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临床试验/NCT04946786
NCT04946786Unknown不适用

Role of Clinical, Biochemical and Body Composition Analysis in Assessment of Steatosis in Patients With Non Alcoholic Fatty Liver Disease

Sohag University0 个研究点目标入组 80 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
主要终点
measurement of steatosis by fibroscan examination

研究概览

简要总结

Non-alcoholic fatty liver disease (NAFLD) includes a spectrum of liver disorders characterized by accumulation of hepatic fat in absence of significant alcohol consumption (<20 gm/day) and other causes of liver diseases. It is the most common cause of asymptomatic elevation of liver enzymes worldwide (Marchesini et al., 2003).

Unfortunately, to date, existing non- or minimally invasive biomarkers are inadequate. While a number of non- or minimally invasive tests are able to rule out fibrosis or cirrhosis, no single test to identify steatosis, to early diagnose NASH, or to predict the disease progression is available. Moreover, specialized, combined tests are required to assess treatment response in clinical trials on emerging compounds (Piazzolla and Mangia, 2020).

Among minimally invasive tools, plasma biomarkers and composite scores defined as "wet biomarkers" are commonly used. For example, fasting insulin level and its use in measurement of insulin resistance, Lipid Accumulation Product (LAP) score (Bedogni et al., 2010), the NAFLD Liver Fat Score (NLFS) (Kontronen et al., 2009), Hepatic Steatosis Index (HSI) (Lee et al., 2010), controlled attenuation parameter (CAP) measurement by fibroscan (Piazzolla and Mangia, 2020). Recent studies have shown that CAP significantly correlates with the percentage of steatosis and steatosis grade and that median CAP is higher among patients with significant steatosis (Sasso et al., 2012 & Karlas et al., 2017).

The prevalence of NAFLD is 80-90% in obese, 30-50% in patients with diabetes and up to 90% in patients with hyperlipidemia (Abenavoli et al., 2014)

Central obesity or visceral fat (VF) (determined by waist circumference (WC)) is defined as the presence of excess fat in the abdomen, and this type of obesity is often associated with the development and progression of NAFLD or more advanced forms of liver disease (Abenavoli et al., 2016). Thus, measurement of body composition rather than BMI may be helpful in the prediction of NAFLD (Milić et al., 2014 and Abenavoli et al., 2016)

There is a growing need to assess the steatosis in NAFLD patients using minimally invasive tools.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

measurement of steatosis by fibroscan examination

时间窗: 2 years

Fibroscan examination measuring control attenuation parameter "CAP score"

body fat percentage.

时间窗: 2 years

measurement of body fat percentage

measuring serum cholesterol

时间窗: 2 years.

measuring serum cholesterol by mg/ dl.

measuring serum triglycerides.

时间窗: 2 years.

measuring serum triglycerides by mg/ dl.

studying anthropometric measurements of NAFLD cases.

时间窗: 2 years

-study anthropometric measurements.

body muscle percentage

时间窗: 2 years

measurement of body muscle percentage

measurement of body water percentage.

时间窗: 2 years

measurement of body water percentage.

measuring serum insulin level.

时间窗: 2 years.

measuring of serum insulin level using ELISA kits

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wafaa Gamal Mohamed

priciple investigator

Sohag University

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