UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048882 |
|---|---|
| Receipt number | R000055461 |
| Scientific Title | Diagnostic performance of ABSI (A body shape index) for visceral adiposity in Japanese adults. |
| Date of disclosure of the study information | 2022/09/08 |
| Last modified on | 2023/03/31 14:05:36 |
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Basic information
Public title
Diagnostic performance of ABSI (A body shape index) for visceral adiposity in Japanese adults.
Acronym
Diagnostic performance of ABSI (A body shape index) for visceral adiposity.
Scientific Title
Diagnostic performance of ABSI (A body shape index) for visceral adiposity in Japanese adults.
Scientific Title:Acronym
Diagnostic performance of ABSI (A body shape index) for visceral adiposity.
Region
| Japan |
Condition
Condition
General Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the cut-off point at which visceral adiposity can be determined for ABSI and to examine its diagnostic performance.
Basic objectives2
Others
Basic objectives -Others
To determine the cut-off point at which visceral adiposity can be determined for ABSI and to examine its diagnostic performance.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine the cut-off point at which visceral adiposity can be determined for ABSI and to examine its diagnostic performance.
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
1.Subjects who have consented to participate in research conducted by our department from FY 2017 to FY 2021 and have also consented to use the information for other purposes (secondary use of information).
2.Subjects whose height, weight, and abdominal circumference were measured in the study in which they participated.
3.Subjects who had visceral fat area measured by abdominal bioimpedance method in the participating study.
Key exclusion criteria
1.Subjects who have requested to withdraw from participation in this study.
2.Subjects who are judged as unsuitable for this study by the principal investigator.
Target sample size
333
Research contact person
Name of lead principal investigator
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Department of Food & Health Research, Clinical research support center, University of Miyazaki hospital
Zip code
889-1692
Address
Kihara5200,Kiyotake,Miyazaki889-1692,Japan
TEL
0985-85-9577
yasuji_arimura@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Dept. of Food & Health Research, Clinical research support center, University of Miyazaki hospital
Zip code
889-1692
Address
Kihara5200,Kiyotake,Miyazaki889-1692,Japan
TEL
0985-85-9577
Homepage URL
yasuji_arimura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
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
Research Ethics Committee of University of Miyazaki
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-u.ac.jp
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
| 2022 | Year | 09 | Month | 08 | 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
| 2022 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 14 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 26 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 26 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 16 | Day |
Other
Other related information
-Cross-sectional study.
-The subjects will be those who participated in research conducted by the Department of Food & Health Research, Clinical research support center, University of Miyazaki hospital from FY2017 to FY2021, and underwent anthropometric measurements including visceral fat area measurement by abdominal bioimpedance method.
-Information to be collected: Basic information of the subjects (gender, age, names of diseases attended, pre-existing diseases), physical measurements (height, weight, BMI, abdominal circumference), visceral fat area (visceral fat area measured by abdominal bioimpedance method).
Management information
Registered date
| 2022 | Year | 09 | Month | 08 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055461
