UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058491 |
|---|---|
| Receipt number | R000066817 |
| Scientific Title | Effects of short term training on circulatory responses and muscle oxygenation during postprandial hyperglycemia |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/16 14:50:12 |
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Basic information
Public title
Effects of short term training on circulatory responses and muscle oxygenation during postprandial hyperglycemia
Acronym
Effects of short term training on circulatory responses and muscle oxygenation during postprandial hyperglycemia
Scientific Title
Effects of short term training on circulatory responses and muscle oxygenation during postprandial hyperglycemia
Scientific Title:Acronym
Effects of short term training on circulatory responses and muscle oxygenation during postprandial hyperglycemia
Region
| Japan |
Condition
Condition
Postprandial hyperglycemia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether short term training can improve the impaired circulatory responses, muscle blood flow, and muscle oxygenation caused by postprandial hyperglycemia during exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle oxygen dynamics (Oxyhemoglobin, Deoxyhemoglobin, Total hemoglobin)
Key secondary outcomes
Blood glucose level
Brachial artery diameter and blood flow velocity
Heart rate
Blood pressure
Stroke volume
Cardiac output
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Aerobic training was performed in the training room using an ergometer and treadmill at 60 to 75% of heart rate reserve (HRR) for 60 minutes per session, conducted over 7 days.
Interventions/Control_2
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy young adults with normal fasting glucose levels.
Key exclusion criteria
Individuals currently diagnosed with or receiving treatment for any of the following conditions: cerebrovascular disease, heart disease, restrictive or obstructive ventilatory disorders, neurological disorders that interfere with exercise in this study, or metabolic disorders including diabetes mellitus.
Individuals with a body mass index (BMI) of 30 or higher, or below 18.5.
Individuals with resting blood pressure of 160/100 mmHg or higher, or 100/60 mmHg or lower.
Individuals engaging in moderate or higher intensity exercise five or more times per week.
(For females only) Individuals currently pregnant or breastfeeding.
(For females only) Individuals with a history or current diagnosis of gynecological disorders.
(For females only) Individuals currently undergoing hormone therapy
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Erika |
| Middle name | |
| Last name | Iwamoto |
Organization
Sapporo Medical University
Division name
Department of Physical Therapy, School of Health Science
Zip code
060-8556
Address
17 Chome Minami 1 Jo Nishi
TEL
09086336514
t.arata@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Erika |
| Middle name | |
| Last name | Iwamoto |
Organization
Sapporo Medical University
Division name
Department of Physical Therapy, School of Health Science
Zip code
060-8556
Address
17 Chome Minami 1 Jo Nishi
TEL
011-611-2111
Homepage URL
e.iwamoto@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
No organization
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
Sapporo Medical University Ethics Committee
Address
17 Chome Minami 1 Jo Nishi
Tel
011-611-2111
rinri@sapmed.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
| 2025 | Year | 08 | Month | 01 | 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
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study has been submitted to the ethics review committee as a single application that includes multiple research components. This registration corresponds to Study C within that application, and the information will be updated following approval by the ethics committee.
Management information
Registered date
| 2025 | Year | 07 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066817
