A Single Center, Prospective, Observational Study to Explore and Evaluate the Differences of Cognitive Function and Brain Function Between Non-functioning Adrenal Adenomas and Autonomous Cortisol Secretion Patients, and the Different Treatments Methods on Cognitive Function and Brain Function in Patients With Autonomous Cortisol Secretion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Participants' personal information
研究概览
简要总结
This is a single center, prospective, observational study to explore and evaluate the differences on cognitive function and brain function by functional-MRI in autonomous cortisol secretion patients, and the different treatments methods on the cognitive function and brain function in patients with autonomous cortisol secretion
详细描述
Glucocorticoids, mainly cortisol, play a crucial role in the allostatic process of adjustment to stressors and can determine important changes in central nervous system structures. It is well known that Cushing's syndrome (CS) is associated with neurocognitive impairment in about two-thirds of cases. In CS the most frequent reported alterations are memory impairment (about 83% of cases) and reduced concentration (66% of cases) . Unfortunately, these alterations are only partially reversible after the hypercortisolism resolution. As so far, data related to the impact of autonomous cortisol secretion (ACS) on cognitive function are scarce and lack of magnetic resonance indicators. Few studies have studied the cognitive function changes of patients with ACS by surgical and conservative treatment. In the single center, prospective and observational study we aim to explore cognitive functions and brain function by functional-MRI in adrenal incidentaloma patients in relation to the presence of ACS and, secondly, in a group of acs patients, the effect of adrenalectomy on cognitive functions and brain function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 20-65 years;
- •≥ 6 years of education；
- •right-handed;
- •complete entire cognitive function tests;
- •adrenal lesions ≥ 1 cm in diameter;
- •patients with non-functioning adrenal adenomas;
- •patients with autonomous cortisol secretion.
排除标准
- •< 6 years of education;
- •age < 20 years or > 65 years;
- •maximum diameter of AI <1cm;
- •active malignancies;
- •with a history of thyroid disease;
- •with a history of acute infection in the last month;
- •central nervous system diseases, including brain trauma, intracranial hemorrhage, acute cerebral infarction, etc;
- •contraindications of MRI examination: such as implantation of metal prosthesis in vivo, claustrophobia, etc;
- •adrenal tuberculosis;
- •suspected or diagnosed adrenocortical carcinoma;
- •unable to complete entire cognitive function tests;
- •current use of steroids or any drugs known to alter steroid synthesis or metabolism in the previous 3 months;
- •clinical Cushing syndrome;
- •Cushing disease;
- •primary hyperaldosteronism;
- •pheochromocytoma;
- •severe impairment of heart, liver, kidney and other organs;
- •pregnant and lactating women
结局指标
主要结局
Participants' personal information
时间窗: 1 day
Self-reported information(education in years)
Screening for adrenal cortisol hypersecretion
时间窗: 1 day
Patients were given 1 mg dexamethasone orally at 24:00 am, and the cortisol levels were measured at 8:00 am the following morning
Mini-Mental State Examination (MMSE)
时间窗: 20 minutes
The MMSE is a cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.
Rest Functional MRI of the brain function.
时间窗: 40 minutes
Rs-fMRI
Physical assessments
时间窗: 1 day
BMI(body mess index) in kg/m\^2
Montreal Cognitive Assessment (MoCA)
时间窗: 20 minutes
The MoCA is a Global cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.
Imaging examinations
时间窗: 1 day
Adrenal adenoma size in cm
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
时间窗: 1 hour
The RBANS is a cognitive screening test designed to assist Health Professionals in evaluation of multiple cognitive subdomains
次要结局
- Change from baseline Functional magnetic resonance imagine(12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)])
- Changes from basline global cognitive functions(12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)])
- Changes from basline multiple cognitive subdomains(12 months after the conservative treatment (for patients with autonomous cortisol secretion who are not willing to operate)])
研究者
Dalong Zhu
Chief Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School