UMIN-CTR Clinical Trial

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