UMIN-CTR Clinical Trial

Basic information
Public title	Intervention study investigating how blood glucose changes by EMS in dialysis patients suffering from diabetes
Acronym	Intervention study investigating how blood glucose changes by EMS in dialysis patients suffering from diabetes
Scientific Title	New strategy for novel dialysis care using belt-type skeletal muscle electrical stimulation
Scientific Title:Acronym	New strategy for novel dialysis care using belt-type skeletal muscle electrical stimulation
Region	Japan

Condition
Condition	Diabetes Diabetic kidney disease
Classification by specialty	Endocrinology and Metabolism Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of suppressing neuroglycemic effect by neuromuscular electrical stimulation (NMES) after supplemental nutrition intake to dialysis patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Differences from blood glucose levels after dialysis before dialysis, before meals, after meals, 60 minutes, 90 minutes, 120 minutes, after dialysis.
Key secondary outcomes	The mean amplitude of glucose excursion (MAGE) with and without NMES, before dialysis, before meals, after meals, 30 minutes, 60 minutes, 120 minutes, post-dialysis.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The test meal is taken 30 minutes after the start of dialysis, and the test is performed for 30 minutes at the maximum intensity that can withstand NMES from 60 minutes after the start of dialysis.
Interventions/Control_2	30 minutes after the start of dialysis, take a test meal and rest on the bed during NMES.
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with maintenance dialysis due to diabetic kidney and kidney disease at Dokkyo Medical University Nikko Medical Center, who can perform exercise therapy during dialysis. For those who understand and agree with the purpose of the research.
Key exclusion criteria	(A) Patients who have not obtained consent for the study. (B) Patients who have contraindications to EMS use such as pacemaker insertion (skeletal muscle electrical stimulation guidelines) (C) Other patients who are deemed inappropriate by the attending physician for conducting this clinical study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tomoki Middle name Last name Tsurumi
Organization	Dokkyo Medical University Nikko Medical Center
Division name	Department of Rehabilitation
Zip code	321-259
Address	632 Takatoku Nikko, Tochigi Japan
TEL	0288761515
Email	t-tsuru@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Tomoki Middle name Last name Tsurumi
Organization	Dokkyo Medical University Nikko Medical Center
Division name	Department of Rehabilitation
Zip code	321-259
Address	632 Takatoku Nikko, Tochigi Japan
TEL	0288761515
Homepage URL
Email	t-tsuru@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University Nikko Medical Center department of Rehabilitation
Institute
Department

Funding Source
Organization	Japan Society for The Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Dokkyo Medical University Nikko Medical Center
Address	632 Takatoku Nikko, Tochigi Japan
Tel	0288-76-1515
Email	t-tsuru@dokkyomed.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	獨協医科大学日光医療センター（栃木県）

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 31 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	Enrolling by invitation
Date of protocol fixation	2017 Year 07 Month 01 Day
Date of IRB	2017 Year 07 Month 31 Day
Anticipated trial start date	2019 Year 01 Month 04 Day
Last follow-up date	2020 Year 06 Month 30 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 01 Month 29 Day
Last modified on	2020 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044137