Status:
RECRUITING
Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study)
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Hypopituitarism
Central Diabetes Insipidus
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 se...
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 defi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04897802
Start Date
September 13 2021
End Date
December 31 2024
Last Update
April 10 2024
Active Locations (1)
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1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041