Saliva Cortisol Measurement for the Assessment of Hydrocortisone Replacement Therapy in Secondary Adrenal Insufficiency Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Oral contamination of salivary cortisol measurement with hydrocortisone taken in tablet form.
研究概览
简要总结
Patients with adrenal insufficiency are most often overdosed with hydrocortisone. To date, there is no reliable marker that can reflect the quality of hydrocortisone substitution. Salivary cortisol is a good reflection of free plasmatic cortisol. However, salivary contamination with the oral intake of hydrocortisone has been described.
The aims of the study are to:
- evaluate the frequency of salivary contamination by hydrocortisone taken in tablet form and determine its risk factors.
- evaluate the quality of hydrocortisone substitution in patients with corticotrope deficiency.
详细描述
Patients with adrenal insufficiency are most often overdosed with hydrocortisone, as evidenced by the higher frequency of metabolic disorders, osteoporosis and cardiovascular mortality in these subjects compared to healthy subjects. To date, there is no reliable marker that can reflect the quality of hydrocortisone substitution. Salivary cortisol is a good reflection of free plasmatic cortisol. However, salivary contamination with the oral intake of hydrocortisone has been described.
The aims of the study are to:
- evaluate the frequency of salivary contamination by hydrocortisone taken in tablet form and determine its risk factors.
- evaluate the quality of hydrocortisone substitution in patients with corticotrope deficiency.
It is a cross over clinical trial with three arms: patients taking tablets of hydrocortisone, patients taking capsules of hydrocortisone, and healthy control subjects undergoing one day test. Salivary cortisol is measured before, at one, two and four hours after hydrocortisone intake.
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
- Double (Participant, Care Provider)
盲法说明
healthy volunteers
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with corticotrope deficiency treated with hydrocortisone for at least one year.
排除标准
- •alcoholism,
- •morbid obesity,
- •long standing or uncontrolled diabetes mellitus,
- •uncontrolled hypothyroidism,
- •depression,
- •chronic or acute inflammatory or infectious disease,
- •neoplasia,
- •renal or hepatic disease,
- •malabsorption,
- •pregnant or breast-feeding women,
- •treatment with corticosteroids other than hydrocortisone, enzyme inducers or oestrogens.
研究组 & 干预措施
capsule hydrocortisone intake in patients with corticotrope deficiency
Hydrocortisone taken in capsule form (15mg), one intake/ one day test.
干预措施: Hydrocortisone (capsule) (Drug)
tablet hydrocortisone intake in patients with corticotrope deficiency
Hydrocortisone taken in tablet form (15mg), one intake/ one day test.
干预措施: Hydrocortisone (capsule) (Drug)
结局指标
主要结局
Oral contamination of salivary cortisol measurement with hydrocortisone taken in tablet form.
时间窗: during the four hours test
very high salivary cortisol levels after the intake of hydrocortisone in tablet form as compared with capsule form.
次要结局
- Evaluation of the quality of the substitution of corticotrope deficiency with hydrocortisone using salivary cortisol measurement(salivary cortisol levels during the four hours test)
研究者
Melika Chihaoui
professor
University Tunis El Manar