UMIN-CTR Clinical Trial

Basic information
Public title	Life-style related desease and cardiovascular disease study
Acronym	The Osaka University Visceral Fat Study (O-VFStudy)
Scientific Title	Life-style related desease and cardiovascular disease study
Scientific Title:Acronym	The Osaka University Visceral Fat Study (O-VFStudy)
Region	Japan Asia(except Japan)

Condition
Condition	Life-style related 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 life-style disease, adipocytokines, body fat distibution and/or other markers
Basic objectives2	Others
Basic objectives -Others	We aim to establish the prevention for cardiovascular disease based on life-style disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	adipocytokines in life-style related diseases
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	Subjects have the possibility of life-style related disease including diabetes, hyertension, dyslipidemia, cardiobascular disease and/or sleep apnea syndrome in Osaka unversity and joint-research facilities, and the study was approved by the human ethics committee of Osaka University and a written informed consent was obtained from each subject.
Key exclusion criteria	none
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Iichiro Shimomura
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
TEL
Homepage URL
Email	kkishida@imed2.med.osaka-u.ac.jp

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	Kokura Memorial Hospital Kenporen Osaka Central Hospital
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	大阪大学医学部附属病院（大阪府）、小倉記念病院（福岡県）、大阪中央病院（大阪府）、よしだ睡眠呼吸クリニック（大阪府）、大手前病院（大阪府）などの全国研究関連施設

Other administrative information
Date of disclosure of the study information	2010 Year 07 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	2008 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date	2009 Year 04 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	This study consists of prospective study.

Management information
Registered date	2010 Year 01 Month 08 Day
Last modified on	2013 Year 08 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003633

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