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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035901
Receipt No. R000040902
Scientific Title A Cross-sectional Study Examining Association of Serum Uric Acid Level with Abdominal Obesity and Cardio-metabolic Risk in Japan: Assessment of Gender Differences
Date of disclosure of the study information 2019/03/01
Last modified on 2019/03/12

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Basic information
Public title A Cross-sectional Study Examining Association of Serum Uric Acid Level with Abdominal Obesity and Cardio-metabolic Risk in Japan: Assessment of Gender Differences
Acronym Uric acid and abdominal obesity
Scientific Title A Cross-sectional Study Examining Association of Serum Uric Acid Level with Abdominal Obesity and Cardio-metabolic Risk in Japan: Assessment of Gender Differences
Scientific Title:Acronym Uric acid and abdominal obesity
Region
Japan

Condition
Condition apparently healthy subjects with no
history of uric acid lowering therapy
or ASCVD, undergoing medical examinations at the Health Planning Center of Nihon University Hospital
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated the relationship between UA level and cardio-metabolic risk, especially abdominal obesity,based on the Japanese criteria of metabolic syndrome).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The aim of this study was to investigate by gender the relationship between serum UA level and abdominal obesity assessed by waist circumference, using a cross-sectional research method, and to clarify the relationship between serum UA level and cardio-metabolic risk in a Japanese. Population.
Key secondary outcomes

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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria apparently healthy subjects with no history of UA lowering therapy or ASCVD at the Health Planning Center of Nihon
University Hospital
Key exclusion criteria subjects with history of UA lowering therapy and ASCVD
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigemasa Tani
Organization Nihon University Hospital
Division name Health Planning Center
Zip code
Address 1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8309, Japan
TEL 0332931711
Email tani.shigemasa@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigemasa Tani
Organization Nihon University Hospital
Division name Health Planning Center
Zip code
Address 1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8309, Japan
TEL 0332931711
Homepage URL
Email tani.shigemasa@nihon-u.ac.jp

Sponsor
Institute Department of Health Planning Center, Nihon University Hospital, Tokyo Japan
Institute
Department

Funding Source
Organization Department of Health Planning Center, Nihon University Hospital, Tokyo Japan
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

Other administrative information
Date of disclosure of the study information
2019 Year 03 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
2018 Year 12 Month 01 Day
Date of IRB
2017 Year 11 Month 01 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Collecting data in this study

Management information
Registered date
2019 Year 02 Month 17 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040902

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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