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NCT Number: NCT04902235

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

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.

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Key information

Conditions

Hypopituitarism Behavior Brain Diseases Central Diabetes Insipidus Central Nervous System Diseases Combined Pituitary Hormone Deficiency Diabetes Insipidus Diabetes Insipidus, Neurogenic Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypothalamic Diseases Kidney Diseases Male Urogenital Diseases Mental Disorders Nervous System Diseases Oxytocin Deficiency Panhypopituitarism Pituitary Diseases Psychological Disorder Social Behavior Social Isolation Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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 CRH
  • 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.

Treatment and study plan

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

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)

Primary outcomes

  1. Change in oxytocin concentration

    Time frame: Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection

    Change in oxytocin concentration (pg/mL) after administration of 1.0 µg/kg/body weight of CRH or 0.9% sodium chloride (NaCl)

Secondary outcomes

  1. Maximal change in oxytocin concentration (pg/mL)

    Time frame: Within the two hours after the injection

    Maximal change in oxytocin concentration (pg/mL) after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl

  2. Overall oxytocin secretion

    Time frame: Within the two hours after the injection

    Oxytocin area under the curve after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl

  3. Change in cortisol concentration (nmol/L)

    Time frame: Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection

    Change in cortisol concentration (nmol/L) after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl

  4. Change in adrenocorticotropic hormone (ACTH) values

    Time frame: Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection

    Change in ACTH values (pmol/L) after administration of 1.0 µg/kg/body weight of CRH or 0.9% NaCl

  5. Mood assessment

    Time frame: 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)

  6. Quality of life assessment

    Time frame: 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)

  7. Impulsivity assessment

    Time frame: Baseline

    Correlation between Barratt Impulsiveness Scale (range from 30 to 120, higher scores indicate greater impulsivity) and baseline oxytocin concentration (pg/mL)

  8. Alexithymia assessment

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

Identification and Clinical Relevance of an Oxytocin Deficient State: a Randomized, Crossover, Placebo-controlled, Proof-of-concept Physiopathological Study (CRH Study)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 26, 2021
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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