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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023672
Receipt No. R000026710
Scientific Title Effect on the gastric motor function due to stomach electromyogram using acupuncture in Pancreas kidney simultaneous transplant patients
Date of disclosure of the study information 2016/08/18
Last modified on 2016/08/18

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Basic information
Public title Effect on the gastric motor function due to stomach electromyogram using acupuncture in Pancreas kidney simultaneous transplant patients
Acronym Effect on the gastric motor function due to stomach electromyogram using acupuncture in Pancreas kidney simultaneous transplant patients
Scientific Title Effect on the gastric motor function due to stomach electromyogram using acupuncture in Pancreas kidney simultaneous transplant patients
Scientific Title:Acronym Effect on the gastric motor function due to stomach electromyogram using acupuncture in Pancreas kidney simultaneous transplant patients
Region
Japan

Condition
Condition Type 1 diabetic patient
Classification by specialty
Endocrinology and Metabolism Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Diabetic patients undergoing pancreas transplantation, by the long-term poor glycemic control, but autonomic function there are many examples of the failure with a gastric motility dysfunction, stomach motor function before and after the transplant has not been sufficiently studied. For patients who have been the subject of Pancreas kidney simultaneous transplant by type 1 diabetes this time, together with an evaluation by the stomach electromyography, also be evaluated for gastric motor function improvement effect of acupuncture intervention.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of gastric motor function improvement effect
Analysis by stomach electromyographic
After intervention and before intervention of acupuncture treatment, normal wave, bradygastria, to assess whether or not there is an over time statistically significant difference in tachygastria.
Key secondary outcomes Evaluation of subjective symptoms by the upper gastrointestinal tract symptoms related QOL questionnaire (GSRS)

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Acupuncture

only once

acupuncture points(ST36)
retaining needle 10 minutes
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 Type 1 diabetic patient

Patients after pre-implantation or transplantaitionnnn

Cases of written consent from the pereson was obtained
Key exclusion criteria A person who has a history of organic disease or resection of the upper gastrointestinal tract

By metal allergy, etc., difficult person to undergo acupuncture treatment

In addition to diabetes, a person with a disease causing clearly ataxia of autonomic function

Other cases the doctor has determined unsuitable to participate in this test
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Ohno
Organization Osaka University Graduate School of Medicine
Division name Department of Integrative Medicine
Zip code
Address Suita, Osaka YamadaTakashi 2-2
TEL 06-6879-3498
Email jimu@cam.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keita Taguchi
Organization Osaka University Graduate School of Medicine
Division name Department of Integrative Medicine
Zip code
Address Suita, Osaka YamadaTakashi 2-2
TEL 06-6879-3498
Homepage URL
Email k-taguchi@cam.med.osaka-u.ac.jp

Sponsor
Institute Department of Integrative Medicine, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization self funding

Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 18 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
2016 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 18 Day
Last modified on
2016 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026710

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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