The Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and Adrenocorticotropic Axis

What Was Tested

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

The purpose of this study is to find out if the Glucagon Stimulation Test (GST) is a reliable alternative to the Insulin Tolerance Test (ITT) for diagnosis of Growth Hormone Deficiency (GHD) and adrenal insufficiency.

In some patients the accuracy of the GST for evaluation of adrenal insufficiency is compared to the adrenocorticotropin hormone (ACTH ) stimulation test.

It had two arms (groups): Study patients (experimental) and Control (active comparator).

The registry classes the interventions as procedure.

More on the Plan

Growth hormone is a protein that is produced by the pituitary gland and influences the metabolism (how fast things work) of other proteins, carbohydrates, and fats in the body.

Some people have what is called Growth Hormone Deficiency (GHD), which means that they do not produce enough growth hormone.

GHD is usually evaluated through growth hormone stimulation test(s).

One of the most reliable tests to evaluate if someone has GHD is by using arginine + Growth Hormone Releasing Hormone (GHRH) test.

Who Took Part

The registry lists 43 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: 18 to 80 years of age. Male and female. Hypothalamic pituitary disorders (study subjects). History of regular, age appropriate menses (control subjects). Male subjects with normal serum testosterone and follicle stimulating hormone (FSH) (control subjects).

The full record lists 7 inclusion and 17 exclusion criteria; among the exclusions: unable to give consent; active acromegaly; active cushing's disease.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Glucagon and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Glucagon study: the participants and staff both knew the treatment.

It started in 2011-01 with completion listed for 2014-07.

It ran at 4 sites in United States (4).

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD) (time frame: one year). Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD) (time frame: one year). Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD) (time frame: one year).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 43 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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