An exploratory clinical trial to elucidate the mechanism of glucose metabolism regulation using graduated hyperglycemic clamp method in non-diabetic subjects

UMIN ID: UMIN000056109

Registered date:08/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Non-diabetes
• Date of first enrollment: 2025/01/01
• Target sample size: 7
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Performing a glucose clamp test on non-diabetic individuals

Outcome(s)

• Primary Outcome: Examination of fitting of a novel mathematical model incorporating glucose effectiveness
• Secondary Outcome: Relevance of insulin action on elevated blood glucose

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) The individuals who are taking drugs that affect glucose metabolism (steroids, immunosuppressants, beta-blockers) (2) pregnant or possibly pregnant (3) The individuals who are breast-feeding (4) The individuals have a known history of hypersensitivity to the test drug or the ingredients in the test (5) The individuals who have received a cardiac function classification of 3 or 4 by NYHA within the last 1 year (6) The individuals who have been diagnosed with severe renal dysfunction (eGFR 30 mL/min/1.73 m2 or less) within the last 1 year (7) Persons with blood clotting abnormalities (8) The individuals who have been diagnosed with thyroid function abnormalities or electrolyte within the last 1 year (9) In addition, when the principal investigator deems the patient to be inappropriate as a subject

Related Information

• Primary Sponsor: Kobe university
• Source(s) of Monetary Support: Others