Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study)
- Status
- CompletedResults none
- Why it is watched
- non-weight indication: endocrine
- Who it enrolls
- age 18 Years to 65 Years; healthy volunteers accepted; no BMI minimum stated; conditions: Hypopituitarism; Central Diabetes Insipidus; Panhypopituitarism; Psychological Disorder
- Interventions
- Experimental: GLP1-RA (exenatide) administration; Control: Placebo administration
- Conditions
- Hypopituitarism; Central Diabetes Insipidus; Panhypopituitarism; Psychological Disorder; Social Isolation; Hypothalamic Diseases; Pituitary Diseases; Oxytocin Deficiency
- Phase and size
- Phase 4 · 42 participants
- Dates
- Start 2021-09-13
Primary completion 2024-04-30 - Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- 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
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.