The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin

What Was Tested

In this not phased trial, researchers set out to test Ghrelin for insulin resistance, prediabetes & type 2 diabetes.

This study will investigate the non-growth-hormone-dependent metabolic effects of the hormone Ghrelin in growth hormone deficient subjects by examining the insulin tolerance as well as signal proteins in fat and muscle biopsies.

It had four arms (groups): Ghrelin / Acipimox (active comparator), Ghrelin / placebo (active comparator), Placebo / Acipimox (active comparator) and Placebo / placebo (placebo comparator).

Ghrelin infusion and tablet acipimox.

Ghrelin infusion and placebo tablets.

Saline infusion and tablet Acipimox.

The registry classes the interventions as drug and other.

More on the Plan

Ghrelin is a relatively 'new' hormone that is produced in the stomach and to a lesser extend in the hypothalamus of the brain.

The actions of ghrelin are diverse and includes stimulation of the appetite center of the brain and the release of growth hormone.

These effects have the researchers confirmed in growth hormone deficient subjects on a stabile substitution treatment with growth hormone and hydrocortisone.

With these subjects the researchers can investigate the effects of ghrelin that are independent of growth hormone.

Who Took Part

8 planned participants were the target.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males with hypopituitarism in regard to growth hormone and ACTH in stabile treatment regime.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: abuse of alcohol; malign disease; medication other than that expected for hypopituitarism.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

The insulin resistance, prediabetes & type 2 diabetes participants were allocated by chance, so the Ghrelin group and the comparison group should start out alike.

In the crossover set-up each of the insulin resistance, prediabetes & type 2 diabetes participants took both Ghrelin and the comparison in turn, acting as their own control.

Blinding on both sides kept the insulin resistance, prediabetes & type 2 diabetes participants and researchers unaware of who received Ghrelin.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2012-06 with completion listed for 2014-10.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Effects of ghrelin during basal and hyperinsulinemic conditions (time frame: 5 hours investigation day). Effects of ghrelin during basal and hyperinsulinemic conditions (time frame: 5 hours investigation day). Effects of ghrelin during basal and hyperinsulinemic conditions (time frame: 5 hours investigation day).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Ghrelin in 8 people with insulin resistance, prediabetes & type 2 diabetes.

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, Insulin resistance, prediabetes & type 2 diabetes research.