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UMIN-CTR Clinical Trial |
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Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000002997 |
Receipt No. | R000003633 |
Scientific Title | Life-style related desease and cardiovascular disease study |
Date of disclosure of the study information | 2010/07/08 |
Last modified on | 2013/08/09 |
Basic information | |||
Public title | Life-style related desease and cardiovascular disease study | ||
Acronym | The Osaka University Visceral Fat Study
(O-VFStudy) |
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Scientific Title | Life-style related desease and cardiovascular disease study | ||
Scientific Title:Acronym | The Osaka University Visceral Fat Study
(O-VFStudy) |
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Region |
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Condition | ||||
Condition | Life-style related disease | |||
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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Organization | Osaka University | ||||||
Division name | Metabolic medicine | ||||||
Zip code | |||||||
Address | 2-2 B5, Yamada-oka, Suita, Osaka 565-0871, Japan | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | Osaka University | ||||||
Division name | Metabolic medicine | ||||||
Zip code | |||||||
Address | |||||||
TEL | |||||||
Homepage URL | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003633 |