Prévalence de la stéato-fibrose hépatique Dans le Syndrome de Cushing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Frequency of resolution of hepatic steatosis
研究概览
简要总结
Cushing's Syndrome is a rare disease resulting from prolonged exposure to high levels of circulating cortisol. Clinical manifestations are variable but many patients present a metabolic syndrome (abdominal obesity, insulin resistance, dyslipidemia, hypertension). With regard to the liver, experimental data have shown that excess cortisol leads in an increase in lipogenesis and a reduction in the oxidation of fatty acids. This, in association with an accumulation of visceral adipose tissue and deregulation of adipokines, may contribute to the development of hepatic steatosis in animals. However, few data is available in humans with only one study of 50 patients with Cushing's syndrome estimating the prevalence of hepatic steatosis at 20%.
NAFLD (Non-Alcoholic Fatty Liver Disease), is defined as the presence of hepatic steatosis in the absence of secondary causes of intrahepatic fat accumulation. It is a heterogeneous disease ranging from simple liver steatosis, whose prognosis is generally considered to be benign, to inflammation (NASH, Non-Alcoholic Steato-Hepatitis) which may progress to fibrosis, cirrhosis and an increased risk of hepatocellular carcinoma. The prognosis for NAFLD is mainly related to the severity of hepatic fibrosis.
In Cushing's syndrome, normalization of cortisol production is the most effective strategy to improve co-morbidities associated with hypercortisolism. However, some of these complications, especially the metabolic co morbidities, could not be completely reversible and no data is available about resolution of hepatic steatosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age > 18 years
- •Active Cushing's syndrome
排除标准
- •Other common causes of chronic liver disease (HBV, HCV, haemochromatosis, alcohol)
- •Contraindication to MRI
研究组 & 干预措施
open-label study
hepatic MRI, Fibroscan
干预措施: hepatic MRI (Diagnostic Test)
结局指标
主要结局
Frequency of resolution of hepatic steatosis
时间窗: 2 years
To evaluate the frequency of complete resolution of hepatic steatosis in patients with cushing syndrome after remission of hypercortisolism
次要结局
- e-LIFT (non-invasive biomarkers advanced hepatic fibrosis)(2 years)
- FIB-4 (non-invasive biomarkers advanced hepatic fibrosis)(2 years)
- Fatty Liver Index (non-invasive biomarkers of hepatic steatosis )(2 years)
- NAFLD Fibrosis Score (non-invasive biomarkers advanced hepatic fibrosis)(2 years)
- Prevalence of steatosis at diagnosis of Cushing(2 years)
