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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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, corticorelin hormone (CRH) has shown to increase OT release.
This study is designed to evaluate oxytocin values after administration of CRH in adults (healthy volunteers and patients with hypopituitarism).
The investigators hypothesize that OT response will be blunted following CRH in patients with hypopituitarism compared to healthy controls.
This research is focused on two groups of participants: healthy controls (HC) and hypopituitary patients (HYPO) with at least one symptom of hypothalamic damage, presumably at highest risk for OT deficiency.
The aim is to improve knowledge on the physiology and patho-physiology of endogenous OT secretion in hypopituitary patients compared to healthy controls using a randomized, single-blind, crossover assignment (CRH vs placebo), placebo-control design.
Clinical implications of secretory OT dynamics and release under different stimuli using validated questionnaires to evaluate psychopathology, socio-emotional functioning, disordered eating behavior, impaired quality of life and sexual dysfunction, will be also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRH administration | Experimental | Experimental: CRH administration |
|
| Placebo administration | Placebo Comparator | Control: Placebo administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: CRH administration | Drug | CRH at 1.0 µg/kg/body weight will be injected intravenously as a bolus over 30 seconds and samples will be collected over 2 hours (15 (T15), 30 (T30), 45 (T45), 60 (T60'), 90 (T90) and 120 (T120) minutes) after CRH:placebo administration to assess OT secretory patterns |
| Measure | Description | Time Frame |
|---|---|---|
| Change in oxytocin concentration | Change in oxytocin concentration (pg/mL) after administration of 1.0 µg/kg/body weight of CRH or 0.9% sodium chloride (NaCl) | Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 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 1.0 µg/kg/body weight of CRH or 0.9% NaCl | Within the two hours after the injection |
| Overall oxytocin secretion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Aulinas, MD PhD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39824923 | Derived | Asla Q, Garrido M, Urgell E, Terzan S, Santos A, Fernandez M, Varghese N, Atila C, Calabrese A, Biagetti B, Plessow F, Gich I, Christ-Crain M, Eckert A, Webb SM, Lawson EA, Aulinas A. Oxytocin levels in response to CRH administration in hypopituitarism and hypothalamic damage: a randomized, crossover, placebo-controlled trial. Sci Rep. 2025 Jan 18;15(1):2360. doi: 10.1038/s41598-025-86566-y. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 26, 2024 | |
| Reset | Nov 7, 2024 |
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Single-blind, randomized, placebo-controlled proof-of-concept studies with a crossover assignment
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participants will be blinded to the intervention assignment
|
| Control: Placebo administration | Drug | Sodium Chloride 0.9% will be administered intravenously as a bolus over 30 seconds at equivalent volume than CRH administration (1.0 µg/kg/body weight) |
|
Oxytocin area under the curve after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl
| Within the two hours after the injection |
| Change in cortisol concentration (nmol/L) | Change in cortisol concentration (nmol/L) after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl | Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection |
| Change in adrenocorticotropic hormone (ACTH) values | Change in ACTH values (pmol/L) after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl | Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection |
| 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) | 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) | Baseline |
| Impulsivity assessment | Correlation between Barratt Impulsiveness Scale (range from 30 to 120, higher scores indicate greater impulsivity) and baseline oxytocin concentration (pg/mL) | 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) | Baseline |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 26, 2024 | Nov 7, 2024 |
| ID | Term |
|---|---|
| D007018 | Hypopituitarism |
| D020790 | Diabetes Insipidus, Neurogenic |
| C580003 | Combined Pituitary Hormone Deficiency |
| D001523 | Mental Disorders |
| D012934 | Social Isolation |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D003919 | Diabetes Insipidus |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
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