UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056099 |
|---|---|
| Receipt number | R000064073 |
| Scientific Title | A Study of the Relationship between Blood Pressure and Prognosis and Estimated Salt Intake Calculated from Urinary Sodium Concentration at Any Time |
| Date of disclosure of the study information | 2024/11/08 |
| Last modified on | 2024/11/08 12:25:12 |
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Basic information
Public title
A Study of the Relationship between Blood Pressure and Prognosis and Estimated Salt Intake Calculated from Urinary Sodium Concentration at Any Time
Acronym
A Study of the Relationship between Blood Pressure and Prognosis and Estimated Salt Intake Calculated from Urinary Sodium Concentration at Any Time
Scientific Title
A Study of the Relationship between Blood Pressure and Prognosis and Estimated Salt Intake Calculated from Urinary Sodium Concentration at Any Time
Scientific Title:Acronym
A Study of the Relationship between Blood Pressure and Prognosis and Estimated Salt Intake Calculated from Urinary Sodium Concentration at Any Time
Region
| Japan |
Condition
Condition
atherosclerosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Data on changes in the hypertensive population, the number of cerebrovascular events, and medical costs as a result of Kure City's salt reduction activities will be analyzed. In addition, by evaluating the relationship between blood pressure and salt intake, exercise, body weight, lipids, blood glucose, etc. in subjects undergoing specific health check-ups, we aim to 1) clarify the relationship between salt intake, diet, exercise, body weight, etc. that define optimal blood pressure, and 2) clarify the relationship between blood pressure, salt intake, and the incidence of cardiovascular disease events.
Basic objectives2
Others
Basic objectives -Others
we aim to 2) clarify the relationship between blood pressure, salt intake, and the incidence of cardiovascular disease events.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trends in blood pressure levels, incidence of hypertension and cerebrovascular disease or cardiovascular disease, and medical costs
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults who underwent a specific health checkup conducted in Kure City, Hiroshima Prefecture, during the selected period.
Key exclusion criteria
Are considered not eligible for the study by the attending doctor due to other reasons
Target sample size
99222
Research contact person
Name of lead principal investigator
| 1st name | Yukihito |
| Middle name | |
| Last name | Higashi |
Organization
Hiroshima University
Division name
Department of Regenerative Medicine, Division of Radiation Medical Science, Research Institute for Radiation Biology and Medicine,
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082(257)5831
yhigashi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Kishimoto |
Organization
Hiroshima University
Division name
Department of Regenerative Medicine, Division of Radiation Medical Science, Research Institute for R
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082(257)5831
Homepage URL
skishimoto@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
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
the ethical committees of Hiroshima University
Address
1-2-3 Kasumi, Minamiku, Hiroshima
Tel
082-257-1752
iryo-sinsa@office.hiroshima-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
| 2024 | Year | 11 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The data to be used in the study are sex, age at the time of medical checkup, date of medical checkup, height, weight, abdominal circumference, BMI, systolic blood pressure, diastolic blood pressure, triglycerides, fasting, triglycerides, HDL cholesterol, LDL cholesterol, GOT, GPT, gamma-GT (gamma-GTP), fasting blood glucose, anytime blood glucose, HbA1c (NGSP), creatinine, e-GFR (calculated value), uric acid, urinary glucose, urinary protein HbA1c (NGSP), creatinine, e-GFR (reported value), e-GFR (calculated value), uric acid, uric sugar, urinary protein, urinary occult blood, urinary sodium, urinary creatinine, estimated salt intake, hematocrit value, blood pigment content, red blood cell count, anemia test, judgment result A, judgment result B, detailed physical examination results, medications (blood pressure), medications (blood pressure), blood pressure, blood pressure, blood pressure, blood pressure, blood pressure, blood pressure (blood pressure), medication (blood sugar), medication (lipid), medical history (cerebrovascular), medical history (cardiovascular), medical history (renal failure, dialysis), smoking (from medical interview), medical history), and the incidence of hypertension and cerebrovascular diseases and medical expenses on the national health insurance receipts for each year.
Management information
Registered date
| 2024 | Year | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064073
