Glucocorticoid Treatment in Addison's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Morning (08-09) plasma ACTH
研究概览
简要总结
Addison's disease is a rare condition which in most cases is caused by autoimmune destruction of the adrenals, leading to deficiency of cortisol, aldosterone and adrenal androgens. Unrecognized the disease is life threatening, but with proper treatment patients can live near normal lives.
The conventional glucocorticoid replacement therapy renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Glucocorticoid replacement therapy is technically feasible by continuous subcutaneous hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This study aims to further evaluate CSHI treatment in terms of metabolic effects, effects on health-related quality-of-life and sleep in an 8 months randomised open label clinical trial with crossover design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with verified Addison's disease on stable treatment.
排除标准
- •Insulin treated Diabetes Mellitus, cardiovascular disease,malignant disease, pregnancy.
- •Treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St. John's wart).
研究组 & 干预措施
Oral hydrocortisone
干预措施: Cortef (hydrocortisone) (Drug)
Continous subcutaneous hydrocortisone infusion
干预措施: Solu-Cortef (hydrocortisone) (Drug)
结局指标
主要结局
Morning (08-09) plasma ACTH
时间窗: Time 0, months 2, 3, 5, 7 and 8
次要结局
- Health-Related Quality of Life; evaluated by SF-36 vitality scores and AddiQoL scores(At time 0 and months 2,3,5,7 and 8)
- Sleep; evaluated by Pittsburgh Sleep Quality Index (PSQI), and 7-days' Actigraph registration combined with self-reported sleep diary(PSQI: 0 and months 2,3,5,7 and 8; Actigraph/sleep diary: months 2 and 7)
- 24h cortisol profiles in serum and saliva(months 2 and 7)
- S-glucose, 24 h profile(months 2 and 7)
- Insulin sensitivity assessed by euglycemic clamp(Months 2 and 7)