Evaluating the effects of GLP1 on oxytocin levels in patients with hypopituitarism
Identification and Clinical Relevance of an Oxytocin Deficient State: a Randomized, Crossover, Placebo-controlled, Proof-of-concept, Physiopathological Study (GLP1 Study)
This study is testing whether a medication that mimics a hormone can change oxytocin levels in adults with hypopituitarism to see how it affects their mood and social life.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT04897802 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between glucagon-like peptide 1 (GLP1) and oxytocin (OT) levels in adults, focusing on patients with hypopituitarism and healthy controls. Participants will receive either GLP1 receptor agonist (exenatide) or a placebo in a randomized, single-blind, crossover design. The study aims to assess the physiological response of OT secretion following GLP1 administration and its implications for psychopathology, social functioning, and quality of life. Validated questionnaires will be used to evaluate various psychological and social outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with hypopituitarism who have been stable on hormone replacement therapy for at least three months and exhibit at least one symptom of hypothalamic damage.
Not a fit: Patients with uncorrected hormone deficiencies, active psychosis, or those who have participated in other investigational drug trials recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of oxytocin's role in patients with hypopituitarism and lead to improved treatment strategies for associated psychological and social dysfunctions.
How similar studies have performed: While some studies have suggested a link between GLP1 and oxytocin release, this specific approach is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Anna Aulinas, MD PhD — IR-Sant Pau
- Study coordinator: Anna Aulinas, MD PhD
- Email: aaulinas@santpau.cat
- Phone: +34 932919000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.