Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Presence of central adrenal insufficiency using low dose (1 mcg) ACTH stimulation test
研究概览
简要总结
The purpose of this study is to determine presence of central adrenal insufficiency in children with Prader Willi Syndrome using low dose (1 mcg) ACTH stimulation test compared to results of overnight metyrapone test.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with Prader Willi Syndrome ages 2 years and older
排除标准
- •Individuals who are ill at the time of study
- •Individuals who are pregnant at the time of study
- •Individuals who it is deemed unsafe to stop taking medications known to affect the results of they study (hydrocortisone, phenytoin, estrogen, acetaminophen, oral anti-diabetic agents).
研究组 & 干预措施
Assessment of Central Adrenal Insufficiency
Patients will undergo low dose ACTH stimulation test followed by overnight metyrapone test to assess for central adrenal insufficiency.
干预措施: Low dose (1 mcg) ACTH stimulation test (Other)
Assessment of Central Adrenal Insufficiency
Patients will undergo low dose ACTH stimulation test followed by overnight metyrapone test to assess for central adrenal insufficiency.
干预措施: Overnight metyrapone test (Other)
结局指标
主要结局
Presence of central adrenal insufficiency using low dose (1 mcg) ACTH stimulation test
时间窗: 40 minutes
Prescence of central adrenal insufficiency using overnight metyrapone test
时间窗: 8 hours
次要结局
- Determine peak cortisol value on low dose (1 mcg) ACTH stimulation test that can accurately predict central adrenal insufficiency based on overnight metyrapone test with good sensitivity and specificity.(0)
研究者
Manmohan Kamboj
Associate Professor of Pediatrics, Section of Endocrinology, Metabolism and Diabetes
Nationwide Children's Hospital