UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between visceral fat accumulation and humoral factors in Japanese subjects.
Acronym	Victor-J
Scientific Title	The relationship between visceral fat accumulation and humoral factors in Japanese subjects.
Scientific Title:Acronym	Victor-J
Region	Japan

Condition
Condition	The subjects who have medical health checkup and patients who have or suspected to have cardiovascular disease.
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the relationship between visceral fat accumulation and various humoral factors such as adipocytekines, natriuretic petides and oxidative stress markers.
Basic objectives2	Others
Basic objectives -Others	observation study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visceral fat, humoral factors such as adipocytekines, natriuretic petides and oxidative stress markers.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The subjects who have medical health checkup and patients who have or are suspected to have cardiovascular disease.
Key exclusion criteria	not suitable for this study (doctor desises)
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Iichiro Shimomura, Tohru Funahashi
Organization	Osaka university
Division name	Metabolic Medicine
Zip code
Address	2-2-B5, Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Osaka university
Division name	Metabolic Medicine
Zip code
Address	2-2-B5, Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Osaka university
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Osaka university
Organization
Division
Category of Funding Organization	Self funding
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	2011 Year 12 Month 01 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	Open public recruiting
Date of protocol fixation	2010 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We investigate the relationship between visceral fat accumulation and various humoral parameters such as adipocytekines, natriuretic peptides and oxidative stress markers.

Management information
Registered date	2010 Year 10 Month 04 Day
Last modified on	2011 Year 12 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005173

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