UMIN-CTR Clinical Trial

Basic information
Public title	The association between visceral fat accumulation and organ damage
Acronym	The association between visceral fat accumulation and organ damage
Scientific Title	The association between visceral fat accumulation and organ damage
Scientific Title:Acronym	The association between visceral fat accumulation and organ damage
Region	Japan

Condition
Condition	Obesity
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the association between visceral fat accumulation and organ damage
Basic objectives2	Others
Basic objectives -Others	To investigate the association of visceral fat accumulation with incident cardiovascular disease, malignant disease, and bone fructure
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cardiovascular event
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	Not applicable
Gender	Male and Female
Key inclusion criteria	people with body mass index equal to or greater than 18.5 kg/m2
Key exclusion criteria	people with active infectious disease or malignant disease pregnant women people with dementia or loss of consciousness people with body mass index less than 18.5 kg/m2
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ryotaro Bouchi
Organization	Tokyo Medical and Dental University
Division name	Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
Zip code
Address	1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL	03-3813-6111
Email	bouchi.mem@tmd.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ryotaro Bouchi
Organization	Tokyo Medical and Dental University
Division name	Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
Zip code
Address	1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL	03-3813-6111
Homepage URL
Email	bouchi.mem@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
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

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 24 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	Completed
Date of protocol fixation	2014 Year 12 Month 16 Day
Date of IRB	2014 Year 12 Month 16 Day
Anticipated trial start date	2014 Year 12 Month 24 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Viscreal fat area is measured by a dual impedance analyzer and the association between visceral fat area and incident cardiovascular disease, malignant disease and bone fructure.

Management information
Registered date	2014 Year 12 Month 23 Day
Last modified on	2022 Year 01 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018642