A Multicenter, Retrospective Clinical Study on the Clinical Characteristics of Metabolic Associated Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Clinical characteristics and follow-up outcomes of MAFLD patients
研究概览
简要总结
Metabolic associated fatty liver disease (MAFLD), which can lead to liver fibrosis, cirrhosis, liver failure and even hepatocellular carcinoma, poses a significant burden on society. With the improvement of living standards and changes in dietary habits, MAFLD patients show a younger and increasing trend, but there is still no specific drug. The clinical features and prognosis of MAFLD may be different with different metabolic disorder phenotypes and treatment measures. Therefore, further systematic study of the clinical characteristics and prognosis of MAFLD patients will be of great significance for the formulation of corresponding clinical prevention and treatment strategies.
详细描述
Metabolic associated fatty liver disease (MAFLD), which can lead to liver fibrosis, cirrhosis, liver failure and even hepatocellular carcinoma, poses a significant burden on society. With the improvement of living standards and changes in dietary habits, MAFLD patients show a younger and increasing trend, but there is still no specific drug. The clinical features and prognosis of MAFLD may be different with different metabolic disorder phenotypes and treatment measures. Therefore, further systematic study of the clinical characteristics and prognosis of MAFLD patients will be of great significance for the formulation of corresponding clinical prevention and treatment strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •18 years or older;
- •MAFLD patients
排除标准
- •malignant tumors;
- •mental illness, severe impairment of cardiopulmonary function, severe renal insufficiency, severe infections, and cerebrovascular accidents;
- •received liver or other organ transplants.
结局指标
主要结局
Clinical characteristics and follow-up outcomes of MAFLD patients
时间窗: 480 weeks
1. Clinical characteristic related indicators: height (m), weight (kg), waist circumference (cm), previous history (T2DM, HT, dyslipidemia), SBP (mmHg), DBP (mmHg), alcohol intake (g/week), smoking, blood routine \[WBC (109/L), Hb (g/L), PLT (109/L)\], CRP (mg/L), biochemical indicators \[TB (umol/L), ALB (g/L), ALT (U/L), AST (U/L), ALP (U/L), GGT (U/L), TC (mmol/L), TG (mmol/L), HDL (mmol/L), LDL (mmol/L)\], blood glucose indicators \[FBG (mmol/L), PBG (mmol/L), HA1c (%)\], coagulation \[PT (s), INR\], AFP (ng/ml), transient elastography \[LSM (Kpa), ACP (dB/m)\], liver CT/MRI/B type ultrasound. 2. Follow up outcome data: mortality and causes of death, incidence of complications (ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, intrahepatic and extrahepatic malignancies, infection, cardiovascular and cerebrovascular diseases, or all-cause mortality).
次要结局
- Risk factors for progression to cirrhosis and hepatocellular carcinoma(480 weeks)
- Clinical characteristics and follow-up outcomes of MAFLD patients under different subgroups(480 weeks)
- Baseline clinical characteristics MAFLD patients(0 weeks)
研究者
Jie Li
Principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School