UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062382 |
|---|---|
| Receipt number | R000071393 |
| Scientific Title | Elucidation of functional interactions among the brain, spinal cord, and metabolic organs in glucose metabolism |
| Date of disclosure of the study information | 2026/07/29 |
| Last modified on | 2026/07/29 13:06:16 |
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Basic information
Public title
A study of brain, spinal cord, and organ function after glucose ingestion
Acronym
GBSO (Glucose metabolism, Brain, Spinal cord, and Organs) Study
Scientific Title
Elucidation of functional interactions among the brain, spinal cord, and metabolic organs in glucose metabolism
Scientific Title:Acronym
GBSO (Glucose metabolism, Brain, Spinal cord, and Organs) Study
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To comprehensively investigate the functional interactions among the brain, spinal cord, and metabolism-related organs in response to glucose metabolism
Basic objectives2
Others
Basic objectives -Others
Elucidation of the physiological mechanisms underlying brain-spinal cord-organ functional interactions associated with glucose metabolism.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in brain activity associated with glucose metabolism, measured using MRI
Key secondary outcomes
Changes in organ function associated with glucose metabolism, measured using MRI.
Assessment of spinal and peripheral nerve function associated with glucose metabolism using transcutaneous magnetic stimulation.
Changes in glucose metabolism-related blood test results after glucose intake.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
MRI assessment:
Participants fast for 10 hours before each session. On Day 1, a glucose sensor is attached to the upper arm. After a 15-minute resting baseline, participants ingest 75 g of glucose and remain at rest for 2 hours while glucose responses are recorded. On Days 2 and 3, functional MRI of the brain or organs is performed under glucose and carbonated water control conditions. T2*-weighted images are acquired for 75 minutes. Fifteen minutes after scanning begins, participants ingest glucose solution or carbonated water, and scanning continues for 60 minutes.
Magnetic stimulation assessment:
Participants may undergo transcutaneous magnetic stimulation before and after ingestion of 75 g of glucose to assess spinal and peripheral nerve function. Skin surface potentials, electromyographic and electroencephalographic activity, and stimulation-evoked limb reflexes are recorded. Limb movements are also recorded by motion capture.
In both assessments, glucose-related autonomic and organ responses are evaluated before and after glucose ingestion. A glucose sensor is attached to the upper arm, and blood samples are collected for glucose metabolism-related measurements. If repeated sampling is required on the same day, an intravenous line with normal saline may be used. Blood glucose is also measured with a self-monitoring meter. The total blood volume is limited to 20 mL per experiment per day, and sampling is performed no more than twice per week per participant.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy individuals
Key exclusion criteria
<Common exclusion criteria>
Younger than 18 years or 65 years or older
Body mass index (BMI) below 18.5 or 30.0 or higher
Systolic blood pressure of 140 mmHg or higher
Diastolic blood pressure of 90 mmHg or higher
Regular smoking, defined as smoking at least one cigarette per day
Presence of typical symptoms of diabetes mellitus, including excessive thirst, frequent urination or polyuria, and fatigue
A previous diagnosis of diabetes mellitus during a health checkup or by a physician
<MRI>
Individuals with contraindications to MRI, such as claustrophobia or metallic implants or devices in the body
Individuals identified as having MRI contraindications based on the participant screening questionnaire
Individuals identified as having MRI contraindications based on the checklist completed on the day of MRI scanning
Individuals who experience severe magnetic-field-induced vertigo or in whom structural brain abnormalities are detected after study initiation
<Transcutaneous magnetic stimulation>
Individuals with a history of epilepsy, a cardiac pacemaker, metal implants in the head, or suspected pregnancy.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Nishimura |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Neural Prosthetics Project
Zip code
156-8506
Address
Kamikitazawa 2-1-6, Setagaya-ku, Tokyo, Japan
TEL
03-6834-2375
nppj@igakuken.or.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Tazoe |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Neural Prosthetics Project
Zip code
156-8506
Address
Kamikitazawa 2-1-6, Setagaya-ku, Tokyo, Japan
TEL
03-6379-8411
Homepage URL
nppj@igakuken.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Tokyo Metropolitan Institute of Medical Science Institutional Review Board
Address
Kamikitazawa 2-1-6, Setagaya-ku, Tokyo
Tel
03-5316-3107
hito-rinri@igakuken.or.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 | 07 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 04 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071393
