UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect on the gastric motor function due to stomach electromyogram using acupuncture in Pancreas kidney simultaneous transplant patients
Title of the study (Brief title)	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	Satoshi Ohno
Organization	Osaka University Graduate School of Medicine
Division name	Department of Integrative Medicine
Address	Suita, Osaka YamadaTakashi 2-2
TEL	06-6879-3498
Email	jimu@cam.med.osaka-u.ac.jp

Public contact
Name of contact person	Keita Taguchi
Organization	Osaka University Graduate School of Medicine
Division name	Department of Integrative Medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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