Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

What Was Tested

The trial (not phased) is built around Tesamorelin.

The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing Hormone (GHRH, tesamorelin) administration in healthy men.

It had 1 arm (groups): Growth Hormone Releasing Hormone (experimental).

The registry classes the interventions as drug.

More on the Plan

The primary objective of this study is to determine the effects of growth hormone releasing hormone (Tesamorelin) on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake.

At baseline and after two weeks of treatment, the researchers will assess overnight growth hormone by frequent sampling as well as insulin stimulated glucose uptake by clamp.

Subjects will then stop the Tesamorelin and will return for an identical assessment after a 2 week withdrawal period.

Who Took Part

15 actual participants took part.

It was open to men only aged from 18 years up to 60 years.

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

Examples of who could join: Men aged 18-60 years. BMI \> 20kg/m2 and \<35kg/m2.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: use of anti-diabetic agents, megace, testosterone or any steroid use within 6 months of the study; use of gh or growth hormone stimulating peptides within six months of starting the study; change in lipid lowering or antihypertensive regimen within 3 months of screening.

How the Study Was Run

Design: single-group and open-label.

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

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

It started in 2009-02 with completion listed for 2010-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Overnight Growth Hormone (time frame: at 2 weeks (i.e., after 2 weeks of treatment)).

It also tracked 1 secondary outcome, for example Insulin Stimulated Glucose Utilization.

What This Means in Plain Language

Put simply, this is a not phased trial of Tesamorelin in 15 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Tesamorelin compound page, all human trials.