UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058494 |
|---|---|
| Receipt number | R000066872 |
| Scientific Title | Effects of glucose loading on muscle oxygenation during resistance exercise |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/16 14:50:57 |
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Basic information
Public title
Effects of glucose loading on muscle oxygenation during resistance exercise
Acronym
Effects of glucose loading on muscle oxygenation during resistance exercise
Scientific Title
Effects of glucose loading on muscle oxygenation during resistance exercise
Scientific Title:Acronym
Effects of glucose loading on muscle oxygenation during resistance exercise
Region
| Japan |
Condition
Condition
Postprandial hyperglycemia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of postprandial hyperglycemia on muscle oxygenation in active muscles and its relationship with the pressor response 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
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Glucose loading
Interventions/Control_2
Fructose loading
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Young and middle-aged men and women with normal fasting blood glucose levels
Key exclusion criteria
Individuals currently diagnosed with, having a history of, or receiving treatment for any of the following:
cerebrovascular disease
heart disease
restrictive or obstructive ventilatory disorders
neurological disorders that interfere with exercise performance
diabetes mellitus, or HbA1c >= 6.5%
metabolic disorders including dyslipidemia and hyperuricemia
Individuals with BMI >= 30 or < 18.5
Individuals with resting blood pressure >= 160/100 mmHg or <= 100/60 mmHg
Individuals who perform moderate or higher intensity exercise more than 5 times per week
(Females only) Individuals who are currently pregnant or breastfeeding
(Females only) Individuals with a history or current diagnosis of gynecological disorders
(Females only) Individuals currently receiving hormone therapy including hormone replacement therapy for menopausal symptoms
Target sample size
30
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 A 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=R000066872
