Effect of Ghrelin on Sympathetic Nervous System

What Was Tested

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

Ghrelin is a newly discovered peptide that is secreted by the stomach.

The registry classes the interventions as drug.

More on the Plan

Blood samples will be taken at regular intervals for various metabolic tests.

These responses will be compared to those when submitted to saline infusion.

Who Took Part

The registry lists 46 planned participants were the target.

It was open to men only aged from 18 years up to 65 years.

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

Examples of who could join: Healthy lean subjects with a BMI \< 25 kg/m2 and subjects with central obesity (according to IDF definition).

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: any current medication; cardiovascular, cerebrovascular, liver, thyroid disease; mental illness.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

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

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

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

Those kept unaware of assignments: participant.

It started in 2009-06 with completion listed for 2010-05.

It ran at 1 site in Australia.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Sympathetic nervous activity (time frame: 60 min).

It also tracked 1 secondary outcome, for example blood pressure.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Ghrelin in 46 people.

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.