Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Status and phase: Completed; Phase 4

Conditions: Hypopituitarism

Treatments: Drug: Intranasal glugagon; Drug: Intranasal placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05206149

GST-intranasale

Details and patient eligibility

About

The diagnosis of secondary hypoadrenalism and GH deficiency (GHD) often requires the performance of a dynamic test. The glucagon stimulation test (GST) is one of the options for evaluating hypothalamic-pituitary function, representing a stimulus for both the corticotropic and somatotropic axis, substantially safe and easily available. The standard procedure involves the intramuscular injection of 1-1.5 mg of glucagon based on the patient's weight.

In addition to its antero-pituitary function, glucagon has also shown its ability to stimulate neurohypophyseal secretion. Using the copeptin dosage, it has been shown that after the administration of glucagon in healthy subjects there is a significant release of ADH. However, the available data are scarse and there is no standardized protocol for the use of the glucagon test in diabetes insipidus.

At the moment, GST is not the most frequently chosen diagnostic option. In fact, despite having the advantage of being able to investigate different areas of anterohypophyseal and probably posterohypophyseal function at the same time, the test has some disadvantages: the prolonged duration makes the procedure challenging, the intramuscular injection can be unwelcome, and many variables can come into play in the definition of a normal response (age, BMI, glycemic status).

The recent introduction of a single-dose nasal powder formulation (Baqsimi®) could overcome some of the limitations of classic GST and make the procedure less demanding.

To date, no assessments are yet available regarding a purely diagnostic role in the context of hypopituitarism of this new formulation.

Through the knowledge of the physiological response of the adrenocortical, somatotropic and ADH axis to the administration of intranasal glucagon in healthy subjects, it will be possible to evaluate its possible application in the diagnosis of GH deficiency, central adrenal insufficiency and possibly diabetes insipidus.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any adult healthy subject (age >= 18 years old) and not meeting the exclusion criteria listed below

Exclusion criteria

• BMI < 18.5 kg/m2 or > 25 kg/m2
• Any active pharmacological treatment
• Pregnancy or breastfeeding

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

Intranasal Administration of Glucagon

Experimental group

Description:

Intranasal administration of glucagon in healthy subjects

Treatment:

Drug: Intranasal glugagon

Intranasal Administration of Placebo

Placebo Comparator group

Description:

Intranasal administration of placebo (isotonic saline solution) in healthy subjects

Treatment:

Drug: Intranasal placebo