UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013531 |
|---|---|
| Receipt number | R000015813 |
| Scientific Title | Generation of normal ranges to analyze body composition of Japanese adults based on Bioelectrical Impedance Analysis (BIA) |
| Date of disclosure of the study information | 2014/03/27 |
| Last modified on | 2015/03/31 19:08:55 |
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Basic information
Public title
Generation of normal ranges to analyze body composition of Japanese adults based on Bioelectrical Impedance Analysis (BIA)
Acronym
Analysis of body composition of Japanese adults based on BIA
Scientific Title
Generation of normal ranges to analyze body composition of Japanese adults based on Bioelectrical Impedance Analysis (BIA)
Scientific Title:Acronym
Analysis of body composition of Japanese adults based on BIA
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Generate normal ranges for Body Composition based on Bio Impedance Analysis (BIA) of a healthy Japanese population.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The impedance of the body segments, Fat Mass (FM), Fat Free Mass (FFM), Total Body Water (TBW), Extra Cellular Water (ECW), Intra Cellular Water (ICW), Skeletal Muscle Mass (SMM)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
seca medical body composition analyzer
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese healthy adults with a minimum age of 18
Key exclusion criteria
a) chronic diseases that impact fluid homeostasis (e.g. hypertension, heart or kidney failure, patients treated with diuretics)
b) amputation of limbs
c) electrical implant as cardiac pacemaker
d) insulin pumps
e) artificial joints
f) metallic implants (except tooth implants)
g) pregnancy or breastfeeding period
h) probands who cannot provide an ICF by themselves
i) probands who might be dependent from the sponsor or the investigation site
j) probands who cannot wear off jewels including piercings
Target sample size
1016
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Moritoyo |
Organization
The University of Tokyo Hospital
Division name
Phase 1, Unit Clinical Research Support Center
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN
TEL
03-5800-9514
moritoyo-tky@umin.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Moritoyo |
Organization
The University of Tokyo Hospital
Division name
Phase 1, Unit Clinical Research Support Center
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN
TEL
03-5800-9514
Homepage URL
moritoyo-tky@umin.org
Sponsor or person
Institute
The University of Tokyo Hospital
Phase 1, Unit Clinical Research Support Center
Institute
Department
Personal name
Funding Source
Organization
seca gmbh & co. kg
Organization
Division
Category of Funding Organization
Profit organization
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 | 03 | Month | 27 | 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 | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 27 | Day |
Last modified on
| 2015 | 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=R000015813
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
