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

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05319301

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oxytocin Deficiency Hypopituitarism Hypothalamic Obesity Pituitary Dysfunction Central Diabetes Insipidus Social Isolation	Dietary Supplement: Melatonin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with hypopituitarism A single dose of melatonin administration	Dietary Supplement: Melatonin A single dose of melatonin (1.9 mg)
Active Comparator: Healthy controls A single dose of melatonin administration	Dietary Supplement: Melatonin A single dose of melatonin (1.9 mg)

Arm

Intervention/Treatment

Experimental: Patients with hypopituitarism

A single dose of melatonin administration

Dietary Supplement: Melatonin

A single dose of melatonin (1.9 mg)

Active Comparator: Healthy controls

A single dose of melatonin administration

Dietary Supplement: Melatonin

A single dose of melatonin (1.9 mg)

Outcome Measures

Primary Outcome Measures

Change in oxytocin concentration [Baseline blood exam (timepoint 0) and further blood collections after 30, 60, 90 and 120 minutes after baseline blood collection]
Change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin orally.

Secondary Outcome Measures

Maximal change in oxytocin concentration (pg/mL) [Within the two hours after the injection]
Maximal change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin administered orally.
Overall oxytocin secretion [Within the two hours after the injection]
Oxytocin area under the curve after administration of 1.9 melatonin administered orally
Mood assessment [At baseline]
Correlation between Beck Depression Inventory-2 score (range from 0 to 63, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)
Quality of life assessment [At baseline]
Correlation between 36 item- Short Form Health Survey score (range from 0 to 100, the higher scores indicate better health status) and baseline oxytocin concentration (pg/mL)
Impulsivity assessment [At baseline]
Correlation between Barratt Impulsiveness Scale (range from 30 to 120, higher scores indicate greater impulsivity) and baseline oxytocin concentration (pg/mL)
Alexithymia assessment [At baseline]
Correlation between Toronto Alexithymia scales-20 score (range from 20 to 100, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.