UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038610 |
|---|---|
| Receipt number | R000043957 |
| Scientific Title | Identification of correlates of noturnal polyuria, with special attention to metabolomics |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2022/09/15 16:18:09 |
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Basic information
Public title
Identification of correlates of noturnal polyuria, with special attention to metabolomics
Acronym
Metabolomics approach for nocturnal polyuria
Scientific Title
Identification of correlates of noturnal polyuria, with special attention to metabolomics
Scientific Title:Acronym
Metabolomics approach for nocturnal polyuria
Region
| Japan |
Condition
Condition
nocturnal polyuria
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify metabolites in blood and urine, correlating to nocturnal polyuria, by comparing diurnal with nocturnal metabolites in patients, and by comparing those of patients with general population
Basic objectives2
Others
Basic objectives -Others
To identify metablites in blood and urine, correlating to nocturnal polyuria, by comparing those in patients with nocturnal polyuria and those in controls, who have no nocturia.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of metabolites correlating to nocturnal polyuria
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) ECOG performance status: 0~1
2) Pts., who can perform 3-day frequency-volume charts
Key exclusion criteria
1) Pts., the contents of whose peroral medicine change within 4 weeks.
2) Pts., who undergo surgical intervention within 4 weeks.
3) Pts., who perorally receive diuretics or anti-diuretics, such as vasopression or its analogue.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Yoshimura |
Organization
Shizuoka General Hospital
Division name
urology
Zip code
420-8527
Address
4-27-1, Kitaando, Aoi-ku, Shizuoka
TEL
0542476111
ky7527@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Yoshimura |
Organization
Shizuoka General Hospital
Division name
urology
Zip code
420-8527
Address
4-27-1, Kitaando, Aoi-ku, Shizuoka
TEL
0542476111
Homepage URL
ky7527@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee of Shizuoka General Hospital
Address
4-27-1, Kitaando, Aoi-ku, Shizuoka
Tel
0542476111
chiken-sougou@shizuoka-pho.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 | 12 | 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
45
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
| 2019 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Frequency volume charts, nocturnal and early morning motabolomics analyses using blood and urine samples, questionnaire for LUTS, measurement of renal blood flow, ABI, PMV, RR interval, examination of respiratory function, measurement of moisture quantity in the body
Management information
Registered date
| 2019 | Year | 11 | Month | 18 | Day |
Last modified on
| 2022 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043957
