Ghrelin Decreases Insulin Sensitivity

What Was Tested

This registered phase 1 trial tested Ghrelin.

The aim of this study is to investigate the effect of short term ghrelin administration to humans on metabolism.

It had 1 arm (groups): 2 (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The current study is initiated in order to assess the impact of acute ghrelin administration on insulin resistance measured by a hyperinsulinemic euglycemic clamp.

Second, as free fatty acid is the predominant substrate during fasting, the researchers aim to asses the effects of ghrelin on local and systemic lipolysis.

Who Took Part

The registry lists 8 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

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

Examples of who could join: Healthy men, age \>= 18 yr age \< 50 yr, body mass index \< 27.5 kg/m2above or equal to 18 yr.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: any disease, use of prescribed medication, age \< 18 yr or \>= 50 yr.

How the Study Was Run

The set-up was randomized, crossover and single-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.

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

Those kept unaware of assignments: participant.

It started in 2003-01 with completion listed for 2003-10.

Its stated primary purpose is health services research.

What Was Measured

Researchers chose this as the main measure: Insulin sensitivity (time frame: End of clamp period).

It also tracked 1 secondary outcome, for example Effects on lipolysis.

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.