临床试验/NCT02227420

NCT02227420已完成3 期

Effects of IL-1 Beta on the Hypothalamic-pituitary-adrenal (HPA) Axis in Obese Persons - the CortIL-Study

University Hospital, Basel, Switzerland1 个研究点分布在 1 个国家目标入组 76 人开始时间: 2014年10月最近更新: 2016年8月23日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 76
试验地点: 1
主要终点: Morning cortisol levels

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In obese individuals cortisol production and secretion is increased but the underlying mechanism is not known. Obesity leads to a pathological activation of the innate immune system partly driven by tissue production of IL-1β. Furthermore, IL-1β is also known to stimulate the release of adrenocorticotropin hormone (ACTH). Therefore, the investigators hypothesise that in obese individuals tissue inflammation stimulates ACTH via IL-1β, thereby explaining the observed hypercortisolism.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
盲法: None

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age 18-80 years
•BMI >30kg/m2 and at least 1 manifestations of the metabolic syndrome (i.e. diabetes/ prediabetes, hypertension, dyslipidemia)
•Willingness to use contraceptive measures adequate to prevent becoming pregnant

排除标准

•Medication with glucocorticosteroids
•Known Cushing Syndrome
•Pregnancy or breast feeding
•Clinical signs of infection in the week before inclusion or history of a severe infection during the last 2 months
•Hematologic disease (leukocyte count < 1.5x109/l, hemoglobin <11 g/dl, platelets <100 x 103/ul)
•Kidney disease (creatinine-clearance < 30ml/min))
•Liver disease (transaminases >4x upper normal range)
•Active carcinoma
•History of tuberculosis
•Alcohol consumption >40g/d for men, >30g/d for women
•Known allergy towards anakinra
•Subject refusing or unable to give written informed consent

研究组 & 干预措施

Anakinra

Experimental

Anakinra 100mg s.c. x 5

干预措施: Anakinra (Drug)

结局指标

主要结局

Morning cortisol levels

时间窗: 14 days

次要结局

impact of anakinra/Kineret® on other pituitary and peripheral hormones, such as: ACTH, TSH, fT4, GH, IGF-1, LH, FSH, testosterone copeptin, IL-6, CRP, leukocyte count and body temperature.(14 days)
effect of anakinra/Kineret® on salivary cortisol, free urinary cortisol, and serum cortisol levels after an overnight dexamethasone suppression test(14 days)
correlation between the percentage of body fat or body mass index, and suppression of cortisol levels after injection of anakinra/Kineret®(14 days)
comparison of 1mg and 2mg dexamethasone suppression test(4 weeks)
correlation between inflammatory parameters with cortisol levels(14 days)

研究者

发起方

University Hospital, Basel, Switzerland

申办方类型

Other

责任方

Sponsor

研究点 (1)

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