DRUG
Experimental: GLP1-RA (exenatide) administration
a single dose of 10 mcg of GLP-RA (exenatide) will be administered subcutaneously and samples to assess OT secretory patterns will be collected over 2 hours
Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study)
Status
Completed
Phase
Phase 4
Enrollment
42
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full detailed description
This research is focused on two groups of participants: healthy controls (HC) and hypopituitary patients (HYPO) with at least one symptom of hypothalamic damage, presumably at highest risk for OT deficiency. The aim is to improve knowledge on the physiology and patho-physiology of endogenous OT secretion in hypopituitary patients compared to healthy controls using a randomized, single-blind, crossover assignment (GLP1-RA vs placebo), placebo-control design. Clinical implications of secretory OT dynamics and release under different stimuli using validated questionnaires to evaluate psychopathology, socio-emotional functioning, disordered eating behavior, impaired quality of life and sexual dysfunction, will be also evaluated.
Interventions
Treatment arms and agents.
DRUG
Control: Placebo administration
Sodium Chloride 0.9% will be administered subcutaneously at equivalent volume than 10 mcg of exenatide
Timeline
From registration to results.
First posted
May 24, 2021
Study start
Sep 13, 2021
Primary completion
Apr 30, 2024
Study completion
Dec 31, 2024
Results posted
Not reported
Registry updated
Jan 20, 2026
Outcomes
What the study measures.
Primary outcomes
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
Change in oxytocin concentration (pg/mL) after administration of 10 µg of GLP1-RA (exenatide) or 0.9% sodium chloride (NaCl)
Secondary outcomes
Maximal change in oxytocin concentration (pg/mL)
Time frame · Within the two hours after the injection
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
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
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
Change in insulin concentration (pmol/L) after administration of 10 µg of GLP1-RA (exenatide) or 0.9% NaCl
Mood assessment
Time frame · Baseline
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
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
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
Association between Toronto Alexithymia scales-20 score (range from 20 to 100, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- 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 * 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.
Study locations
1 registered sites.
Spain. Showing up to 24 locations stored in the fast local snapshot.
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Exenatide.
NCT IDStudyPhase / statusEnrollmentUpdated
Determination of Resistance Training Status for Patients on Glucagon-Like Peptide-1 Receptor Agonists
Ohio State University · Obesity & Overweight · Diabetes (DM)
Not applicable
Recruiting
300
2026-07
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Johns Hopkins University · Multiple Sclerosis
Phase 2
Recruiting
120
2026-07
A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients Who Initiated Exenatide as Compared With Those Who Initiated Other Non-Glucagon-Like Peptide 1 Receptor Agonists Based Glucose Lowering Drugs
AstraZeneca · Pancreatic Cancer
Not applicable
Recruiting
24,000
2026-06
GLP-1 Analogue in Preventing Progression of Small Vessel Disease (GAPP-SVD)
Chinese University of Hong Kong · Cerebral Small Vessel Disease
Phase 2
Recruiting
110
2026-06
Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
University Hospital, Bordeaux · Craniopharyngiomas · Hypothalamic Obesity
Phase 3
Completed
42
2026-05
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
Brigham and Women's Hospital · Cardiovascular Events · Type2 Diabetes
Not applicable
Active, not recruiting
781,430
2026-05
Effect of GLP-1 Receptor (GLP-1R) Agonists on Cardiac Function and on Epicardial Adipose Tissue (EAT) Volume and on Myocardial TG Content in Obese Diabetics
Assistance Publique Hopitaux De Marseille · Obesity · Diabetes
Phase 3
Completed
44
2026-05
Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease
University College, London · Parkinson's Disease
Phase 3
Completed
194
2026-05
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.