UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063009 |
|---|---|
| Receipt number | R000072135 |
| Scientific Title | Effects of Brief Postprandial Exercise Involving Large Lower-Limb Muscle Groups on Postprandial Blood Glucose Dynamics: A Crossover Study |
| Date of disclosure of the study information | 2026/09/22 |
| Last modified on | 2026/09/21 14:32:17 |
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Basic information
Public title
Effects of Brief Postprandial Exercise Involving Large Lower-Limb Muscle Groups on Postprandial Blood Glucose Dynamics: A Crossover Study
Acronym
Effects of Brief Postprandial Exercise Involving Large Lower-Limb Muscle Groups on Postprandial Blood Glucose Dynamics: A Crossover Study
Scientific Title
Effects of Brief Postprandial Exercise Involving Large Lower-Limb Muscle Groups on Postprandial Blood Glucose Dynamics: A Crossover Study
Scientific Title:Acronym
Effects of Brief Postprandial Exercise Involving Large Lower-Limb Muscle Groups on Postprandial Blood Glucose Dynamics: A Crossover Study
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate, using a continuous glucose monitoring device, the effects of 3 minutes of postprandial squat exercise on postprandial blood glucose dynamics compared with seated rest in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incremental area under the postprandial blood glucose curve (iAUC) from 0 to 120 minutes after the meal, calculated from blood glucose values measured using FreeStyle Libre.
Key secondary outcomes
Postprandial blood glucose peak value (Cmax), time to peak (Tmax), percentage of time with blood glucose greater than or equal to 140 mg/dL (TAR greater than or equal to 140), percentage of time within the target range (TIR 70 to 140 mg/dL), time below range (TBR less than 70 mg/dL), and hypoglycemic symptoms will be evaluated as indicators of postprandial blood glucose dynamics to examine the effects of squat exercise on postprandial blood glucose dynamics.
Ease of performance will be evaluated using a 5-point Likert scale to assess the feasibility of squat exercise.
The rating of perceived exertion (RPE) will be used to evaluate the subjective exercise load during squat exercise.
A numerical rating scale (NRS) will be used to evaluate knee pain and muscle pain associated with squat exercise.
Intention to continue will be evaluated using a 5-point Likert scale to assess the sustainability of squat exercise.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention : Three minutes of squat exercise will be performed 15 minutes after completion of the meal, and participants will remain seated at rest for the remainder of the 120-minute postprandial period.
Interventions/Control_2
Control condition: Participants will remain seated at rest for 120 minutes after completion of the meal.
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
| 28 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have received sufficient explanation about the purpose and contents of this research, have the ability to consent, volunteered voluntarily after fully understanding, and agreed to participate in writing.
Key exclusion criteria
Exclusion criteria for study participation are as follows:
(1) Individuals diagnosed with diabetes mellitus
(2) Individuals receiving treatment for abnormal glucose metabolism or endocrine disorders
(3) Individuals with pain in the knees, lower back, or other musculoskeletal regions that makes performing squat exercise difficult
(4) Individuals who have been advised by a physician to restrict physical activity
(5) Individuals deemed inappropriate for participation by the principal investigator for safety reasons
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Laboratory of Clinical Pharmacy
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
n-wakui@hoshi.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Laboratory of Clinical Pharmacy
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
Homepage URL
n-wakui@hoshi.ac.jp
Sponsor or person
Institute
Hoshi University
Institute
Department
Personal name
Funding Source
Organization
Hoshi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Hoshi University
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
Tel
03-3786-1011
y-hashiguchi@hoshi.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 | 09 | Month | 22 | 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
24
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 25 | 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 | 09 | Month | 21 | Day |
Last modified on
| 2026 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072135
