UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032823 |
|---|---|
| Receipt number | 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 | 2024/11/24 11:44:10 |
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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 | Makoto |
| Middle name | |
| Last name | Ogi |
Organization
Yuurinkouseikai Fuji Hospital
Division name
Department of Internal Medicine
Zip code
412-0043
Address
1784 Niihashi Gotemba Shizuoka
TEL
0550-83-3333
ogi@yuurinkouseikai.or.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ogi |
Organization
Yuurinkouseikai Fuji Hospital
Division name
Department of Internal Medicine
Zip code
412-0043
Address
1784 Niihashi Gotemba Shizuoka
TEL
0550-83-3333
Homepage URL
ogi@yuurinkouseikai.or.jp
Sponsor or person
Institute
Yuurinkouseikai Fuji Hospital
Institute
Department
Personal name
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
Yuurinkouseikai Fuji Hospital
Address
1784 Niihashi Gotemba Shizuoka
Tel
0550-83-3333
clerk@yuurinkouseikai.or.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
| 2018 | Year | 06 | Month | 03 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
47
Results
The rate of persons participating in specific health checkups (PR) showed a negative correlation with the number of incident dialysis patients per unit population (NID) due to total diseases (r0.46 p0.003), diabetic nephropathy (DN), chronic nephritis, and nephrosclerosis in 2015. The rate of metabolic or pre-metabolic syndrome (RMS) had a positive correlation with NID due to DN (r0.39 p0.007). A multiple regression analysis showed that PR and RMS independently correlated with NID due to DN.
Results date posted
| 2024 | Year | 11 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
2015
The median rate of persons participating in specific health chechup(IQR) 0.487(0.458-0.525)
The median rate of persons with pre-matabolic syndrome(IQR) 0.117(0.113-0.122)
The median rate of persons with metabolic syndrome(IQR) 0.146(0.139-0.156)
The median number of incident dialysis patients according to all causes per 100000 population(IQR) 29.917(27.425-35.009)
The median number of incident dialysis patients according to diabetic nephropathy per 100000 population(IQR) 13.337(11.720-14.573)
Participant flow
47 prefectures
Adverse events
None
Outcome measures
The rate of persons participating in specific health chechup
The rate of persons with pre-matabolic and metabolic syndrome
The number of incident dialysis patients per unit population
according to the primary disease
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
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
| 2024 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037326
