Glucagon Modulation of Ghrelin Secretion

What Was Tested

In this phase 3 trial, researchers set out to test Glucagon.

As a counterregulatory hormone for insulin, glucagon plays a critical role in maintaining glucose homeostasis in vivo.

It is well known that intramuscular glucagon administration stimulates growth hormone (GH), adrenocorticotropic hormone (ACTH) and cortisol release in humans.

It had two arms (groups): Glucagon hydrochloride (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 38 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Subjects \> 18 and \< 60 years old. Patients with diabetes type 1 should fulfill the following criteria:. ICT Insulin therapy was necessary within the first 3 months after diagnosis;.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: diabetes type 1 or 2 (for the healthy group); biochemical evidence of impaired hepatic or renal function; history of cardiovascular disease.

How the Study Was Run

Design: randomized, crossover and triple-blind.

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

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

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 and investigator.

It started in 2006-06 with completion listed for 2008-01.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Changes in satiety scale, total and acylated ghrelin concentrations (time frame: During 240 min after Glucagon/Placebo administration).

It also tracked 1 secondary outcome, for example Changes in glucose, insulin and NEFA concentrations.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glucagon in 38 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.