Identification and clinical relevance of oxytocin deficient status: GLP1 study

Phase 1

• Conditions: Hypopituitarism; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2020-004115-27-ES
• Lead Sponsor: Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-01
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 52

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified