UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037507 |
|---|---|
| Receipt number | R000042756 |
| Scientific Title | Relationship between blood pressure fluctuation and blood sugar at standing up |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2019/07/26 23:12:29 |
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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
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
inouemi@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Graduate School of Nursing
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042756
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
