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

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ClinicalTrials.gov Identifier: NCT05206149
Recruitment Status : Completed
First Posted : January 25, 2022
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
Ezio Ghigo, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hypopituitarism Drug: Intranasal glugagon Drug: Intranasal placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes
Actual Study Start Date : October 1, 2021
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: Intranasal Administration of Glucagon
Intranasal administration of glucagon in healthy subjects
Drug: Intranasal glugagon
Intranasal glucagon is administered at the dose of 3 mg. This corresponds to the administration of a single dose of Baqsimi®.
Other Name: Baqsimi®

Placebo Comparator: Intranasal Administration of Placebo
Intranasal administration of placebo (isotonic saline solution) in healthy subjects
Drug: Intranasal placebo
Intranasal placebo (represented by isotonic saline solution) is administered.




Primary Outcome Measures :
  1. Change in serum ACTH levels between baseline and 15 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.

  2. Change in serum ACTH levels between baseline and 30 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.

  3. Change in serum ACTH levels between baseline and 45 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.

  4. Change in serum ACTH levels between baseline and 60 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.

  5. Change in serum ACTH levels between baseline and 75 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.

  6. Change in serum ACTH levels between baseline and 90 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.

  7. Change in serum ACTH levels between baseline and 120 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.

  8. Change in serum ACTH levels between baseline and 150 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.

  9. Change in serum ACTH levels between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum ACTH (ng/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.

  10. Change in serum cortisol levels between baseline and 15 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.

  11. Change in serum cortisol levels between baseline and 30 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.

  12. Change in serum cortisol levels between baseline and 45 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.

  13. Change in serum cortisol levels between baseline and 60 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.

  14. Change in serum cortisol levels between baseline and 75 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.

  15. Change in serum cortisol levels between baseline and 90 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.

  16. Change in serum cortisol levels between baseline and 120 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.

  17. Change in serum cortisol levels between baseline and 150 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.

  18. Change in serum cortisol levels between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response of the corticotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum cortisol (µg/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.

  19. Change in serum GH levels between baseline and 15 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration ]
    The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.

  20. Change in serum GH levels between baseline and 30 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration ]
    The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.

  21. Change in serum GH levels between baseline and 45 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration ]
    The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.

  22. Change in serum GH levels between baseline and 60 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration ]
    The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.

  23. Change in serum GH levels between baseline and 75 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration ]
    The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.

  24. Change in serum GH levels between baseline and 90 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration ]
    The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.

  25. Change in serum GH levels between baseline and 120 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration ]
    The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.

  26. Change in serum GH levels between baseline and 150 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration ]
    The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.

  27. Change in serum GH levels between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response of the somatotroph axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring serum GH (µg/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.

  28. Change in plasma copeptin levels between baseline and 15 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration ]
    The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.

  29. Change in plasma copeptin levels between baseline and 30 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration ]
    The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.

  30. Change in plasma copeptin levels between baseline and 45 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration ]
    The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.

  31. Change in plasma copeptin levels between baseline and 60 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration ]
    The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.

  32. Change in plasma copeptin levels between baseline and 75 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration ]
    The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.

  33. Change in plasma copeptin levels between baseline and 90 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration ]
    The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.

  34. Change in plasma copeptin levels between baseline and 120 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration ]
    The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.

  35. Change in plasma copeptin levels between baseline and 150 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration ]
    The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.

  36. Change in plasma copeptin levels between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response of the antidiuretic axis to the administration of intranasal glucagon, compared to placebo, was evaluated by measuring plasma copeptin (pmol/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.


Secondary Outcome Measures :
  1. Change in serum sodium levels between baseline and 15 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.

  2. Change in serum sodium levels between baseline and 30 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.

  3. Change in serum sodium levels between baseline and 45 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.

  4. Change in serum sodium levels between baseline and 60 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.

  5. Change in serum sodium levels between baseline and 75 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.

  6. Change in serum sodium levels between baseline and 90 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.

  7. Change in serum sodium levels between baseline and 120 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.

  8. Change in serum sodium levels between baseline and 150 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.

  9. Change in serum sodium levels between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum sodium (mmol/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.

