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

Primary Purpose

Hypopituitarism

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Intranasal glugagon
Intranasal placebo
Sponsored by
Azienda Ospedaliera Città della Salute e della Scienza di Torino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypopituitarism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • AOU Città della Salute e della Scienza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intranasal Administration of Glucagon

Intranasal Administration of Placebo

Arm Description

Intranasal administration of glucagon in healthy subjects

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

Outcomes

Primary Outcome Measures

Change in serum ACTH levels between baseline and 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.
Change in serum ACTH levels between baseline and 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.
Change in serum ACTH levels between baseline and 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.
Change in serum ACTH levels between baseline and 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.
Change in serum ACTH levels between baseline and 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.
Change in serum ACTH levels between baseline and 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.
Change in serum ACTH levels between baseline and 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.
Change in serum ACTH levels between baseline and 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.
Change in serum ACTH levels between baseline and 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.
Change in serum cortisol levels between baseline and 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.
Change in serum cortisol levels between baseline and 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.
Change in serum cortisol levels between baseline and 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.
Change in serum cortisol levels between baseline and 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.
Change in serum cortisol levels between baseline and 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.
Change in serum cortisol levels between baseline and 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.
Change in serum cortisol levels between baseline and 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.
Change in serum cortisol levels between baseline and 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.
Change in serum cortisol levels between baseline and 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.
Change in serum GH levels between baseline and 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.
Change in serum GH levels between baseline and 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.
Change in serum GH levels between baseline and 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.
Change in serum GH levels between baseline and 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.
Change in serum GH levels between baseline and 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.
Change in serum GH levels between baseline and 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.
Change in serum GH levels between baseline and 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.
Change in serum GH levels between baseline and 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.
Change in serum GH levels between baseline and 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.
Change in plasma copeptin levels between baseline and 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.
Change in plasma copeptin levels between baseline and 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.
Change in plasma copeptin levels between baseline and 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.
Change in plasma copeptin levels between baseline and 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.
Change in plasma copeptin levels between baseline and 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.
Change in plasma copeptin levels between baseline and 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.
Change in plasma copeptin levels between baseline and 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.
Change in plasma copeptin levels between baseline and 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.
Change in plasma copeptin levels between baseline and 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

Change in serum sodium levels between baseline and 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.
Change in serum sodium levels between baseline and 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.
Change in serum sodium levels between baseline and 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.
Change in serum sodium levels between baseline and 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.
Change in serum sodium levels between baseline and 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.
Change in serum sodium levels between baseline and 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.
Change in serum sodium levels between baseline and 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.
Change in serum sodium levels between baseline and 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.
Change in serum sodium levels between baseline and 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.
Change in serum potassium levels between baseline and 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.
Change in serum potassium levels between baseline and 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.
Change in serum potassium levels between baseline and 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.
Change in serum potassium levels between baseline and 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.
Change in serum potassium levels between baseline and 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.
Change in serum potassium levels between baseline and 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.
Change in serum potassium levels between baseline and 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.
Change in serum potassium levels between baseline and 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.
Change in serum potassium levels between baseline and 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.
Change in plasma osmolality between baseline and 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.
Change in plasma osmolality between baseline and 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.
Change in plasma osmolality between baseline and 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.
Change in plasma osmolality between baseline and 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.
Change in plasma osmolality between baseline and 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.
Change in plasma osmolality between baseline and 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.
Change in plasma osmolality between baseline and 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.
Change in plasma osmolality between baseline and 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.
Change in plasma osmolality between baseline and 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.
Change in serum glucose levels between baseline and 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.
Change in serum glucose levels between baseline and 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.
Change in serum glucose levels between baseline and 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.
Change in serum glucose levels between baseline and 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.
Change in serum glucose levels between baseline and 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.
Change in serum glucose levels between baseline and 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.
Change in serum glucose levels between baseline and 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.
Change in serum glucose levels between baseline and 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.
Change in serum glucose levels between baseline and 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.
Change in plasma insulin levels between baseline and 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.
Change in plasma insulin levels between baseline and 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.
Change in plasma insulin levels between baseline and 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.
Change in plasma insulin levels between baseline and 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.
Change in plasma insulin levels between baseline and 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.
Change in plasma insulin levels between baseline and 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.
Change in plasma insulin levels between baseline and 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.
Change in plasma insulin levels between baseline and 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.
Change in plasma insulin levels between baseline and 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.
Change in urine sodium levels between baseline and 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.
Change in urine potassium levels between baseline and 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.
Change in urine creatinine levels between baseline and 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.
Change in urine osmolality between baseline and 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.
Change in resistance at bioimpedance vector analysis between baseline and 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.
Change in reactance at bioimpedance vector analysis between baseline and 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.
Change in phase angle at bioimpedance vector analysis between baseline and 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.

