UMIN-CTR Clinical Trial

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 Shigemasa Middle name Last name Tani
Organization	Nihon University Hospital
Division name	Health Planning Center
Zip code	101-8309
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 Shigemasa Middle name Last name Tani
Organization	Nihon University Hospital
Division name	Health Planning Center
Zip code	101-8309
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	Nihon University Hospital
Address	1-6 kandasurugadai, chiyodaku, Tokyo 101-8309, Japan
Tel	0332931711
Email	tani.shigemasa@nihon-u.ac.jp

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	Terminated
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	2020 Year 02 Month 18 Day

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