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

NCT04897802 · Completed

Last updated 2026-05-28

This clinical trial is testing whether people with conditions like hypopituitarism or pituitary diseases have low oxytocin levels and how this might relate to their health.

Status Completed The study has finished.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, single-blind diagnostic study

Participants 42 people

Who can join Ages 18–65 · all sexes Healthy volunteers accepted.

Timeline Started 2021-09 · est. completion 2024-12

Where 1 site · Spain

What this study is testing ClinicalTrials.gov NCT04897802 ↗

Description as written by the study sponsor.

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. Hypopituitarism is associated with increased obesity, increased psychopathology, sexual and prosocial dysfunction despite appropriate hormone replacement. A few studies suggest the existence of a possible OT deficient state in hypopituitarism. In animal models, glucagon-like peptide 1 (GLP1) has shown to increase OT release. This study is designed to evaluate OT values after administration of GLP1 in adults (healthy volunteers and patients with hypopituitarism). The investigators hypothesize that OT response will be blunted following GLP1 receptor agonist (GLP1-RA) in patients with hypopituitarism compared to healthy controls.

Treatments tested

Experimental: GLP1-RA (exenatide) administration also known as exenatide administration Drug

a single dose of 10 mcg of GLP-RA (exenatide) will be administered subcutaneously and samples to assess OT secretory patterns will be collected over 2 hours
Control: Placebo administration also known as placebo administration (sodium chloride) Drug

Sodium Chloride 0.9% will be administered subcutaneously at equivalent volume than 10 mcg of exenatide

Main thing measured	Change in oxytocin concentration (pg/mL)
Sponsor	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions studied	Hypopituitarism, Central Diabetes Insipidus, Panhypopituitarism, Psychological Disorder, Social Isolation, Hypothalamic Diseases, Pituitary Diseases, Oxytocin Deficiency
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04897802 ↗