UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020564
Receipt number R000023740
Scientific Title The relationship between the risk of metabolic syndrome and body composition in heavyweight athletes
Date of disclosure of the study information 2016/01/14
Last modified on 2016/01/14 12:37:29

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Basic information

Public title

The relationship between the risk of metabolic syndrome and body composition in heavyweight athletes

Acronym

The relationship between physical characteristics and cardiometabolic risk in heavyweight athletes

Scientific Title

The relationship between the risk of metabolic syndrome and body composition in heavyweight athletes

Scientific Title:Acronym

The relationship between physical characteristics and cardiometabolic risk in heavyweight athletes

Region

Japan


Condition

Condition

Cardiometabolic disease, Metabolic syndrome

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to clarify the characteristics of body composition and cardiometabolic risk in heavyweight athletes.

Basic objectives2

Others

Basic objectives -Others

Cross-sectional study

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Blood biochemical parameter

Key secondary outcomes

Parameters related to body composition including cross-sectional area of abdominal fat and muscle and percent body fat


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

18 years-old <=

Age-upper limit

30 years-old >

Gender

Male and Female

Key inclusion criteria

.Heavyweight athletes without
disease under treatment
.The person with usual training status and maintaining usual condition involving body weight and body fat percentage etc. before participating this research

Key exclusion criteria

The person without usualy training by injury and defect
.The person with an electrical magnetic or mechanically operated device in/on their body (i.e. cardiac pacemakers, bone growth stimulation device and cochlear implants hearing aids)
.The person with an intracranial aneurysm clips that operator cannot identify a non-magnetic apparatus
.The person without participating other study

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Motoko Taguchi

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code


Address

2-579-15, Mikajima, Tokorozawa-shi, Saitama, Japan

TEL

04-2947-6778

Email

mtaguchi@waseda.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroko Murata

Organization

Waseda University

Division name

Graduate school of Sport Sciences

Zip code


Address

2-579-15, Mikajima, Tokorozawa-shi, Saitama, Japan

TEL

04-2947-6778

Homepage URL


Email

hiromura@toki.waseda.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

Waseda 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

早稲田大学所沢キャンパス(Waseda University Tokorozawa campus)


Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 14 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2013 Year 09 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study Design/Cross-sectional and observational study

Recruiting/
Recruiting from heavyweight Judo and other sports athletes


Management information

Registered date

2016 Year 01 Month 14 Day

Last modified on

2016 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023740


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name