UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040016 |
|---|---|
| Receipt number | R000045305 |
| Scientific Title | Active stand up test |
| Date of disclosure of the study information | 2020/04/08 |
| Last modified on | 2020/04/06 17:34:55 |
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Basic information
Public title
An exploratory study on the timing of promoting activity in type 2 diabetes patients
-Focusing on dietary and orthostatic hypotension-
Acronym
An exploratory study on the timing of promoting activity in type 2 diabetes patients
-Focusing on dietary and orthostatic hypotension-
Scientific Title
Active stand up test
Scientific Title:Acronym
Active stand up test
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
From the viewpoint of nursing, it is to search the standing support method in which type 2 diabetic patient does not cause the hypotension after the meal. Especially, it is necessary to pay attention to the relationship with meal time. In addition, it is examined whether the situation of the blood pressure becomes the case in which the patient who has the hypotension is settled.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure fluctuation
Key secondary outcomes
Collect information from pulse, respiratory rate, cardiac output, subjective symptoms during standing load, and electronic medical records
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Active standing test examines the relationship between blood pressure variability and diet
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) persons who are over 20 years of age at the time of obtaining consent
2) a person who is independent of daily life
3) history of type 2 diabetes
4) after receiving the explanation for participation in this research, a person who has obtained a document agreement by his / her free will
5) a person who has obtained permission for research participation from a medical doctor
Key exclusion criteria
1) Those who take drugs (such as beta blockers) that suppress the autonomic nervous system
2) Women who are or may be pregnant
3) Patients who have a history of gastrectomy or who have a gastric catheter
4) Persons who have difficulty in oral intake
5) Others who are judged inappropriate by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Fujimoto |
Organization
Kansai Medical University Graduate School of Nursing
Division name
Basic nursing field Basic nursing area
Zip code
573-1004
Address
2-2,2-chome,hirakatasi,Osaka 573-1004 japan
TEL
072-804-0101
fujimoet@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Keiha |
| Middle name | |
| Last name | Chou |
Organization
Kansai Medical University Graduate School of Nursing
Division name
Basic nursing field Basic nursing area
Zip code
573-1004
Address
2-2,2-chome,hirakatasi,Osaka 573-1004 japan
TEL
072-804-0101
Homepage URL
chouk@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Graduate Sc hool of Nursing
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University Graduate Sc hool of Nursing
Organization
Division
Category of Funding Organization
Other
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
関西医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 08 | 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
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 03 | Month | 31 | Day |
Last modified on
| 2020 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045305
| 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 |
