Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study)

NCTNCT04897802Other idIIBSP-OXI-2020-102

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 42 participants (actual)
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Other
Design: Randomized · Single masking
Countries: 1 country
Spain
Start: 13 Sept 2021
Primary completion: 30 Apr 2024
Completion: 31 Dec 2024
First posted: 24 May 2021
Last update posted: 20 Jan 2026
Conditions: Hypopituitarism · Central Diabetes Insipidus · Panhypopituitarism · Psychological Disorder · Social Isolation · Hypothalamic Diseases · Pituitary Diseases · Oxytocin Deficiency

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20212022202320242025

Ph 4
Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study)
NCT04897802
13 Sept 2021 to 31 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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, glucagon-like peptide 1 (GLP1) has shown to increase OT release. This study is designed to evaluate OT values after administration of GLP1 in adults (healthy volunteers and patients with hypopituitarism). The investigators hypothesize that OT response will be blunted following GLP1 receptor agonist (GLP1-RA) in patients with hypopituitarism compared to healthy controls.

Interventions

Experimental: GLP1-RA (exenatide) administrationDrug
Control: Placebo administrationDrug

Arms2

Experimental
Experimental: GLP1-RA administration
A single dose of 10 mcg of GLP1-RA (exenatide) will be injected subcutaneously and samples will be collected over 2 hours (15 (T15), 30 (T30), 45 (T45), 60 (T60'), 90 (T90) and 120 (T120) minutes) after GLP1-RA:placebo administration to assess OT secretory patterns
Placebo comparator
Control: Placebo administration
Sodium Chloride 0.9% will be administered subcutaneously at equivalent volume than GLP1-RA (exenatide) administration

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in oxytocin concentration (pg/mL)
Time frame · Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection
Registry description
Change in oxytocin concentration (pg/mL) after administration of 10 µg of GLP1-RA (exenatide) or 0.9% sodium chloride (NaCl)

Secondary outcomes(8)

Maximal change in oxytocin concentration (pg/mL)
Time frame · Within the two hours after the injection
Registry description
Change in oxytocin concentration (pg/mL) after administration of 10 µg of GLP1-RA (exenatide) or 0.9% NaCl
Overall oxytocin secretion (pg/mL)
Time frame · Within the two hours after the injection
Registry description
Oxytocin area under the curve after administration of 10 µg of GLP1-RA (exenatide) or 0.9% NaCl
Change in glucose concentration (mg/dL)
Time frame · Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection
Registry description
Change in glucose concentration (mg/dL) after administration of 10 µg of GLP1-RA (exenatide) or 0.9% NaCl
Change in insulin concentration (pmol/L)
Time frame · Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection
Registry description
Change in insulin concentration (pmol/L) after administration of 10 µg of GLP1-RA (exenatide) or 0.9% NaCl
Mood assessment
Time frame · Baseline
Registry description
Association 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
Time frame · Baseline
Registry description
Association 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
Time frame · Baseline
Registry description
Association between Barratt Impulsiveness Scale (range from 30 to 120, higher scores indicate greater impulsivity) and baseline oxytocin concentration (pg/mL)
Alexithymia assessment
Time frame · Baseline
Registry description
Association between Toronto Alexithymia scales-20 score (range from 20 to 100, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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 * Female participants will be done in the early to midfollicular phase Exclusion Criteria: * uncorrected hormone deficiency * creatinine \>1.5mg/dL * alanine aminotransferase (ALT) or aspartate amino transferase (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 * Any type of diabetes mellitus * Obese patients on GLP1-RA therapies * 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 GLP1-RA * patients refusing or unable to give written informed consent * 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.

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