Peripheral Metabolic Effects of Ghrelin

What Was Tested

The trial (phase 1) is built around Ghrelin.

The aim of this study is to investigate putative peripheral effects of ghrelin on glucose and lipid metabolism in healthy men.

Eight subjects will be enrolled.

The hypothesis is that ghrelin infusion causes insulin resistance and lipolysis.

It had 1 arm (groups): Ghrelin (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 8 planned participants were the target.

It was open to men only aged from 18 years up to 60 years.

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

Examples of who could join: BMI \< 27 kg/m2. Written informed consent.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: any disease including epilepsy; any use of medications (excl. paracetamol); present or previous malignancy.

How the Study Was Run

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

Because people in this Ghrelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant.

It started in 2008-10 with completion listed for 2009-01.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Plasma levels of glucose (time frame: During study day).

It also tracked 2 secondary outcomes, for example Insulin signaling and Serum levels of fatty acids.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Ghrelin in 8 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.