県）、米子医療センター（鳥取県）、南岡山医療センター（岡山県）、長崎病院（長崎県）、都城医療センター（宮崎県）、九州医療センター（福岡県）、鹿児島医療センター（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Main Observation Item:
Whole genome information by GWAS
Management information
Registered date
| 2016 | Year | 08 | Month | 23 | Day |
Last modified on
| 2020 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027294
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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