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

Primary Purpose

Oxytocin Deficiency, Hypopituitarism, Hypothalamic Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Melatonin
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Oxytocin Deficiency focused on measuring oxytocin, melatonin, hypopituitarism, vasopresin deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with hypopituitarism

Healthy controls

Arm Description

A single dose of melatonin administration

A single dose of melatonin administration

Outcomes

Primary Outcome Measures

Change in oxytocin concentration
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)
Maximal change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin administered orally.
Overall oxytocin secretion
Oxytocin area under the curve after administration of 1.9 melatonin administered orally
Mood assessment
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
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
Correlation between Barratt Impulsiveness Scale (range from 30 to 120, higher scores indicate greater impulsivity) and baseline oxytocin concentration (pg/mL)
Alexithymia assessment
Correlation between Toronto Alexithymia scales-20 score (range from 20 to 100, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)

Full Information

First Posted
March 17, 2022
Last Updated
March 31, 2022
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT05319301
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxytocin Deficiency, Hypopituitarism, Hypothalamic Obesity, Pituitary Dysfunction, Central Diabetes Insipidus, Social Isolation
Keywords
oxytocin, melatonin, hypopituitarism, vasopresin deficiency

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with hypopituitarism
Arm Type
Experimental
Arm Description
A single dose of melatonin administration
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
A single dose of melatonin administration
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
A single dose of melatonin (1.9 mg)
Primary Outcome Measure Information:
Title
Change in oxytocin concentration
Description
Change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin orally.
Time Frame
Baseline blood exam (timepoint 0) and further blood collections after 30, 60, 90 and 120 minutes after baseline blood collection
Secondary Outcome Measure Information:
Title
Maximal change in oxytocin concentration (pg/mL)
Description
Maximal change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin administered orally.
Time Frame
Within the two hours after the injection
Title
Overall oxytocin secretion
Description
Oxytocin area under the curve after administration of 1.9 melatonin administered orally
Time Frame
Within the two hours after the injection
Title
Mood assessment
Description
Correlation between Beck Depression Inventory-2 score (range from 0 to 63, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)
Time Frame
At baseline
Title
Quality of life assessment
Description
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)
Time Frame
At baseline
Title
Impulsivity assessment
Description
Correlation between Barratt Impulsiveness Scale (range from 30 to 120, higher scores indicate greater impulsivity) and baseline oxytocin concentration (pg/mL)
Time Frame
At baseline
Title
Alexithymia assessment
Description
Correlation between Toronto Alexithymia scales-20 score (range from 20 to 100, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Aulinas, MD PhD
Phone
+34932919000
Ext
7917
Email
aaulinas@santpau.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Delgado
Phone
+34932919000
Ext
7634
Email
cdelgadoe@santpau.cat
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain

12. IPD Sharing Statement

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

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