UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035901 |
|---|---|
| Receipt number | 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 | 2020/02/18 09:43:38 |
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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 | 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
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
tani.shigemasa@nihon-u.ac.jp
Sponsor or person
Institute
Department of Health Planning Center, Nihon University Hospital, Tokyo Japan
Institute
Department
Personal name
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
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
Value
https://center6.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 |
