Hypopituitarism
Conditions
Interventions
Trade Name: Byetta
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: EXENATIDE
CAS Number: 141758-74-9
Concentration unit: µg/kg microgram(s)/kilogram
Concentration ty
Sponsors
Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age: 18 to 65 years Patients with hypopituitarism (HYPO) (> 1 pituitary hormonal deficit) with at least one clinical sign of hypothalamic damage (eg central diabetes insipidus and / or severe obesity and / or hyperphagia; MRI suggestive of hypothalamic damage, brain trauma, radiation, tumors affecting the hypothalamus (craniopharyngioma, germinoma ...) Healthy controls (HC) balanced by body mass index (BMI, if possible), age and sex with HYPO patients. HYPO patients should be on stable hormone replacement therapy for three months prior to the study. Participating women will undergo visits in the follicular phase (between day 1 and 10 of the menstrual cycle) to minimize the effects of the increase in estradiol in other phases of the menstrual cycle on OT levels, and postmenopausal HYPO women will be compared with controls of similar age. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Uncorrected hormonal deficiency, creatinine> 1.5mg / dL, ALT or AST> 2.5x above the normal limit, hematocrit <30%, active psychosis, participation in clinical trials with drugs, experiencing them in the last 30 days, excessive physical activity or intake of alcohol 24 hours prior to study participation, evidence of any acute illness or that the investigator determines could interfere with study participation and safety, pregnancy or lactation 8 weeks prior, allergies or known hypersensitivity to CRH. Patients receiving high doses of glucocorticoids (higher than replacement doses). Patients who refuse or cannot give informed consent in writing. In addition, for CS, the presence of a brain or pituitary tumor, irradiation that affects the hypothalamus or pituitary, a history of hypopituitarism or that are being treated with testosterone, glucocorticoids or GLP1 receptors analogues.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To improve the knowledge about the physiology and pathophysiology of endogenous oxytocin (OT) secretion in patients with hypopituitarism (HYPO) compared to healthy controls (HC).;Secondary Objective: - Analyze the secretion patterns and dynamics of OT in response to the administration of the agent under study (CRH vs. placebo) to better understand the physiology (in HC) and pathophysiology (in HYPO) of the secretion of OT in humans. - Identify a possible OT deficient state in patients (HIPO) with a higher risk of suffering an alteration in the OT system in response to the stimulus (CRH vs. Placebo) compared to HC. - To evaluate the clinical implications of OT secretion patterns (peak, nadir, change from baseline, area under the curve ...) after administration of CRH or placebo, in HYPO compared to HC, specifically the associations with measures of mood (anxiety and depression), alexithymia, impulsivity, quality of life, eating behavior and sexual function; using validated questionnaires.;Primary end point(s): Baseline OT concentrations (T0), OT concentrations (T15, T30, T45, T60, T90, T120), peak and nadir of OT concentrations, relative change in OT concentrations (basal to nadir and peak), area under the curve of OT (AUC) and AUC with respect to increase (AUCi) as an integrated measure of the changes in OT after stimulation, using the trapezoidal formula. As well as the ACTH and cortisol secretion parameters.;Timepoint(s) of evaluation of this end point: Baseline (T0), T15, T30, T45, T60, T90, T120 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Results of validated questionnaires for the evaluation of mood, alexithymia, impulsivity, quality of life, eating behavior and sexual function and their associations with OT secretion parameters. Glucose secretion, insulin and GLP1 parameters after agent / placebo administration and their relationship with OT secretion parameters. Variables obtained in the life satisfaction questionnaires, compassion levels and current emotion levels; and its relationship with the OT secretion patterns of the samples obtained in blood and saliva.;Timepoint(s) of evaluation of this end point: Baseline, during the intervention and after the intervention | — |
Countries
Spain
Contacts
Public ContactUICEC Sant Pau
Institut de Recerca H. Santa Creu i Sant Pau
Outcome results
None listed