Screening for Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD) at Al-Rajhy Hospital Nutrition Clinic
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 主要终点
- Screen for MAFLD among patients attending to the Nutrition clinic in Al Rajhi hospital
研究概览
简要总结
Primary outcome Screen for MAFLD among patients attending to the Nutrition clinic in Al Rajhi hospital.
Secondary outcome
- Determining the degrees of fibrosis and steatosis in patients with MAFLD
- Determining the rate of obesity, diabetes mellitus (DM), hypertension (HTN), hyperlipidemia in patients with MAFLD.
- Determining the rate of patients with other associated chronic liver disease (CLD).
详细描述
Metabolic dysfunction-associated fatty liver disease (MAFLD) formly called non alcoholic fatty liver disease (NAFLD) was defined as the presence of macrovesicular steatosis in ≥5% of hepatocytes in individuals who consume little or no alcohol. NAFLD was divided into two major subtypes: nonalcoholic fatty liver, and Non alcoholic steatohepatitis (NASH).
It is now believed that MAFLD is due to state of systemic metabolic dysfunction and is perceived as standalone disease that warrants positive diagnosis rather than simply a disease of exclusion. MAFLD affects about quarter of the world's population and it is now considered a public health issue.
Real time ultrasound (US) scanning is accepted as the first line imaging investigation in patients with suspected liver disorders. In spite insufficient sensitivity to detect liver inflammation and fibrosis, it demonstrates a good correlation with histological finding of fatty infiltration.
Another tool used for detection of fatty liver is fatty liver index (FLI) which is an algorithm based on waist circumference, body mass index (BMI), triglyceride, and gamma-glutamyl-transferase (GGT). A FLI < 30 (negative likelihood ratio = 0.2) rules out and a FLI ≥ 60 (positive likelihood ratio = 4.3) rules in fatty liver. FLI had an accuracy of 0.84 (95% confidence interval (CI) 0.81-0.87) in detecting fatty liver.
Haung X, et al, 2015 found that FLI achieves a high sensitivity of 79.89% and a specificity of 71.51% for diagnosis of NAFLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-80 years
排除标准
- •Pregnant females.
- •Patients who will refuse to participate in the study.
结局指标
主要结局
Screen for MAFLD among patients attending to the Nutrition clinic in Al Rajhi hospital
时间窗: baseline
Screening will be done according to new criteria set by Eslam M, et al, 2020, Patients with detected fatty liver by ultrasound will undergo an evaluation for the BMI and fasting and post prandial blood glucose levels. Patients with with BMI \>25 kg/m2 or type two diabetes mellitus (DM) will be diagnosed to have MAFLD. Patients with BMI \< 25 kg/m2 and normal sugar curve will be subjected to tests to detect metabolic abnormalities with the presence of at least two metabolic risk abnormalities, the subject will be diagnosed as MAFLD. Eventually the percentage of patients diagnosed as MAFLD will be calculated among this random sample
次要结局
- Determining the rate of obesity, DM, HTN, hyperlipidemia in patients with MAFLD(baseline)
- determining the number of patients diagnosed as MAFLD and degree of fibrosis and steatosis in each one.(baseline)
- Determining the rate of patients with other associated chronic liver disease(CLD)(baseline)
研究者
Yusuf Salah-eldin Amry Ahmad
Resident
Assiut University