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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032823
Receipt No. R000037326
Scientific Title Cross-sectional association between the rate of persons particapating in specific health checkups and the rate of persons either demonstrating metabolic syndrome or pre-metabolic syndrome, and the number of patients with prevalent and incident chronic dialysis per unit population according to the causes of chronic kidney disease
Date of disclosure of the study information 2018/06/03
Last modified on 2019/02/03

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Basic information
Public title Cross-sectional association between the rate of persons particapating in specific health checkups and the rate of persons either demonstrating metabolic syndrome or pre-metabolic syndrome, and the number of patients with prevalent and incident chronic dialysis per unit population according to the causes of chronic kidney disease
Acronym Cross-sectional association between the rate of persons particapating in specific health checkups and the rate of persons with metabolic syndrome, and the number of patients with chronic dialysis per unit population according to the causes of chronic kidney disease
Scientific Title Cross-sectional association between the rate of persons particapating in specific health checkups and the rate of persons either demonstrating metabolic syndrome or pre-metabolic syndrome, and the number of patients with prevalent and incident chronic dialysis per unit population according to the causes of chronic kidney disease
Scientific Title:Acronym Cross-sectional association between the rate of persons particapating in specific health checkups and the rate of persons with metabolic syndrome, and the number of patients with chronic dialysis per unit population according to the causes of chronic kidney disease
Region
Japan

Condition
Condition chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to clarify the cross-sectional association between the rate of persons partipating in specific health checkups and the rate of persons either demonstrating metabolic syndrome or pre-metabolic syndrome, and the number of patients with prevalent and incident chronic dialysis per unit population of each prefecture according to the causes of chronic kidney disease.
Basic objectives2 Others
Basic objectives -Others The second objective of this study is to clarify the annual change of the cross-sectional association between the rate of persons participating in specific health checkups and the rate of persons either demonstrating metabolic syndrome and pre-metabolic syndrome, and the number of patients with prevalent and incident chronic dialysis per unit population of each prefecture according to the causes of chronic kidney disease.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Cross-sectional association between the rate of persons partipating in specific health checkups and the rate of persons either demonstrating metabolic syndrome or pre-metabolic syndrome, and the number of patients with prevalent and incident chronic dialysis per unit population of each prefecture according to the causes of chronic kidney disease
Key secondary outcomes Annual change of the cross-sectional association between the rate of persons partipating in specific health checkups and the rate of persons either demonstrating metabolic syndrome or pre-metabolic syndrome, and the number of patients with prevalent and incident chronic dialysis per unit population of each prefecture according to the causes of chronic kidney disease

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Japanese
The adult participating in specific health checkups
Key exclusion criteria none
Target sample size 47

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Ogi
Organization Yuurinkouseikai Fuji Hospital
Division name Department of Internal Medicine
Zip code
Address 1784 Niihashi Gotemba Shizuoka
TEL 0550-83-3333
Email ogi@yuurinkouseikai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ogi
Organization Yuurinkouseikai Fuji Hospital
Division name Department of Internal Medicine
Zip code
Address 1784 Niihashi Gotemba Shizuoka
TEL 0550-83-3333
Homepage URL
Email ogi@yuurinkouseikai.or.jp

Sponsor
Institute Yuurinkouseikai Fuji Hospital
Institute
Department

Funding Source
Organization Yuurinkouseikai Fuji Hospital
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 06 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The rate of persons participating in specific health checkups showed a negative correlation with the number of patients with prevalent (r0.39 p0.007) or incident (r0.46 p0.003) chronic dialysis per unit population in 2015. When comparing the patients according to the categories of primary diseases, the participation rate in specific health checkups had a significantly negative correlation with the number of prevalent and incident dialysis patients with diabetic nephropathy, prevalent and incident dialysis patients with chronic nephritis, and incident dialysis patients with nephrosclerosis per unit population for each prefecture. The rate of persons with metabolic syndrome or the pre-metabolic syndrome had a positive correlation with the total number of prevalent chronic dialysis patients (r0.42 p0.004) and prevalent (r0.44 p0.002) and incident (r0.39 p0.007) dialysis patients with diabetic nephropathy per unit population for each prefecture. The number of prevalent dialysis patients with diabetic nephropathy and the rate of persons with metabolic syndrome or the pre-metabolic syndrome were found to correlate with each other based on a multiple regression analysis, with the number of incident dialysis patients with diabetic nephropathy independently correlated with the participation rate in specific health checkups and the rate of persons with metabolic syndrome or pre-metabolic syndrome. 
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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The specific health checkups may restrain not only cardiovascular disease but also the onset and progression of diabetes mellitus and chronic kidney disease by decreasing the rate of persons with metabolic syndrome.Clarifying the cross-sectional association between the rate of persons participating in specific health checkups and the rate of persons either demonstrating metabolic syndrome or pre-metabolic syndrome, and the number of patients with prevalent and incident chronic dialysis per unit population according to causes of chronic kidney disease may provide useful informations for reducing number of patients with end stage kidney disease.

Management information
Registered date
2018 Year 06 Month 01 Day
Last modified on
2019 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037326

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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