Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study)

Launched by FUNDACIÓ INSTITUT DE RECERCA DE L'HOSPITAL DE LA SANTA CREU I SANT PAU · May 20, 2021

Keywords

ClinConnect Summary

The GLP1 Study is looking at how a hormone called oxytocin (OT) works in people with a condition known as hypopituitarism, which means their pituitary gland isn’t producing enough hormones. This study is specifically exploring whether giving a medication called glucagon-like peptide 1 (GLP1) can help increase oxytocin levels in these patients. Researchers believe that people with hypopituitarism may not respond as well to GLP1 compared to healthy individuals, which could affect their appetite, mood, and social behavior.

To participate in the study, individuals must be between the ages of 18 and 70 and have been diagnosed with hypopituitarism, meaning they have deficiencies in more than one pituitary hormone and have been stable on hormone replacement therapy for the last three months. Participants can expect to receive GLP1 and have their oxytocin levels measured. It's important to note that certain health conditions, recent treatments, or medications may exclude someone from participating, including active psychological disorders or recent participation in other drug trials. This research aims to better understand the role of oxytocin in managing the effects of hypopituitarism and could lead to improved treatments in the future.

Gender

ALL

Eligibility 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.