Pharmacokinetics of Ghrelin

What Was Tested

This registered not phased trial tested Ghrelin.

The main purpose of this study is to determine the half life of the hormone "ghrelin" in the human body.

Other purposes are to investigate the effect of ghrelin on appetite and cardiovascular function.

The registry classes the interventions as drug.

More on the Plan

Ghrelin is a recently described acylated peptide hormone produced by the enteroendocrine cells of the mucosal epithelial layer in the ventricle.

Ghrelin is the endogenous ligand for the growth hormone (GH) secretagogue receptor (GHS-R).

Ghrelin stimulates pituitary GH release by binding to the GHS-R at both hypothalamic and pituitary levels.

Several studies show that bolus injections of ghrelin have positive effects on cardiac function in healthy humans as well as in humans with cardiac disease.

Who Took Part

Enrollment: 17 planned participants were the target.

It was open to men only aged from 18 years up to 40 years.

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

Examples of who could join: BMI \< 25 kg/m2. Age \< 40 yrs.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: any known disease; any medication (except otcs); former malignant disease.

How the Study Was Run

Design: randomized, crossover and double-blind.

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

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

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

It started in 2005-03 with completion listed for 2006-01.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Human ghrelin half life in healthy subjects.

It also tracked 1 secondary outcome, for example Cardiovascular indices (stroke-velocity index, TEI-index).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Ghrelin in 17 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 Ghrelin compound page, all human trials.