Identification and Clinical Relevance of an Oxytocin Deficient State: a Randomized, Crossover, Placebo-controlled, Proof-of-concept, Physiopathological Study (GLP1 Study)

Registration

Registration

NCT04897802

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE4

Masking

SINGLE

Status

COMPLETED

Enrollment

42

Start

2021-09-13

Primary completion

2024-04-30

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Conditions

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

Interventions

DRUG:Experimental: GLP1-RA (exenatide) administration; DRUG:Control: Placebo administration

Results posted

FALSE

Registered primary outcomes

• Change in oxytocin concentration (pg/mL) [Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection]