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Glucose metabolism assessment method with oral glucose tolerance test with breath test

Glucose metabolism assessment method combining the oral 75g glucose tolerance test with the 13C-glucose breath test in healthy subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Unknown
Source
JPRN
Registry ID
JPRN-jRCTs021250040
Enrollment
20
Registered
2025-12-26
Start date
2025-12-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy person

Interventions

An oral glucose load of 75.5 g is administered early in the morning on an empty stomach: 150 mL of a 50% glucose solution containing 75 g glucose (Otsuka Pharmaceutical) and 0.5 g 13C-labeled glucose

Sponsors

Sawada Shojiro
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Healthy male adult Between 20 and 65 years of age at the time consent is obtained Those understand the explanation of study participation and sign a written consent form

Exclusion criteria

Exclusion criteria: Those having diseases that affect glucose metabolism (diabetes, thyroid disease, liver dysfunction, renal dysfunction, under steroid treatment, cancer, etc.) Those suggestive of hypotonic dehydration (physical condition on the day of examination will be interviewed to determine whether there is fatigue, dry mouth, decreased urine output, or loss of electrolytes due to fever, diarrhea, vomiting, etc.) Body mass index (BMI) of 30 or higher At least 110 mg/dL measured with a simple blood glucose meter before this test Taking any medication Those who the investigator deems inappropriate for the subject of this study

Design outcomes

Primary

MeasureTime frame
13CO2 exhalation in exhaled breath

Secondary

MeasureTime frame
Association of 13CO2 expiratory excretion in breath with insulin secretory capacity (HOMA beta), insulin resistance (HOMA-IR), and hepatic insulin clearance (C-peptide/insulin ratio)

Contacts

Public ContactShojiro Sawada

Tohoku Medical and Pharmaceutical University Hospital

ssawada@tohoku-mpu.ac.jp+81-22-259-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026