Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- serum cortisol-peak 30 min after ACTH-stimulation
研究概览
简要总结
The purpose of this study is to determine whether patients with Hashimoto thyroiditis and impaired well-being may have a partial secondary adrenocortical insufficiency.
详细描述
Many patients with Hashimoto thyroiditis who are correctly substituted with thyroid hormones have an impaired well-being. in some people an isolated ACTH deficiency was found.
In this study a 1 µg ACTH test is performed to evaluate the adrenocortical function.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Hashimoto thyroiditis euthyreot thyroid function with levothyroxin therapy written informed consent
排除标准
- •• hypothyroidism of other origin
- •pregnancy and lactation
- •oral contraception
- •glucocorticoid therapy during the last 2 months
- •History of malignancy or chronic infections (Hepatitis, HIV)
研究组 & 干预措施
1
healthy people without Hashimoto disease receive a 1µg ACTH stimulation test
干预措施: synacthen (Drug)
2
patients with Hashimoto disease with well being receive a 1 µg ACTH stimulation test
干预措施: synacthen (Drug)
3
patients with Hashimoto disease an impaired well-being receive a 1 µg ACTH stimulation test
干预措施: synacthen (Drug)
4
patients with Hashimoto disease and negative TPO antibodies receive a 1µg ACTH stimulation test
干预措施: synacthen (Drug)
结局指标
主要结局
serum cortisol-peak 30 min after ACTH-stimulation
时间窗: 30 minutes
次要结局
- serum DHEA-peak 30 min. after ACTH-stimulation,DHEA-S, ACTH(30 minutes)