2024-515588-67-00已完成2 期
Identification and clinical relevance of an oxytocin-deficient state: randomized, crossover, placebo-controlled pilot physiopathological study: GLP1 Study.
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年6月26日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Pattern of OT hormone secretion after administration of the study agent (GLP1 vs. placebo).
研究概览
简要总结
Improve knowledge of endogenous OT secretion in patients with hypopituitarism and CS.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years.
- •Patients with hypopituitarism (HIPO), defined as more than one pituitary hormone deficit, with at least one clinical sign of hypothalamic damage.
- •Clinical signs of potential hypothalamic damage are considered to be the presence of at least one of the following: .central diabetes insipidus and/or severe obesity and/or hyperphagia and/or MRI suggestive of hypothalamic damage history of traumatic brain injury .history of irradiation of tumors affecting the hypothalamic region (e.g., craniopharyngioma, germinoma, etc.).
- •HIPO patients must be on stable hormone replacement therapy for three months prior to the prior to the study.
- •Participating women will make visits in follicular phase (between day 1 and 10 of the menstrual cycle) to minimize the effects of increased estradiol in other phases of the menstrual cycle on OT levels (23), and postmenopausal HIPO women will be compared with age-matched controls.
- •Healthy controls (HC) balanced by body mass index (BMI, if possible), age and sex with HIPO patients sex with HIPO patients.
排除标准
- •Uncorrected hormone deficiency.
- •Pregnancy or breastfeeding the 8 weeks before.
- •Known allergies or hypersensitivity to GLP1 receptor analogues or to some of the excipients (methacresol mannitol, glacial acetic acid, sodium acetate trihydrate). excipients (methacresol mannitol, glacial acetic acid, sodium acetate trihydrate).
- •Diabetes mellitus or under treatment with any diabetes drug.
- •Pancreatitis.
- •Patients under treatment with high doses of glucocorticoids (higher than substitute doses).
- •Potentially fertile women (after menarche and before postmenopause unless permanently sterilized by hysterectomy, salpinguectomy, or salpinguectomy. unless they have been permanently sterilized by hysterectomy, bilateral salpinguectomy and bilateral and bilateral oophorectomy) and are unwilling to take highly effective contraceptive measures during the study period highly effective contraceptive measures during the study period: combined contraceptive treatment with estrogens and progestogens associated with ovulation inhibition (oral, intravaginal, or (oral, intravaginal or transdermal), intrauterine device, sexual abstinence (abstinence from heterosexual intercourse) during the (abstinence from heterosexual intercourse) during the entire risk period associated with the study, taking into account the patient's or vascular the situation of the vasectomized patient or partner.
- •Patients who refuse or are unable to give written informed consent.
- •In addition, for CS: Presence of brain or pituitary tumor. Irradiation involving the hypothalamus or pituitary gland History of hypopituitarism History of hypopituitarism -History of testosterone, glucocorticoids or GLP1 receptor analogues. GLP1 RECEPTOR ANALOGUES.
- •Creatinine >1.5mg/dL.
- •ALT or AST >2.5x above the limit of normality.
- •Hematocrit <30%.
- •Active psychosis.
- •Participation in clinical trials with experimental drugs in the last 30 days.
- •Excessive physical activity.
- •Alcohol intake in the 24 hours prior to study participation.
- •Evidence of any acute illness or disease that the investigator determines may interfere with study participation and safety. interfere with study participation and safety.
结局指标
主要结局
Pattern of OT hormone secretion after administration of the study agent (GLP1 vs. placebo).
Pattern of OT hormone secretion after administration of the study agent (GLP1 vs. placebo).
次要结局
- Secondary variables will be those related to the results of validated questionnaires for the assessment of mood, alexithymia, impulsivity, quality of life, eating behavior and sexual function and their associations with OT secretion parameters.
研究者
Alejandra Espinosa Guerrero
Scientific
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
研究点 (1)
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