Central Diabetes Insipidus, Hypopituitarism, Hypothalamic Obesity, Oxytocin Deficiency, Pituitary Dysfunction, Social Isolation
Conditions
Keywords
oxytocin, melatonin, hypopituitarism, vasopresin deficiency
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, melatonin has shown to increase OT release. This study is designed to evaluate oxytocin values after administration of melatonin in adults (healthy volunteers and patients with hypopituitarism). The investigators hypothesize that OT response will be blunted following melatonin in patients with hypopituitarism compared to healthy controls.
Interventions
DIETARY_SUPPLEMENTMelatonin
A single dose of melatonin (1.9 mg)
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Exclusion criteria
* uncorrected hormone deficiency * creatinine \>1.5mg/dL * alanine aminotransferase (ALT) or aspartate aminotransferase (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 * 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 melatonin * patients refusing or unable to give written informed consent * patients receiving fluvoxamine and/or impossibility to stop hypnotics 48 hours prior to the study visit. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in oxytocin concentration | Baseline blood exam (timepoint 0) and further blood collections after 30, 60, 90 and 120 minutes after baseline blood collection | Change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin orally. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall oxytocin secretion | Within the two hours after the injection | Oxytocin area under the curve after administration of 1.9 melatonin administered orally |
| Mood assessment | At baseline | Correlation between Beck Depression Inventory-2 score (range from 0 to 63, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL) |
| Maximal change in oxytocin concentration (pg/mL) | Within the two hours after the injection | Maximal change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin administered orally. |
| Impulsivity assessment | At baseline | Correlation between Barratt Impulsiveness Scale (range from 30 to 120, higher scores indicate greater impulsivity) and baseline oxytocin concentration (pg/mL) |
| Alexithymia assessment | At baseline | Correlation between Toronto Alexithymia scales-20 score (range from 20 to 100, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL) |
| Quality of life assessment | At baseline | Correlation between 36 item- Short Form Health Survey score (range from 0 to 100, the higher scores indicate better health status) and baseline oxytocin concentration (pg/mL) |
Countries
Spain
Outcome results
None listed