UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016037 |
|---|---|
| Receipt number | R000018642 |
| Scientific Title | The association between visceral fat accumulation and organ damage |
| Date of disclosure of the study information | 2014/12/24 |
| Last modified on | 2022/01/04 08:34:31 |
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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
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
bouchi.mem@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018642
