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

What Was Tested

The trial (phase 4) is built around Glucagon.

The diagnosis of secondary hypoadrenalism and GH deficiency (GHD) often requires the performance of a dynamic test.

It had two arms (groups): Intranasal Administration of Glucagon (experimental) and Intranasal Administration of Placebo (placebo comparator).

Intranasal administration of glucagon in healthy subjects.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 10 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

The full record lists 0 inclusion and 3 exclusion criteria; among the exclusions: BMI \< 18.5 kg/m2 or \> 25 kg/m2; pregnancy or breastfeeding.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

The participants were allocated by chance, so the Glucagon group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Glucagon and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Glucagon, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-10-01 with completion listed for 2021-12-31.

It ran at 1 site in Italy.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: 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). 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). 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).

It also tracked 52 secondary outcomes, for example Change in serum sodium levels between baseline and 15 minutes after glucagon/placebo administration, Change in serum sodium levels between baseline and 30 minutes after glucagon/placebo administration, Change in serum sodium levels between baseline and 45 minutes after glucagon/placebo administration, Change in serum sodium levels between baseline and 60 minutes after glucagon/placebo administration, Change in serum sodium levels between baseline and 75 minutes after glucagon/placebo administration and Change in serum sodium levels between baseline and 90 minutes after glucagon/placebo administration.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glucagon in 10 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glucagon compound page, all human trials.