UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between blood pressure fluctuation and blood sugar at standing up -As a basic research for getting out of bed support-
Acronym	Relationship between blood pressure fluctuation and blood sugar at standing up -As a basic research for getting out of bed support-
Scientific Title	Relationship between blood pressure fluctuation and blood sugar at standing up
Scientific Title:Acronym	Relationship between blood pressure fluctuation and blood sugar at standing up
Region	Japan

Condition
Condition	Orthostatic hypotension
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Blood pressure at every heartbeat and at 24-hour continuous blood glucose at the time of standing up are measured, and blood pressure fluctuation at the time of standing up is closely examined in relation to the blood sugar level. Through this analysis, we consider the best method of bed departure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood pressure fluctuation and blood sugar level at standing up
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Blood pressure at every heartbeat and at 24-hour continuous blood glucose at the time of standing up are measured, and blood pressure fluctuation at the time of standing up is closely examined in relation to the blood sugar level.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Person who is 20 years or older at the time of consent acquisition. 2) A person who wears a continuous blood glucose meter (CGM) sensor and can wear it for 9-14 days. 3) A person who received written consent from the person's free will after sufficient explanation after participating in this research.
Key exclusion criteria	1)Person who is pointed out as orthostatic hypotension. 2)Person who is diagnosed with diabetes and is receiving treatment. 3)Person who does not have enough judgment ability. 4)Women who are pregnant or have pregnancy potential. 5)Breastfeeding women. 6)A person who the research director judged inappropriate as a research subject.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Etuko Fujimoto Middle name Last name Woman
Organization	Kansai Medical University Graduate School of Nursing
Division name	Basic nursing field Basic nursing area
Zip code	5731004
Address	2-2,2-chome,hirakatasi,Osaka 573-1004 japan
TEL	072-804-0205
Email	fujimoet@hirakata.kmu.ac.jp

Public contact
Name of contact person	1st name miwa inoue Middle name Last name woman
Organization	Kansai Medical University Graduate School of Nursing
Division name	Basic nursing field Basic nursing area
Zip code	5731004
Address	2-2,2-chome,hirakatasi,Osaka 573-1004 japan
TEL	072-804-0205(4635)
Homepage URL
Email	inouemi@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Graduate School of Nursing
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kansai Medical University Center for Ethical Review
Address	2-2,2-chome,hirakatasi,Osaka 573-1004 japan
Tel	072-804-2440
Email	rinriirb@hirakata.kmu.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	関西医科大学（大阪府）

Other administrative information
Date of disclosure of the study information	2019 Year 08 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
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	Preinitiation
Date of protocol fixation	2019 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 26 Day
Last modified on	2019 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042756