Saliva Cortisol Measurement as a Screening Test for Suspicious Cushings Syndrome in Children.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of patients With negative saliva cortisol measurement , having Cushings syndrome.
研究概览
简要总结
Cortisol overproduction ( Cushings syndrome) is a condition where the patient have a special fat distribution, with accumulation of fat around the abdomen and in the neck, with thinner limbs and weak musculature. The condition can be difficult to separate from adipositas in general. Screening for hypercortisolism in adults has been easier the last years, because we can measure free cortisol in saliva samples at late night. In children we still dont have reference ranges for saliva cortisol in children, so the screening is still troublesome, based on Collection of 24-hour urine.The meaning of this study is to establish reference ranges for saliva cortisol, and evaluate in a cohort with adipose children if screening with saliva cortisol is sensitive and specific enough to be the New screening test for hypercortisolism in children too.
详细描述
the investigators have collected saliva samples morning and late evening for cortisol measurements in a total of 330 children ( 660 samples) in the age from 4 to 16 years ols. This samples are going to be used to define a reference range for saliva cortisol in children.
The investigators are then collecting 24 hour urine and saliva samples ( morning and late evening) from children at the obesity clinic Haukeland University hospital for verification of the reference range , and to estimate if the test is good enough to identify the patients that have Cushings syndrome.
Since the diagnose is very seldom in children, we will get help from a 3. line referral center in London to include patients with true Cushings syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-16 years. Healthy population from selected kindergarten and Schools, and patients refered to the obesity clinic Haukeland University Hospital, for examination and optionally treatment.
排除标准
- •Use of any kind of steroids ( oral, liniments, inhalations etc)
结局指标
主要结局
Number of patients With negative saliva cortisol measurement , having Cushings syndrome.
时间窗: 2 years
Number of patients
Number of patients with positive saliva cortisol measurement, not having Cushings syndrome.
时间窗: 2 years
Number of patients
次要结局
未报告次要终点