Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients

What Was Tested

The trial (not phased) is built around Ghrelin.

In growth hormone deficient patients: Determination of endogenous circulating ghrelin levels, ghrelin effects on insulin sensitivity, appetite, energy metabolism, and signal transduction in fat and muscle.

The registry classes the interventions as drug.

Who Took Part

8 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Age between 18 and 60 yrs. Unchanged substitution treatment through 3+ months. Unchanged additional medical treatment. Oral and written informed consent.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: age below 18 or above 60 yrs; diabetes mellitus; body mass index \> 30.

How the Study Was Run

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

As a double-blind Ghrelin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2005-10 with completion listed for 2007-03.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Endogenous serum ghrelin levels (time frame: Same day as intervention).

It also tracked 1 secondary outcome, for example Insulin sensitivity, appetite, metabolism, intracellular signal transduction.

What This Means in Plain Language

Put simply, this is a not phased, 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.