Diagnosing Adult Growth Hormone Deficiency

What Was Tested

The trial (not phased) is built around GHRH (Growth Hormone-Releasing Hormone).

The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against the IS 98/574 from the World Health Organization.

A specific aim was to study the effect of gender and age on the peak GH response in the GHRH+arg test.

It had two arms (groups): healthy control subjects (other) and patients with suspected GH deficiency (experimental).

126 healthy controls underwent the GHRH plus arginine stimulations test.

34 patients with pituitary disease and suspicion of GH deficiency underwent the GHRH plus arginine test.

The registry classes the interventions as other.

More on the Plan

These signs are nonspecific, and accurate diagnosis with laboratory tests in needed.

The GHRH+arg test is used to diagnose AGHD, but the cut-off values vary based on controls used.

At moment consensus cut-off criteria are BMI specific, but gender and age may also affect the GH response in the GHRH+arg.

Who Took Part

The registry lists 160 actual participants took part.

It was open to people of any sex aged from 16 years up to 80 years.

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

Examples of who could join: Age 20-60 years,. No symptoms indicative of disease. Age 16-90 years. Previous pituitary disease. Suspicion of growth hormone deficiency.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: a known or suspected disease,; any symptoms indicating disease; use of medication.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

The GHRH (Growth Hormone-Releasing Hormone) group and the comparison group ran side by side rather than switching.

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 2001-05 with completion listed for 2008-12.

It ran at 1 site in Finland.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Peak serum GH (ug/l) by Immulite 2000 Xpi (time frame: one year).

It also tracked 2 secondary outcomes, for example Serum insulin like growth hormone 1 (IGF-1) concentration and Basal serum GH (ug/l) by Immulite 2000 Xpi.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of GHRH (Growth Hormone-Releasing Hormone) in 160 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.