UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between vascular function and health checkup data in local residents
Acronym	The relationship between vascular function and health checkup data in local residents
Scientific Title	The relationship between vascular function and health checkup data in local residents
Scientific Title:Acronym	The relationship between vascular function and health checkup data in local residents
Region	Japan

Condition
Condition	Vascular dysfunction Frailty
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The primary objective is to evaluate the relationship of vascular dysfunction with flailty onset using health examination data.
Basic objectives2	Others
Basic objectives -Others	Factors for predicting vascular dysfunction and flailty onset
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of flailty
Key secondary outcomes	1) Development of renal dysfunction 2) Incident of metabolic syndrome

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	The subjects who have two days medical health checkup at Gunma chuo hospital
Key exclusion criteria	The subjects who do not agree to participate in this study
Target sample size	1000

Research contact person
Last name of lead principal investigator	1st name Yoshiaki Middle name Last name Ohyama
Organization	Gunma University Hospital
Division name	Clinical Investigation and Research Unit
Zip code	3710034
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL	0272208740
Email	yoshiaki-ohyama@gunma-u.ac.jp

Public contact
1st name of contact person	1st name Mie Middle name Last name Araki
Organization	Japan Community Health care Organization Gunma Chuo Hospital
Division name	Department of Pharmacy
Zip code	3710025
Address	1-7-13 Kouncho, Maebashi, Gunma, Japan
TEL	0272218165
Homepage URL
Email	araki-mie@gunma.jcho.go.jp

Sponsor
Institute	Japan Community Health care Organization Gunma Chuo Hospital
Institute
Department

Funding Source
Organization	Japan Society For Promotion Of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Takasaki University of Health and Welfare
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japan Community Health care Organization Gunma Chuo Hospita
Address	1-7-13 Kouncho, Maebashi, Gunma, Japan
Tel	0272218165
Email	chiken@gunma.jcho.go.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 05 Month 16 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	2019 Year 01 Month 09 Day
Date of IRB	2019 Year 02 Month 07 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Observational study consisting of cross-sectional study followed by longitudinal study. In addition to the usual health checkup data, the next check is performed. CAVI (Cardio Ankle Vascular Index), ABI (Ankle Brachial Pressure Index), urinary sodium concentration, urinary creatinine, central blood pressure, 24-hour blood pressure, medication survey, activity survey, preference survey, flail index test

Management information
Registered date	2019 Year 05 Month 15 Day
Last modified on	2019 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041883