UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014046 |
|---|---|
| Receipt number | R000016351 |
| Scientific Title | Influence of diet and physical activity on progression of the metabolic domino: community-based and health checkup system-based prospective cohort-study. |
| Date of disclosure of the study information | 2014/05/22 |
| Last modified on | 2023/11/28 21:20:55 |
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Basic information
Public title
Influence of diet and physical activity on progression of the metabolic domino: community-based and health checkup system-based prospective cohort-study.
Acronym
Community health survey in Uonuma-region; Uonuma cohort study
Scientific Title
Influence of diet and physical activity on progression of the metabolic domino: community-based and health checkup system-based prospective cohort-study.
Scientific Title:Acronym
Community health survey in Uonuma-region; Uonuma cohort study
Region
| Japan |
Condition
Condition
Lifestyle-related diseases
Classification by specialty
| Medicine in general | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the impact of diet and physical activity on progression of the metabolic domino, which is the common pathway of lifestyle-related diseases relevant to leading Japanese mortality causes.
Basic objectives2
Others
Basic objectives -Others
To evaluate the predictive factors on cerebrovascular disease, hypertension and chronic kidney disease, which are the specific concerns in Uonuma-region.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Incidence and mortality rate of cerebrovascular disease in Uonuma-region.
2. Detection of risk factors on progression of lifestyle-related diseases, including cerebrovascular disease, hypertension and chronic kidney disease.
Key secondary outcomes
Subsidiary research on environmental and hereditary factors through biomarker and gene analyses.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A. Health and lifestyle-related questionnaire: residents of Minamiuonuma-city, and Uonuma-city.
B. Donation of health checkup data, blood and urine samples: health checkup examinees of Minamiuonuma-city, and Uonuma-city.
Key exclusion criteria
Not applicable.
Target sample size
35000
Research contact person
Name of lead principal investigator
| 1st name | Ichiei |
| Middle name | |
| Last name | Narita |
Organization
Niigata University
Division name
Department of Health Promotion Medicine
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-city, Niigata, Japan.
TEL
0253689009
juntatnk@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Junta |
| Middle name | |
| Last name | Tanaka |
Organization
Niigata university
Division name
Department of Health Promotion Medicine
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-city, Niigata, Japan.
TEL
0253689009
Homepage URL
https://www.facebook.com/NUHPM/
juntatnk@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Junta Tanaka
Funding Source
Organization
Niigata-prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Cancer Center, Research Center for Cancer Prevention and Screening.
The University of Tokyo, Department of Diabetes and Metabolic Diseases.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-city, Niigata, Japan.
Tel
0252272625
sanonao@adm.niigata-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
| 2014 | Year | 05 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.facebook.com/NUHPM/notes
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
5th anniversary survey in progress
Management information
Registered date
| 2014 | Year | 05 | Month | 22 | Day |
Last modified on
| 2023 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016351
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
