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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040016
Receipt No. R000045305
Scientific Title Active stand up test
Date of disclosure of the study information 2020/04/08
Last modified on 2020/04/06

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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
Email 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
Email chouk@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University Graduate Sc hool of Nursing
Institute
Department

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045305

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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