Tokyo, July 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062382) titled 'A study of brain, spinal cord, and organ function after glucose ingestion' on July 29.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Tokyo Metropolitan Institute of Medical Science

Condition: Condition - Diabetes mellitus Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Healthy individuals Key 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

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

Individuals with a history of epilepsy, a cardiac pacemaker, metal implants in the head, or suspected pregnancy. Target Size - 60

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071393

Disclaimer: Curated by HT Syndication.