Identification of New Biomarkers in the Diagnosis and Prognosis of Non-alcoholic Fatty Liver Disease and Correlation With Ultrasound and Elastographic Findings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- soluble biomarkers of liver fibrosis
研究概览
简要总结
Fibrosis is considered the leading cause of liver diseases and related mortality. Specifically, hepatic fibrosis is regarded as the consequence of reparative mechanisms initiated by hepatocytes in response to chronic damage. In Western countries, the main known etiologies include hepatitis (B and C), alcoholism, and non-alcoholic steatohepatitis (NASH). In particular, obesity is a determining factor in the onset and development of NASH. Alarming statistical data indicate that over 30% of the world's population is obese, and this eating disorder is increasingly affecting young people. NASH is a chronic disease that can present different degrees of fibrosis and, as the final stage, lead to the development of liver cirrhosis. Currently, the only accurate diagnostic and assessment system for this condition is liver biopsy, as there are no accurate non-invasive clinical tests available. The aim of this project is to identify (in silico) potential biomarkers involved in the development and progression of hepatic fibrosis and validate their presence and quantity in serum or plasma samples from obese patients (at-risk population). This would avoid the need for a liver biopsy and allow "at-risk" patients to undergo a simple ambulatory blood draw. Additionally, performing elastometry of the liver would allow for comparison of radiological results with laboratory findings.
详细描述
Project Description:
In modern society, with the advent of industrial development, lifestyle has been greatly modified, leading to unhealthy habits such as overeating and fast food consumption (following an unbalanced diet rich in sugars and fats) and reduced physical activity. In the European Union, over half of adults are overweight or obese. This group of individuals is considered at high risk for the development of chronic liver diseases such as non-alcoholic fatty liver disease (NAFLD). Many epidemiological reports have linked the onset of NAFLD to poor dietary choices and sedentary habits. Currently, there are no effective pharmacological therapies, and the only way to prevent or improve the condition is by leading a healthier lifestyle (personalized diets, physical activity, and cognitive-behavioral psychological therapies). The main limitation to this solution is the lack of patient adaptability to the therapy.
NAFLD encompasses a wide histological spectrum ranging from simple steatosis to non-alcoholic steatohepatitis (NASH). NASH is characterized by steatosis with inflammation and can present different stages of fibrosis, from absent to cirrhosis. The gold standard for diagnosis and evaluation of fibrosis stage remains liver biopsy. However, performing a liver biopsy for every suspected NAFLD patient is impossible, both for ethical reasons and because it is not a valid screening method. Therefore, it is necessary to develop non-invasive methods for screening and diagnosis. Furthermore, early diagnosis could increase patient awareness of their chronic disease and motivate them to change their lifestyle.
Considering this, it is therefore necessary to develop non-invasive methods for screening and diagnosis. Furthermore, early diagnosis could increase the patient's awareness of their chronic condition and convince them to change their lifestyle.
It should be considered that identifying new markers can be a very challenging task due to:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI> 35 Eligible for bariatric surgery according to the current international guidelines (IFSO guidelines)
排除标准
- •Patients affected by active liver viral infection
- •Patient alcohol or drug addicted
- •Incompetent patients
结局指标
主要结局
soluble biomarkers of liver fibrosis
时间窗: Time of enrollment. At baseline, before collecting liver biopsy during bariatric surgery
To identify (through in silico analysis) and validate new biomarkers that are useful for the diagnosis and prognosis of NAFLD, which can be used in non-invasive clinical tests.
次要结局
- Biobank(At baseline and at the time of bariatric surgery)
- Follow-up(6 -12 months after surgery)
- Correlation analysis(At baseline and 12 months after surgery)
研究者
Silvia Palmisano
Associate professor
University of Trieste