Local Metabolic Effects of Ghrelin in Skeletal Muscle and Adipose Tissue

What Was Tested

The trial (early phase 1) is built around Ghrelin.

The metabolic effects of ghrelin is investigated by microdialysis technique.

Subjects are healthy young men.

End points are interstitial concentrations of glucose, lactate, and glycerol.

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

Ghrelin.

Ringer acetate is used for placebo.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 10 actual participants took part.

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: Age 18-65 years (included). Body mass index 20-25 (included).

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: alcohol abuse; malignant disease; use of any medicine except otc painkillers.

How the Study Was Run

Design: randomized, crossover and single-blind.

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.

In the crossover set-up each of the participants took both Ghrelin and the comparison in turn, acting as their own control.

In this single-blind Ghrelin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2012-06 with completion listed for 2012-09.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Interstitial concentrations of glycerol (time frame: Interstitial concentrations of glycerol at t=120 minutes).

It also tracked 2 secondary outcomes, for example Interstitial concentrations of lactate and Interstitial concentrations of glucose.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Ghrelin in 10 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.