Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04897802
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2021-05-17
Brief Title:
Identification and Clinical Relevance of an Oxytocin Deficient State GLP1 Study
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Identification and Clinical Relevance of an Oxytocin Deficient State a Randomized Crossover Placebo-controlled Proof-of-concept Physiopathological Study GLP1 Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None