Evaluation of the usefulness of new functional tests using insulin and glucagon

Evaluation of the usefulness of new functional tests using insulin and glucagon - Evaluation of the usefulness of new functional tests using insulin and glucagon

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051413

Enrollment

600

Registered

2023-06-23

Start date

2022-10-02

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

endocrine and metabolic disorder

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. When an arginine tolerance test is required due to suspected adult growth hormone deficiency or a peripheral rapid calcium tolerance test is required due to suspected insulinoma or medullary thyroid carcinoma in the usual course of medical care. 2. Diagnosis of glucose intolerance, diabetes mellitus, reactive hypoglycemia, insulinoma, or glucagonoma by functional and imaging tests at the hospital, the Department 4. Patients must have maintained the function of major organs (listed below) on the clinical examination within 30 days prior to enrollment. 5. Patients who have given a full explanation of their participation in this study, and who have given written consent of their own free will based on sufficient understanding.

Exclusion criteria

Exclusion criteria: 1) Within 2 months of last use of somatostatin receptor analogs. 2) In case of severe infection, before or after surgery, or serious trauma. 3) Other cases in which the principal investigator or subinvestigator determines that the subject is inappropriate for this study. 4) When arginine tolerance test and rapid peripheral calcium tolerance test are not necessary under normal medical practice.

Design outcomes

Primary

Measure	Time frame
Association of arginine loading test and rapid calcium loading test results with changes in HbA1c levels Glucose, insulin, and glucagon responses after calcium injection (0,3,6,10 min) and arginine injection (0,30,60,90,120 min).	—

Secondary

Measure	Time frame
1. Changes in blood pressure and pulse rate 2. Changes in blood glucose and insulin sensitivity (FPG, GA, IRI, HOMA-R, QUICKI, CPI) 3. Changes in lipids (total cholesterol, HDL cholesterol, triglycerides) 4. Changes in renal function and electrolytes (BUN, Cre, Na, K, Cl, urinary Cr, urinary albumin) 5. Bone effects (ALP, Ca, iP) and changes 6. Evaluation of safety and adverse events (Ht, Na, BUN, glycemic status, adverse events associated with drug administration)	—

Measure

Time frame

1. Changes in blood pressure and pulse rate 2. Changes in blood glucose and insulin sensitivity (FPG, GA, IRI, HOMA-R, QUICKI, CPI) 3. Changes in lipids (total cholesterol, HDL cholesterol, triglycerides) 4. Changes in renal function and electrolytes (BUN, Cre, Na, K, Cl, urinary Cr, urinary albumin) 5. Bone effects (ALP, Ca, iP) and changes 6. Evaluation of safety and adverse events (Ht, Na, BUN, glycemic status, adverse events associated with drug administration)

—

Countries

Japan

Contacts

Public ContactYumie Takeshita

Kanazawa university hospital Department of Endocrinology and metabolism

takeshita@m-kanazawa.jp076-265-2711

Outcome results