Clinical trial NCT05319301: Identification and Clinical Relevance of an Oxytocin Deficient State (Melatonin Study)
Official title: Identification and Clinical Relevance of an Oxytocin Deficient State Following Melatonin Administration in Patients With Hypopituitarism: a Proof-of-concept, Physiopathological Study With a Control Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxytocin Deficiency
Hypopituitarism
Hypothalamic Obesity
Pituitary Dysfunction
Central Diabetes Insipidus
Social Isolation
Keywords: oxytocin
melatonin
hypopituitarism
vasopresin deficiency
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* uncorrected hormone deficiency
* creatinine \>1.5mg/dL
* alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5x upper limit of normal
* hematocrit less than 30%
* suicidality or active psychosis
* participation in a trial with investigational drugs within 30 days
* using a high glucocorticoid dose
* vigorous physical exercise
* alcohol intake within 24 hours before the study participation
* evidence of any acute illness or any illness that the Investigator determines could interfere with study participation or safety
* pregnancy or breastfeeding for last 8 weeks
* known allergies towards melatonin
* patients refusing or unable to give written informed consent
* patients receiving fluvoxamine and/or impossibility to stop hypnotics 48 hours prior to the study visit.
* Additionally for healthy controls: the presence of brain or pituitary tumor, radiation involving the hypothalamus or pituitary, history of hypopituitarism or receiving testosterone or glucocorticoids esters.

Primary outcomes:
measure: Change in oxytocin concentration
timeFrame: Baseline blood exam (timepoint 0) and further blood collections after 30, 60, 90 and 120 minutes after baseline blood collection
Secondary outcomes:
measure: Maximal change in oxytocin concentration (pg/mL)
timeFrame: Within the two hours after the injection
measure: Overall oxytocin secretion
timeFrame: Within the two hours after the injection
measure: Mood assessment
timeFrame: At baseline
measure: Quality of life assessment
timeFrame: At baseline
measure: Impulsivity assessment
timeFrame: At baseline
measure: Alexithymia assessment
timeFrame: At baseline
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References: