Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency

What Was Tested

In this phase 3 trial, researchers set out to test GHRH (Growth Hormone-Releasing Hormone).

The aim of the study is to determine the specificity and sensitivity of the combined growth hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly probable adult growth hormone deficiency (AGHD) and subjects who were probably free of AGHD.

It had two arms (groups): Group 1: (active comparator) and Group 2: (active comparator).

The registry classes the interventions as other.

More on the Plan

The randomisation was carried out before the first test was performed.

In order to be informed of the subject's randomisation group, the investigator phoned the access number given to him/her.

The subject's allocation to a given randomisation arm was determined on the basis of a centralised randomisation (answering service), balanced per group of subjects with a minimisation on 2 criteria: age and BMI.

In each of these 3 categories, the subjects underwent 3 tests whose sequences were determined by the following randomisation group: * Group 1: GHRH+Arg, GHRH+Arg, ITT or * Group 2: ITT, ITT, GHRH+Arg.

Who Took Part

69 actual participants took part.

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

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

Examples of who could join: Subjects aged over 18 years and under 60 years,. Female or male,. Subjects not treated by GH or having stopped the treatment more than 15 days ago,. Signed informed consent,. Subjects possessing social security cover.

The full record lists 15 inclusion and 16 exclusion criteria; among the exclusions: subjects presenting a coronary history or whose electrocardiographic signs evoke an ischemic pathology,; subjects presenting a history of cerebrovascular insufficiency,; subjects presenting a history of epilepsy,.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this GHRH (Growth Hormone-Releasing Hormone) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when GHRH (Growth Hormone-Releasing Hormone) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2004-01 with completion listed for 2005-11.

It ran at 1 site in France.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Level of GH peak (recorded following stimulation tests).

It also tracked 1 secondary outcome, for example It was asked to the patients to evaluate acceptability of each test via a visual analogic scale.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of GHRH (Growth Hormone-Releasing Hormone) in 69 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the GHRH (Growth Hormone-Releasing Hormone) compound page, all human trials.