NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Healthy person
Date of first enrollment	26/12/2025
Target sample size	20
Countries of recruitment
Study type	Other
Intervention(s)	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 (Otsuka Pharmaceutical - Cambridge Isotope Laboratories) dissolved in 75 mL of purified water ( Otsuka Pharmaceutical) dissolved in 75 mL purified water (Otsuka Pharmaceutical) is ingested orally. At 15, 30, 45, 60, 90, 120, 150, and 180 minutes, subjects exhale approximately 200 mL of breath into a breath collection bag (breath sample collection), and blood is drawn (5 mL of blood at 0 minutes, 2 mL of blood from 14 to 180 minutes) from the elbow vein. Subjects will collect blood samples using an indwelling needle to reduce the number of punctures for a total of 9 blood draws.

Outcome(s)

Primary Outcome	13CO2 exhalation in exhaled breath
Secondary Outcome	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)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 65age old
Gender	Male
Include 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
Exclude 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