UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062591 |
|---|---|
| Receipt number | R000071645 |
| Scientific Title | Effect of Intermittent Leg Fidgeting on Daily Time in Tight Range (TITR) in Young Adults with Postprandial Glucose Spikes: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/08/17 |
| Last modified on | 2026/08/17 10:34:00 |
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Basic information
Public title
Effect of Intermittent Leg Fidgeting on Daily Time in Tight Range (TITR) in Young Adults with Postprandial Glucose Spikes: A Randomized Crossover Trial
Acronym
Effect of Leg Fidgeting on Daily Time in Tight Range (TITR)
Scientific Title
Effect of Intermittent Leg Fidgeting on Daily Time in Tight Range (TITR) in Young Adults with Postprandial Glucose Spikes: A Randomized Crossover Trial
Scientific Title:Acronym
Effect of Intermittent Leg Fidgeting on Daily Time in Tight Range (TITR)
Region
| Japan |
Condition
Condition
Young Adults with Postprandial Glucose Spikes
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of intermittent fidgeting on time-in-tight-range (TITR) in young adult males with postprandial glucose spikes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
24-hour Time-in-Tight-Range (TITR)
Key secondary outcomes
8.5-hour Time-in-Tight-Range (TITR)
Postprandial glucose concentrations (mean glucose concentration, peak glucose concentration, 2-hour incremental area under the curve [iAUC])
Time-in-Range (TIR)
Time-Above-Range (TAR)
Time-Below-Range (TBR)
24-hour coefficient of variation (CV) for glucose on the experimental day
24-hour mean glucose level
Physical activity level
Heart rate (HR)
Cardiac parasympathetic nervous activity
Blood pressure (BP)
Rating of perceived exertion (RPE)
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
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Performing intermittent leg fidgeting every 30 minutes over an 8.5-hour period
Interventions/Control_2
Remain in a seated resting position over an 8.5-hour period
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
Young adults with no exercise habits
Those who agreed to the aims of this study
Those who agreed to the objectives and content of this study
Key exclusion criteria
Individuals with a history of diabetes
Individuals diagnosed with cardiovascular diseases during health checkups that may interfere with performing leg fidgeting
Individuals with musculoskeletal disorders in the lower limbs that may hinder performing leg fidgeting
Current smokers
Individuals with a known allergy or hypersensitivity to alcohol
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Izawa |
Organization
Kobe University Graduate School of Medicine
Division name
Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo, JAPAN
TEL
078-796-4566
izawapk@harbor.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Ono |
Organization
Kobe University Graduate School of Medicine
Division name
Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo, JAPAN
TEL
078-796-4515
Homepage URL
onoku@tiger.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Graduate School of Medicine, Kobe University (Myoudani Campus)
Address
7-10-2 Tomogaoka, Suma, Kobe, 654-0142, JAPAN
Tel
078-796-4502
syomu2@ams.kobe-u.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
| 2026 | Year | 08 | Month | 17 | 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
| 2026 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 08 | Month | 17 | Day |
Last modified on
| 2026 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071645