Full Information

First Posted
December 1, 2021
Last Updated
January 11, 2022
Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino
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1. Study Identification

Unique Protocol Identification Number
NCT05206149
Brief Title
Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes
Official Title
Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypopituitarism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intranasal Administration of Glucagon
Arm Type
Experimental
Arm Description
Intranasal administration of glucagon in healthy subjects
Arm Title
Intranasal Administration of Placebo
Arm Type
Placebo Comparator
Arm Description
Intranasal administration of placebo (isotonic saline solution) in healthy subjects
Intervention Type
Drug
Intervention Name(s)
Intranasal glugagon
Other Intervention Name(s)
Baqsimi®
Intervention Description
Intranasal glucagon is administered at the dose of 3 mg. This corresponds to the administration of a single dose of Baqsimi®.
Intervention Type
Drug
Intervention Name(s)
Intranasal placebo
Intervention Description
Intranasal placebo (represented by isotonic saline solution) is administered.
Primary Outcome Measure Information:
Title
Change in serum ACTH levels between baseline and 15 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Title
Change in serum ACTH levels between baseline and 30 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Title
Change in serum ACTH levels between baseline and 45 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Title
Change in serum ACTH levels between baseline and 60 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Title
Change in serum ACTH levels between baseline and 75 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Title
Change in serum ACTH levels between baseline and 90 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Title
Change in serum ACTH levels between baseline and 120 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Title
Change in serum ACTH levels between baseline and 150 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Title
Change in serum ACTH levels between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Title
Change in serum cortisol levels between baseline and 15 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Title
Change in serum cortisol levels between baseline and 30 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Title
Change in serum cortisol levels between baseline and 45 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Title
Change in serum cortisol levels between baseline and 60 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Title
Change in serum cortisol levels between baseline and 75 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Title
Change in serum cortisol levels between baseline and 90 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Title
Change in serum cortisol levels between baseline and 120 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Title
Change in serum cortisol levels between baseline and 150 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Title
Change in serum cortisol levels between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Title
Change in serum GH levels between baseline and 15 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Title
Change in serum GH levels between baseline and 30 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Title
Change in serum GH levels between baseline and 45 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Title
Change in serum GH levels between baseline and 60 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Title
Change in serum GH levels between baseline and 75 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Title
Change in serum GH levels between baseline and 90 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Title
Change in serum GH levels between baseline and 120 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Title
Change in serum GH levels between baseline and 150 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Title
Change in serum GH levels between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Title
Change in plasma copeptin levels between baseline and 15 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Title
Change in plasma copeptin levels between baseline and 30 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Title
Change in plasma copeptin levels between baseline and 45 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Title
Change in plasma copeptin levels between baseline and 60 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Title
Change in plasma copeptin levels between baseline and 75 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Title
Change in plasma copeptin levels between baseline and 90 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Title
Change in plasma copeptin levels between baseline and 120 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Title
Change in plasma copeptin levels between baseline and 150 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Title
Change in plasma copeptin levels between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Secondary Outcome Measure Information:
Title
Change in serum sodium levels between baseline and 15 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Title
Change in serum sodium levels between baseline and 30 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Title
Change in serum sodium levels between baseline and 45 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Title
Change in serum sodium levels between baseline and 60 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Title
Change in serum sodium levels between baseline and 75 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Title
Change in serum sodium levels between baseline and 90 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Title
Change in serum sodium levels between baseline and 120 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Title
Change in serum sodium levels between baseline and 150 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Title
Change in serum sodium levels between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Title
Change in serum potassium levels between baseline and 15 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Title
Change in serum potassium levels between baseline and 30 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Title
