Studio Del Milieu Steroideo in Pazienti Obesi
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Algorithm fo CV risk in obesity
研究概览
简要总结
The aim of this observational study is to evaluate the actual secretion of cortisol and testosterone in obese male subjects, together with the receptor sensitivity to these hormones in order to understand whether the hormonal milieu deriving from these parameters is associated with alterations in bone metabolism, lipoprotein concentration and function, and/or the severity and complications of obesity.
It will be also investigated if this hormonal milieu is a predictive factor for cardiovascular disease in obese patients.
Eligible subjects are male patients (age 18-80 years) with severe obesity and no other known causes of hypercortisolism or hypogonadism.
Questionnaires for the evaluation of mood and symptoms will be collected upon enrollment, patient's anamnestic and clinical data relating to disease complications, BMI, previous blood tests, cortisol suppression with dexamethasone 1 mg will be collected, and blood sample will be sent to and analyzed at a centralized laboratory for the study of Steroid hormones, bone metabolism, lipoprotein function, genetics and receptor analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •morbid obesity
排除标准
- •patients suffering from severe systemic pathologies, fever, chronic inflammatory states known to cause PCR >10 mg/dL
- •use of corticosteroids at the time of enrollment
- •the patient's poor understanding of spoken and written Italian
- •patients suffering from primary pathologies of the testicle, known at enrollment
- •patients suffering from hypothalamic-pituitary or adrenal pathologies already known at the time of enrollment
结局指标
主要结局
Algorithm fo CV risk in obesity
时间窗: 2024
Use of artificial intelligence methods to hypothesize an algorithm including steroid milieu that can identify obese patients at greater cardiovascular risk
Association of androgen milieu with the severity of obesity
时间窗: 2024
Evaluate the association of hypogonadism and/or androgen receptor polymorphisms that reduce sensitivity to androgens with: patients' BMI; comorbidities of obesity, and bone metabolism
Association of cortisol milieu with the severity of obesity
时间窗: 2024
Evaluate the association of hypercortisolism and/or glucocorticoid receptor polymorphisms that increase sensitivity to cortisol with: patients' BMI; comorbidities of obesity, and bone metabolism
次要结局
- Enrichment in rare HH variants in obese patients with central hypogonadism(2025)
- Prevalence of patients with morbid obesity unresponsive to overnight suppression test(2024)
- Prevalence of hypogonadism in morbid obesity(2024)
- Enrichment in rare variants associated with hypercortisolism in obese patients unresponsive to Nugent testing(2025)