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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with hypopituitarism | Experimental | A single dose of melatonin administration |
|
| Healthy controls | Active Comparator | A single dose of melatonin administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Dietary Supplement | A single dose of melatonin (1.9 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in oxytocin concentration | Change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin orally. | Baseline blood exam (timepoint 0) and further blood collections after 30, 60, 90 and 120 minutes after baseline blood collection |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal change in oxytocin concentration (pg/mL) | Maximal change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin administered orally. | Within the two hours after the injection |
| Overall oxytocin secretion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
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Oxytocin area under the curve after administration of 1.9 melatonin administered orally
| Within the two hours after the injection |
| Mood assessment | Correlation between Beck Depression Inventory-2 score (range from 0 to 63, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL) | At baseline |
| Quality of life assessment | 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) | At baseline |
| Impulsivity assessment | Correlation between Barratt Impulsiveness Scale (range from 30 to 120, higher scores indicate greater impulsivity) and baseline oxytocin concentration (pg/mL) | At baseline |
| Alexithymia assessment | Correlation between Toronto Alexithymia scales-20 score (range from 20 to 100, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL) | At baseline |
| ID | Term |
|---|---|
| D007018 | Hypopituitarism |
| D050035 | Sexual Infantilism |
| D020790 | Diabetes Insipidus, Neurogenic |
| D012934 | Social Isolation |
| ID | Term |
|---|---|
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D006059 | Gonadal Dysgenesis |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006058 | Gonadal Disorders |
| D007006 | Hypogonadism |
| D003919 | Diabetes Insipidus |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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