跳至主要内容
临床试验/NCT05881005
NCT05881005招募中不适用

Prévalence de la stéato-fibrose hépatique Dans le Syndrome de Cushing

University Hospital, Angers12 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月28日最近更新:
适应症
干预措施

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

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

Other

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)

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (12)

Loading locations...

相似试验