NCT01156519终止不适用
Detection of Infra-clinic Cortisol Adenoma (ACIC) in a Population of Android Obese With High Metabolic Risk: Contribution of Salivary Cortisol at 23 Hours
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 514
- 试验地点
- 1
- 主要终点
- Number of patients with positive salivary cortisol dosage among patients with positive serum cortisol dosage
研究概览
简要总结
The main objective of the study is to assess the sensitivity of the salivary cortisol dosage at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone suppression test (Suppression of serum cortisol <1.8 μg/dL ) as the reference method for the detection of ACIC in obese subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years)
- •Signed informed consent
- •Subjects affiliated with an appropriate social security system
- •Body mass index above 30 kg/m2 and
- •Pathological waist circumference according to criteria of NCEP ATPIII (men : 94 cm and women : 80 cm)
排除标准
- •Pregnancy
- •Recent surgery (less than 30 days)
- •Any recent severe acute conditions requiring hospitalisation (less than 30 days)
- •Recent use (< 7 days) of oral steroids, inhaled, dermal, collyrium, infiltration
- •Long-term oral corticosteroids
- •Nicotinic substitute or per os licorice in 2 weeks before the inclusion
结局指标
主要结局
Number of patients with positive salivary cortisol dosage among patients with positive serum cortisol dosage
The main objective of the study is to assess the sensitivity of the salivary cortisol dosage at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone suppression test as the reference method for the detection of ACIC in obese subjects
次要结局
- Comparing the results of the two salivary samples
- Comparing the results of salivary cortisol dosage and serum cortisol dosage
- Number of patients with negative salivary cortisol dosage among patients with negative serum cortisol dosage
- Number of patients with metabolic complications of obesity among patients with ACIC
- Number of patients with severe type 2 diabetes among patients with ACIC
研究者
研究点 (1)
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