Identification and Clinical Relevance of an Oxytocin Deficient State: a Randomized, Crossover, Placebo-controlled, Proof-of-concept, Physiopathological Study (GLP1 Study)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Contact Information
Primary
Anna Aulinas, MD PhD
aaulinas@santpau.cat
+34 932919000
Time Frame
Start Date: 2021-09-13
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 52
Treatments
Experimental: Experimental: GLP1-RA administration
A single dose of 10 mcg of GLP1-RA (exenatide) will be injected subcutaneously and samples will be collected over 2 hours (15 (T15), 30 (T30), 45 (T45), 60 (T60'), 90 (T90) and 120 (T120) minutes) after GLP1-RA:placebo administration to assess OT secretory patterns
Placebo_comparator: Control: Placebo administration
Sodium Chloride 0.9% will be administered subcutaneously at equivalent volume than GLP1-RA (exenatide) administration
Sponsors
Leads: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators: Instituto de Salud Carlos III

This content was sourced from clinicaltrials.gov