Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing

What Was Tested

This registered not phased trial tested GHRH (Growth Hormone-Releasing Hormone).

Specific Aim 1 Healthy male and female subjects and growth hormone (GH) deficient subjects display sexually dimorphic GH responses to GHRH administration Specific Aim 2 GH responses to GHRH in both healthy controls and in GH deficient patients correlate with expression and activity of the stimulatory G proteins, G alpha q and G alpha S.

G protein levels correlate with gonadal steroid levels.

Specific Aim 3 Sexually dimorphic GH responses to GHRH are enhanced in Tanner Stage V compared to Tanner Stage 1 individuals.

The registry classes the interventions as procedure.

More on the Plan

Growth hormone deficiency affects disproportionately more males than females.

Although ascertainment bias plays a role in this sexual dimorphism, no plausible mechanism to fully explain this difference has been proposed.

This investigator initiated study will provide currently unavailable data on sexual/age differences in response to GH stimulation testing.

Data obtained from the study may provide a basis for developing appropriate normal ranges for adult GH testing, may provide a plausible mechanism for the enhanced hormone responsiveness observed in females, and may provide data on when the sexual differences to GH stimulation may develop.

Who Took Part

Enrollment: 90 planned participants were the target.

It was open to people of any sex aged from 5 years up to 40 years.

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

Examples of who could join: Males and females, Tanner stage V aged 15-40 years of age with no known endocrine problems. Males and females, Tanner stage I, aged 5-8 years with no known endocrine problems.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: history of gh deficiency or treatment or other known endocrine disorder; current height or adult height \<5th %; female subjects using hormonal methods of birth control.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Being open-label, the GHRH (Growth Hormone-Releasing Hormone) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2007-07 with completion listed for 2009-07.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Serum GH levels in response to GHRH/arginine stimulation (time frame: End of study).

It also tracked 2 secondary outcomes, for example mRNA and protein levels of G alpha q and G alpha S stimulatory proteins and Serum gonadal steroid levels in the three subject groups.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of GHRH (Growth Hormone-Releasing Hormone) in 90 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.