Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone Deficiency

What Was Tested

This registered not phased trial tested Insulin (regular human).

Study aims: Diagnosing GH and cortisol deficiency in adults requires a special test.

At present, the insulin tolerance test (ITT) is considered the test of choice.

It had two arms (groups): Pegvisomant-glucagon test (active comparator) and Insulin tolerance test (active comparator).

To compare the combined pegvisomant with the glucagon test to the insulin tolerance test and the glucagon test in diagnosing adult growth hormone and cortisol insufficiency.

To compare the combined pegvisomant with the glucagon test to the insulin tolerance test and the glucagon test in diagnosing adult growth hormone and cortisol insufficiency.

The registry classes the interventions as drug.

More on the Plan

Background: The diagnosis of GH deficiency in adults is established by provocative testing of GH secretion.

The insulin tolerance test (ITT) is widely regarded as the gold standard test for diagnosing adult GH deficiency despite concerns about its practicality, safety, reproducibility, and its contraindications in elderly adults, adults with seizures and patients with ischemic heart disease.

The glucagon stimulation test (GST) has been proposed as the alternative to the ITT for the following reasons: 1) availability; 2) low cost and 3) safety.

This test has been validated in the past as a reliable test in assessing the GH reserve in both adults and children.

Who Took Part

10 planned participants were the target.

It was open to people of any sex aged from 21 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ability to provide written informed consent and comply with study assessments for the full duration of the study. Age 21 to 55 years. Body weight 60 to 120 kg inclusive. Stable weight and diet for at least 3 months prior to study entry.

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: poor iv access; known hypersensitivity to glucagon; inability or unwillingness to comply with study procedures.

How the Study Was Run

Design: randomized, crossover and open-label.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2011-03 with completion listed for 2013-11.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Peak growth hormone and cortisol levels induced by the pegvisomant-glucagon test compared to those by the insulin tolerance test in assessing the growth hormone and cortisol reserve in adults suspected of adult growth hormone and cortisol deficiencies (time frame: 9 weeks).

It also tracked 1 secondary outcome, for example Correlation of peak GH and cortisol levels to BMI and fasting glucose, and effects of pegvisomant on IGF-I bioactivity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 10 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 Insulin (regular human) compound page, all human trials.