Prospective study of glucagon and incretin secretion in patients with diabetes

UMIN ID: UMIN000055737

Registered date:01/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diabetes
• Date of first enrollment: 2021/09/10
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Arginine 30 g IV over 30 minutes and measure blood glucose, insulin, C-peptide, glucagon, GLP-1, and GIP before loading, 10, 20, 30, 40, 50, 60, 90, and 120 minutes.

Outcome(s)

• Primary Outcome: Increment of glucagon and GLP-1 secretion by arginine stimulation test
• Secondary Outcome: Correlation between increment of glucagon or GLP-1 and HbA1c, age, gender, clinical indices such as diabetes mellitus type, disease duration, blood pressure, and laboratory tests (blood count, blood glucose, Cre, BUN, uric acid, AST, ALT, ALP, gamma-GTP, LDH, CK, TP, Alb, T-Cho, LDL-C, HDL-C, TG, Amy, Lipa, T-Bil, Na, K, Cl, Ca, urine qualitative, urine sediment, urine protein, urine Alb /Cre as examined at the examination)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: (1) Persons strongly suspected of suffering from dementia or psychiatric disorders (2) Those who are using drugs that affect glucagon and GLP-1 secretion, such as GLP-1 receptor agonists, SGLT2 inhibitors, and DPP-4 inhibitors. (3) Persons with severe renal or hepatic dysfunction (4) Persons with bronchial asthma that is difficult to control (5) Persons deemed inappropriate for this clinical research by the Principal Investigator or a Research Supervisor.

Related Information

• Primary Sponsor: Kansai Medical Net Corporation (Kansai Electric Power Medical Research Institute)
• Source(s) of Monetary Support: Kansai Medical Net Corporation (Kansai Electric Power Medical Research Institute)