Evolution of the Metabolic, Cardiovascular, Bone Complications and of the Quality of Life in Cushing's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- number of complications (hormonal and imaging results, quality of life) per patient (composite)
研究概览
简要总结
This study aims at investigating the complications of Cushing's disease in "de novo" patients. A series of investigations will assay before treatment and every year thereafter during a 3 years follow-up period the various complications of the disease. These investigations will determine the presence and severity of cardiovascular, metabolic, and bone complications as well as the Quality of Life. Outcome of these complications after treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.
详细描述
At inclusion the following will be investigated and recorded :
- demographic and personal medical history.
- Familial medical history related to osteoporosis, cardiovascular disorders and thromboembolism.
- Current medical treatment.
- Physical examination.
- Assessment of basal 24hrs urinary cortisol and salivary cortisol.
- At baseline (i.e. before specific treatment of Cortisol excess):
- physical examination,
- routine biology,
- HbA1C, fasting glucose and oral glucose load,
- cholesterol, triglyceride, HDL & LDL,
- coagulation and fibrinolysis investigation,
- 24hrs urinary cortisol and salivary cortisol, urinary labstick test.
- EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US,
- ophthalmology examination,
- spine X-Ray, bone densitometry,
- QoL questionnaires (SF-36, QoLCushing, Beck BDI-II).
Every year during a 3 years follow-up the following will be investigated :
- Current medical treatment.
- Physical examination.
- Assessment of basal routine biology,
- HbA1C, fasting glucose,
- cholesterol, triglyceride, HDL & LDL,
- coagulation and fibrinolysis investigation,
- 24hrs urinary cortisol and salivary cortisol, urinary labstick test.
- EKG, cardiac ultrasound, cardiac CT-scan (if abnormal initially), arterial and venous US,
- ophthalmology examination, bone densitometry,
- QoL questionnaires (SF-36, QoLCushing, Beck BDI-II).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cushing's disease diagnosed by complementary explorations according to the National Program of Diagnosis and Care of the Cushing 's disease
排除标准
- •other cause of Cushing's syndrome
- •known inherited syndrome having for consequence an hormonal hypersecretion (NEM-1, complexe of carney, McCuneAlbright syndrome)
- •patient does not understand french
- •life expectancy of less than 6 months
- •pregnant women
- •dependent patient
结局指标
主要结局
number of complications (hormonal and imaging results, quality of life) per patient (composite)
时间窗: from diagnosis until 3 years of treatment
Evaluate the frequency of : * metabolic complications (HbA1C, fasting glucose and oral glucose load, cholesterol, triglyceride, HDL \& LDL, coagulation and fibrinolysis investigation, 24hrs urinary cortisol and salivary cortisol, urinary labstick test) * cardiovascular thromboembolic complications (EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US) * bone complications (spine X-Ray, bone densitometry) * quality of life alteration measured by questionnaires (SF36, QoLCushing, Beck BDI-II)
次要结局
- Remission rate of Cushing's disease(1 year after treatment)