UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055323 |
|---|---|
| Receipt number | R000063217 |
| Scientific Title | Development of a new protective strategy to prevent postprandial hyperglycemia and microvascular dysfunction during prolonged sitting using belt electrode skeletal muscle electrical stimulation |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2024/08/23 16:16:52 |
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Basic information
Public title
Development of a new protective strategy to prevent microvascular dysfunction using belt electrode skeletal muscle electrical stimulation
Acronym
Development of new protective strategies to prevent microvascular dysfunction
Scientific Title
Development of a new protective strategy to prevent postprandial hyperglycemia and microvascular dysfunction during prolonged sitting using belt electrode skeletal muscle electrical stimulation
Scientific Title:Acronym
Development of a new protective strategy to prevent postprandial hyperglycemia and microvascular dysfunction during prolonged sitting.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of skeletal muscle electrical stimulation on postprandial hyperglycemia and microvascular function during prolonged sitting.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level before, 30, 60, 120, and 150 minutes after a meal
Microvascular function before and 150 minutes after a meal
Key secondary outcomes
d-ROM and BAP before, 60 min and 150 min after meal
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Spend 150 minutes in the chair-sitting position after 30 minutes in the resting supine position.
Interventions/Control_2
Spend 150 minutes in a chair-sitting position after 30 minutes of aerobic exercise.
Interventions/Control_3
Spend 150 minutes in a chair-sitting position after 30 minutes of electrical stimulation of skeletal muscles.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
18 years of age or older and under 30 years of age.
BMI greater than 18 and less than 25 kg/m2
Key exclusion criteria
Persons with a history of cardio-metabolic or metabolic disease.
Those who are on drug therapy.
Taking dietary supplements.
Patients who have a regular exercise routine.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Tamiya |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
0252574723
tamiya@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Tamiya |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
0252574723
Homepage URL
tamiya@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel
0252574455
rinri@nuhw.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 30 | 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
| 2024 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 08 | Month | 23 | Day |
Last modified on
| 2024 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063217
