The Etiology and Extent of Impaired Quality of Life, Fatigue and Cognitive, Affective and Emotional Dysfunction in Patients With Cushing's Syndrome - Prospective Studies
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Cognitive function
研究概览
简要总结
This is a prospective, multi-center, case-control study where neurocognitive function will be evaluated in 36 patients with Cushing syndrome (CS) and 36 controls matched for age, gender and education.
详细描述
- Background
Endogenous Cushing's syndrome (CS) is the collective name for several rare disorders of chronic glucocorticoid (GC) excess. The most common causes are ACTH producing pituitary adenoma [Cushing's disease (CD)], cortisol producing adrenal adenoma (CPAA) and ectopic ACTH producing tumors.
Cognitive dysfunction, psychiatric disorders, fatigue, and impaired quality of life (QoL) are frequently observed in patients with active CS. Morphological changes in the central nervous system have also been reported in patients with CS, including decreased total brain volume and hippocampal formation volume compared with healthy subjects.
After successful treatment of CS, cognitive function improves according to some studies while others have found no change from pre-treatment levels. Increased brain volume has also been reported following treatment, although not to the levels of a normal control group.
Various aspects of the neurocognitive consequences of hypercortisolism have been studied in recent years. However, a major limitation of most previous studies is the small sample size. Longitudinal research data is sparse. A further limitation is that CS is a heterogeneous disease with several etiologies, varied clinical findings at presentation and varying outcome after treatment. Consequently, and since CS is a rare syndrome, the number of patients needed to be studied is too large for a single center. A collaborative multi-centre effort is therefore a desirable approach. 2. Aim
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Cognitive function
时间窗: 2 years
Improvement in memory 2 years after treatment of Cushing syndrome evaluated with the Rey Complex Figure.
次要结局
- Brain volume(2 years)
- Functional brain response(2 years)
- Polymorphisms in the GC receptor gene or genes involved in metabolism and transport of GCs(2 years)
- Test score in CushingQoL test(2 years)
- Glucose utilization(2 years)