Change in serum potassium levels between baseline and 45 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Title
Change in serum potassium levels between baseline and 60 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Title
Change in serum potassium levels between baseline and 75 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Title
Change in serum potassium levels between baseline and 90 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Title
Change in serum potassium levels between baseline and 120 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Title
Change in serum potassium levels between baseline and 150 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Title
Change in serum potassium levels between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Title
Change in plasma osmolality between baseline and 15 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Title
Change in plasma osmolality between baseline and 30 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Title
Change in plasma osmolality between baseline and 45 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Title
Change in plasma osmolality between baseline and 60 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Title
Change in plasma osmolality between baseline and 75 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Title
Change in plasma osmolality between baseline and 90 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Title
Change in plasma osmolality between baseline and 120 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Title
Change in plasma osmolality between baseline and 150 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Title
Change in plasma osmolality between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Title
Change in serum glucose levels between baseline and 15 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Title
Change in serum glucose levels between baseline and 30 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Title
Change in serum glucose levels between baseline and 45 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Title
Change in serum glucose levels between baseline and 60 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Title
Change in serum glucose levels between baseline and 75 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Title
Change in serum glucose levels between baseline and 90 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Title
Change in serum glucose levels between baseline and 120 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Title
Change in serum glucose levels between baseline and 150 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Title
Change in serum glucose levels between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Title
Change in plasma insulin levels between baseline and 15 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 15 minutes after glucagon/placebo administration
Title
Change in plasma insulin levels between baseline and 30 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 30 minutes after glucagon/placebo administration
Title
Change in plasma insulin levels between baseline and 45 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 45 minutes after glucagon/placebo administration
Title
Change in plasma insulin levels between baseline and 60 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 60 minutes after glucagon/placebo administration
Title
Change in plasma insulin levels between baseline and 75 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 75 minutes after glucagon/placebo administration
Title
Change in plasma insulin levels between baseline and 90 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 90 minutes after glucagon/placebo administration
Title
Change in plasma insulin levels between baseline and 120 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 120 minutes after glucagon/placebo administration
Title
Change in plasma insulin levels between baseline and 150 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 150 minutes after glucagon/placebo administration
Title
Change in plasma insulin levels between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Title
Change in urine sodium levels between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Title
Change in urine potassium levels between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Title
Change in urine creatinine levels between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Title
Change in urine osmolality between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Title
Change in resistance at bioimpedance vector analysis between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Title
Change in reactance at bioimpedance vector analysis between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration
Title
Change in phase angle at bioimpedance vector analysis between baseline and 180 minutes after glucagon/placebo administration
Description
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.
Time Frame
From baseline (0 minutes) to 180 minutes after glucagon/placebo administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
AOU Città della Salute e della Scienza
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28646378
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
Dichtel LE, Yuen KC, Bredella MA, Gerweck AV, Russell BM, Riccio AD, Gurel MH, Sluss PM, Biller BM, Miller KK. Overweight/Obese adults with pituitary disorders require lower peak growth hormone cutoff values on glucagon stimulation testing to avoid overdiagnosis of growth hormone deficiency. J Clin Endocrinol Metab. 2014 Dec;99(12):4712-9. doi: 10.1210/jc.2014-2830.
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PubMed Identifier
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Citation
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Citation
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Guzman CB, Dulude H, Piche C, Rufiange M, Sadoune AA, Rampakakis E, Carballo D, Triest M, Zhang MX, Zhang S, Tafreshi M, Sicard E. Effects of common cold and concomitant administration of nasal decongestant on the pharmacokinetics and pharmacodynamics of nasal glucagon in otherwise healthy participants: A randomized clinical trial. Diabetes Obes Metab. 2018 Mar;20(3):646-653. doi: 10.1111/dom.13134. Epub 2017 Nov 19.
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Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes

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