UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039310 |
|---|---|
| Receipt number | R000044137 |
| Scientific Title | New strategy for novel dialysis care using belt-type skeletal muscle electrical stimulation |
| Date of disclosure of the study information | 2020/01/31 |
| Last modified on | 2020/01/29 18:10:25 |
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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
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
t-tsuru@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center department of Rehabilitation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044137
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
