NCT05521529招募中不适用
Effects of CORtisol Excess and REmission in Cushing's Syndrome Over Time (CORRECT): A Prospective Non-interventional Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in CushingQoL-score
研究概览
简要总结
The purpose of this study is to prospectively study patients with Cushing's syndrome before and after treatment, with a special emphasis on physical function, quality of life, and circadian rhythms.
The hypotheses are:
- Cushing's syndrome negatively impacts health-related quality of life (HRQoL) and physical functioning
- Cushing's syndrome is associated with altered circadian rhythms at the whole body level and in peripheral target tissues.
- These complications partially reverse following disease control.
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
- •New (≤ 2 months) diagnosis of Cushing's syndrome (CS) of endogenous etiology:
- •ACTH-dependent CS
- •ACTH-independent CS
- •Age >18 years
- •Written informed consent
排除标准
- •Active cancer
- •Iatrogenic or malignant cause of CS such as adrenocortical carcinoma
- •Chronic heart failure (New York Heart Association class IV)
- •Chronic kidney disease Chronic Kidney Disease stage ≥3 (eGFR >30 ml/min)
- •Liver disease in the form of cirrhosis
- •Deemed unable to complete the study safely by investigator
结局指标
主要结局
Change in CushingQoL-score
时间窗: Baseline, 3 months after and 1 year after treatment
Questionnaire filled out by patients
次要结局
- Change in Insulin resistance(Baseline, 3 months after and 1 year)
- Change in Vertebral Fracture Assessment(Baseline, 3 months after and 1 year)
- Change in total physical activity(Baseline, 3 months after and 1 year)
- Change in 24 hour urinary adreneric metabolites(Baseline, 3 months after and 1 year)
- Change in 24 hour urinary free cortisol(Baseline, 3 months after and 1 year)
- Change in Hba1C(Baseline, 3 months after and 1 year)
- Change in Messenger RNA expression of core clock genes in blood leukocytes and biopsies of skeletal muscle and adipose tissue.(Baseline, 3 months after and 1 year)
- Change in total sleep time(Baseline, 3 months after and 1 year)
- Change in Bone Mineral Density(Baseline, 3 months after and 1 year)
- Change in weight(Baseline, 3 months after and 1 year)
- Change in Sedentary time(Baseline, 3 months after and 1 year)
- Change in IPAQ-S7S(Baseline, 3 months after and 1 year)
- Change in blood pressure(Baseline, 3 months after and 1 year)
- Change in Hospital Anxiety and Depression Scale (HADS) score(Baseline, 3 months after and 1 year after treatment)
- Change in arterial stiffness and endothelial function.(Baseline, 3 months after and 1 year)
- Change in endothelial function.(Baseline, 3 months after and 1 year)
- Change in body composition(Baseline, 3 months after and 1 year)
- Change in BMI(Baseline, 3 months after and 1 year)
- Change in Timed up and go (TUG)-test(Baseline, 3 months after and 1 year)
- Change in Single item Sleep Quality Scale (SQS) score(Baseline, 3 months after and 1 year)
- Change in hip circumference(Baseline, 3 months after and 1 year)
- Change in waist circumference(Baseline, 3 months after and 1 year)
- Change in Short Physical Performance Battery (SPPB) and chair rising test - score(Baseline, 3 months after and 1 year)
- Change in Handgrip strength(Baseline, 3 months after and 1 year)
- FACS of blood leukocytes(Baseline, 3 months after and 1 year)
- Change in 24 hour urinary steroid metabolome(Baseline, 3 months after and 1 year)
研究者
研究点 (1)
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