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

NCT04897802 | Completed Phase 4

• 1 other identifier: IIBSP-OXI-2020-102
• Study Type: interventional
• Target: 42
• 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, 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.

Conditions

Hypopituitarism; Central Diabetes Insipidus; Panhypopituitarism; Psychological Disorder; Social Isolation; Hypothalamic Diseases; Pituitary Diseases; Oxytocin Deficiency

Keywords

oxytocin; hypopituitarism; diabetes insipidus; hypothalamic-pituitary diseases; psychopathology; exenatide

Outcome Measures

Primary Outcomes (1)

• Change in oxytocin concentration (pg/mL)

  Change in oxytocin concentration (pg/mL) after administration of 10 µg of GLP1-RA (exenatide) or 0.9% sodium chloride (NaCl)

  Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection

Secondary Outcomes (8)

• Maximal change in oxytocin concentration (pg/mL)

  Within the two hours after the injection

• Overall oxytocin secretion (pg/mL)

  Within the two hours after the injection

• Change in glucose concentration (mg/dL)

  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)

  Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection

• Mood assessment

  Baseline

Study Arms (2)

Experimental: GLP1-RA administration

EXPERIMENTAL

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

Drug: Experimental: GLP1-RA (exenatide) administration

Control: Placebo administration

PLACEBO COMPARATOR

Sodium Chloride 0.9% will be administered subcutaneously at equivalent volume than GLP1-RA (exenatide) administration

Drug: Control: Placebo administration

Interventions

Experimental: GLP1-RA (exenatide) administration DRUG

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

Also known as: exenatide administration

Experimental: GLP1-RA administration

Control: Placebo administration DRUG

Sodium Chloride 0.9% will be administered subcutaneously at equivalent volume than 10 mcg of exenatide

Also known as: placebo administration (sodium chloride)

Control: Placebo administration

Eligibility Criteria

• Age: 18 Years - 65 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
• Female participants will be done in the early to midfollicular phase

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

MeSH Terms

Conditions

Hypopituitarism; Diabetes Insipidus, Neurogenic; Combined Pituitary Hormone Deficiency; Mental Disorders; Social Isolation; Hypothalamic Diseases; Pituitary Diseases; Diabetes Insipidus

Interventions

Exenatide; Organization and Administration; Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Health Services Administration; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Anna Aulinas, MD PhD

  IR-Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 24, 2021
• Study Start: September 13, 2021
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 20, 2026

Record last verified: 2024-03

Locations

ES (1)