UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036109 |
|---|---|
| Receipt number | R000041134 |
| Scientific Title | effect of neuromuscular electrical stimulation on glucose level |
| Date of disclosure of the study information | 2019/03/06 |
| Last modified on | 2019/11/28 09:23:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
effect of neuromuscular electrical stimulation on glucose level
Acronym
effect of neuromuscular electrical stimulation on glucose level
Scientific Title
effect of neuromuscular electrical stimulation on glucose level
Scientific Title:Acronym
effect of neuromuscular electrical stimulation on glucose level
Region
| Japan |
Condition
Condition
patients with diabetes melittus
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine the effect of neuromuscular electrical stimulation on glucose level
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
glucose level
Key secondary outcomes
blood metabolic parameters
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
30-min neuromuscular electrical stimulation to both legs
Interventions/Control_2
30-min completed rest
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
*diabetes
*age:40-85 years old
*stable HbA1c during recent 2-3 months
*allowed to perform exercise
Key exclusion criteria
*with pace maker
*dementia
*neuropathy
*severe retinopathy
*hemodialysis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Miyamoto |
Organization
Hyogo University of Health Sciences
Division name
School of Rehabilitation
Zip code
6508530
Address
1-3-6, Minatojima, Chuo-ku, Kobe, Japan
TEL
0783043000
t-miyamoto@huhs.ac.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Miyamoto |
Organization
Hyogo University of Health Sciences
Division name
School of Rehabilitation
Zip code
6508530
Address
1-3-6, Minatojima, Chuo-ku, Kobe, Japan
TEL
0783043000
Homepage URL
t-miyamoto@huhs.ac.jp
Sponsor or person
Institute
Hyogo University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Ikeda Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo University of Health Sciences
Address
1-3-6, Minatojima, Chuo-ku, Kobe, Japan
Tel
0783043000
t-miyamoto@huhs.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
池田病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 06 | 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
| 2018 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 07 | 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
| 2019 | Year | 03 | Month | 06 | Day |
Last modified on
| 2019 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041134
