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

NCT05319301 | Completed

• 1 other identifier: IIBSP-OXI-2021-112
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

oxytocin; melatonin; hypopituitarism; vasopresin deficiency

Outcome Measures

Primary Outcomes (1)

• Change in oxytocin concentration

  Change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin orally.

  Baseline blood exam (timepoint 0) and further blood collections after 30, 60, 90 and 120 minutes after baseline blood collection

Secondary Outcomes (6)

• Maximal change in oxytocin concentration (pg/mL)

  Within the two hours after the injection

• Overall oxytocin secretion

  Within the two hours after the injection

• Mood assessment

  At baseline

• Quality of life assessment

  At baseline

• Impulsivity assessment

  At baseline

Study Arms (2)

Patients with hypopituitarism

EXPERIMENTAL

A single dose of melatonin administration

Dietary Supplement: Melatonin

Healthy controls

ACTIVE COMPARATOR

A single dose of melatonin administration

Dietary Supplement: Melatonin

Interventions

Melatonin DIETARY_SUPPLEMENT

A single dose of melatonin (1.9 mg)

Healthy controls; Patients with hypopituitarism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

MeSH Terms

Conditions

Hypopituitarism; Sexual Infantilism; Diabetes Insipidus, Neurogenic; Social Isolation

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Hypogonadism; Diabetes Insipidus; Kidney Diseases; Urologic Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 8, 2022
• Study Start: April 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 9, 2024

Record last verified: 2023-03

Locations

ES (1)