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

Email

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


Email

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


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 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
Registered date File name

Research case data
Registered date File name