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

NCT05319301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-09

No results posted yet for this study

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, melatonin has shown to increase OT release.

This study is designed to evaluate oxytocin values after administration of melatonin in adults (healthy volunteers and patients with hypopituitarism).

The investigators hypothesize that OT response will be blunted following melatonin in patients with hypopituitarism compared to healthy controls.

Conditions

  • Oxytocin Deficiency
  • Hypopituitarism
  • Hypothalamic Obesity
  • Pituitary Dysfunction
  • Central Diabetes Insipidus
  • Social Isolation

Interventions

DIETARY_SUPPLEMENT

Melatonin

A single dose of melatonin (1.9 mg)

Sponsors & Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2023-09-01
Completion
2023-11-01

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05319301 on ClinicalTrials.gov