UMIN-CTR Clinical Trial

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
Email	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
Email	nsato@kyotolan.hosp.go.jp

Sponsor
Institute	National Hospital Organization
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027294