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临床试验/NCT03211624
NCT03211624进行中(未招募)不适用

The Etiology and Extent of Impaired Quality of Life, Fatigue and Cognitive, Affective and Emotional Dysfunction in Patients With Cushing's Syndrome - Prospective Studies

Göteborg University3 个研究点 分布在 3 个国家目标入组 72 人开始时间: 2017年5月1日最近更新:
适应症

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

  1. 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

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)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (3)

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