Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study)

What Was Tested

The trial (phase 4) is built around Exenatide.

Oxytocin (OT) is a hypothalamic peptide that enters the peripheral circulation via the posterior pituitary gland.

OT plays a key role in regulating appetite, psychopathology, prosocial behavior and sexual function.

It had two arms (groups): Experimental: GLP1-RA administration (experimental) and Control: Placebo administration (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

This research is focused on two groups of participants: healthy controls (HC) and hypopituitary patients (HYPO) with at least one symptom of hypothalamic damage, presumably at highest risk for OT deficiency.

Clinical implications of secretory OT dynamics and release under different stimuli using validated questionnaires to evaluate psychopathology, socio-emotional functioning, disordered eating behavior, impaired quality of life and sexual dysfunction, will be also evaluated.

Who Took Part

The registry lists 42 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Patients with hypopituitarism (HYPO) (\>1 pituitary hormone deficiency) and stable hormone replacement for the prior three months. At least one clinical sign of hypothalamic damage. Female participants will be done in the early to midfollicular phase.

The full record lists 3 inclusion and 16 exclusion criteria; among the exclusions: uncorrected hormone deficiency; alanine aminotransferase (alt) or aspartate amino transferase (ast) \>2.5x upper limit of normal; suicidality or active psychosis.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Exenatide and the comparison in turn, acting as their own control.

Only one side, usually the participants, was kept unaware of whether Exenatide was given.

Those kept unaware of assignments: participant.

It started in 2021-09-13 with completion listed for 2024-04-30.

It ran at 1 site in Spain.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Change in oxytocin concentration (pg/mL).

It also tracked 8 secondary outcomes, for example Maximal change in oxytocin concentration (pg/mL), Overall oxytocin secretion (pg/mL), Change in glucose concentration (mg/dL), Change in insulin concentration (pmol/L), Mood assessment and Quality of life assessment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 42 people.

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

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