UMIN-CTR Clinical Trial

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
Email	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
Email	ky7527@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Shizuoka General Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043957