Study of Glucagon, Ghrelin and Growth Hormone as Counterregulatory Hormones

What Was Tested

In this not phased trial, researchers set out to test Glucagon.

Glucagon has been used for decades as a test of growth hormone (GH) reserve.

The pathway by which GH is stimulated by glucagon is not established.

It had four arms (groups): Saline s.c. injection and placebo tablet (other), glucagon s.c. injection and placebo tablet (other), Saline s.c. injection and atenolol tablet (other) and glucagon s.c. injection and atenolol tablet (other).

Saline s.c. injection and one placebo tablet (preceded by one placebo tablet per day at 0900h for two days before admission).

The registry classes the interventions as drug.

More on the Plan

Ghrelin is a 28 amino acid peptide which is released from the fundus of the stomach, within the oxyntic glands and the small intestine.

It circulates in two major forms, acylated and des-acylated ghrelin.

Acylated ghrelin has strong GH-releasing effects which are mediated via the G-protein coupled ghrelin receptor.

Who Took Part

6 planned participants were the target.

It was open to men only aged from 18 years up to 30 years.

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

Examples of who could join: Healthy normal men. Age 18-30 yrs. BMI 18-27 kg/m2.

The full record lists 3 inclusion and 16 exclusion criteria; among the exclusions: medication or previous surgery known to affect ghrelin secretion; medications known to have an impact on body weight (seroquel, tricyclic antidepressants); medications known to have an impact on the beta adrenergic system.

How the Study Was Run

Design: randomized, crossover and single-blind.

Because people in this Glucagon study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Glucagon and the comparison at some point, usually with a gap in between.

Only one side, usually the participants, was kept unaware of whether Glucagon was given.

Those kept unaware of assignments: participant.

It started in 2012-12 with completion listed for 2014-07.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Circulating acyl-ghrelin concentration after glucagon stimulation with and without beta-adrenergic blockade (time frame: 18 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 6 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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