  10. Change in serum potassium levels between baseline and 15 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.

  11. Change in serum potassium levels between baseline and 30 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.

  12. Change in serum potassium levels between baseline and 45 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.

  13. Change in serum potassium levels between baseline and 60 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.

  14. Change in serum potassium levels between baseline and 75 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.

  15. Change in serum potassium levels between baseline and 90 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.

  16. Change in serum potassium levels between baseline and 120 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.

  17. Change in serum potassium levels between baseline and 150 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.

  18. Change in serum potassium levels between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum potassium (mmol/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.

  19. Change in plasma osmolality between baseline and 15 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.

  20. Change in plasma osmolality between baseline and 30 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.

  21. Change in plasma osmolality between baseline and 45 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.

  22. Change in plasma osmolality between baseline and 60 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.

  23. Change in plasma osmolality between baseline and 75 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.

  24. Change in plasma osmolality between baseline and 90 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.

  25. Change in plasma osmolality between baseline and 120 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.

  26. Change in plasma osmolality between baseline and 150 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.

  27. Change in plasma osmolality between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma osmolality (mOsm/kg) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.

  28. Change in serum glucose levels between baseline and 15 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.

  29. Change in serum glucose levels between baseline and 30 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.

  30. Change in serum glucose levels between baseline and 45 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.

  31. Change in serum glucose levels between baseline and 60 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.

  32. Change in serum glucose levels between baseline and 75 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.

  33. Change in serum glucose levels between baseline and 90 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.

  34. Change in serum glucose levels between baseline and 120 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.

  35. Change in serum glucose levels between baseline and 150 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.

  36. Change in serum glucose levels between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring serum glucose (mg/dl) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.

  37. Change in plasma insulin levels between baseline and 15 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 15 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 15 minutes from glucagon/placebo administration.

  38. Change in plasma insulin levels between baseline and 30 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 30 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 30 minutes from glucagon/placebo administration.

  39. Change in plasma insulin levels between baseline and 45 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 45 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 45 minutes from glucagon/placebo administration.

  40. Change in plasma insulin levels between baseline and 60 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 60 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 60 minutes from glucagon/placebo administration.

  41. Change in plasma insulin levels between baseline and 75 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 75 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 75 minutes from glucagon/placebo administration.

  42. Change in plasma insulin levels between baseline and 90 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 90 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 90 minutes from glucagon/placebo administration.

  43. Change in plasma insulin levels between baseline and 120 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 120 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 120 minutes from glucagon/placebo administration.

  44. Change in plasma insulin levels between baseline and 150 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 150 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 150 minutes from glucagon/placebo administration.

  45. Change in plasma insulin levels between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring plasma insulin (mU/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.

  46. Change in urine sodium levels between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring urine sodium (mmol/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.

  47. Change in urine potassium levels between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring urine potassium (mmol/L) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.

  48. Change in urine creatinine levels between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring urine creatinine (mg/dl) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.

  49. Change in urine osmolality between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of glycometabolic and hydro-electrolyte biochemical balance was evaluated by measuring urine osmolality (mOsm/kg) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.

  50. Change in resistance at bioimpedance vector analysis between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of bioimpedance vector analysis (BIVA) was evaluated by measuring resistance (Ohm) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.

  51. Change in reactance at bioimpedance vector analysis between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of bioimpedance vector analysis (BIVA) was evaluated by measuring reactance (Ohm) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.

  52. Change in phase angle at bioimpedance vector analysis between baseline and 180 minutes after glucagon/placebo administration [ Time Frame: From baseline (0 minutes) to 180 minutes after glucagon/placebo administration ]
    The response to the administration of intranasal glucagon, compared to placebo, in terms of bioimpedance vector analysis (BIVA) was evaluated by measuring phase angle (°) at baseline (0 minutes) and after 180 minutes from glucagon/placebo administration.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05206149


Locations
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Italy
AOU Città della Salute e della Scienza
Torino, Piemonte, Italy, 10126
Sponsors and Collaborators
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Publications:

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Responsible Party: Ezio Ghigo, Full Professor, Azienda Ospedaliera Città della Salute e della Scienza di Torino
ClinicalTrials.gov Identifier: NCT05206149    
Other Study ID Numbers: GST-intranasale
First Posted: January 25, 2022    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases