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临床试验/NCT04482153
NCT04482153Unknown不适用

Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut University Hospitals

Assiut University0 个研究点目标入组 80 人开始时间: 2020年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
主要终点
Evaluation of the relationship between the severity of fatty liver in NAFLD assessed by liver enzymes, biochemical markers, ultrasonography and grades of Fibroscan with CKD staging, eGFR and proteinuria.

研究概览

简要总结

The aim of our study is:

  1. The early detection of NAFLD in CKD patients with different stages (stage I to IV) to avoid progression to liver fibrosis.
  2. Evaluation of the relationship between the severity of fatty liver in NAFLD assessed by liver enzymes, biochemical markers, ultrasonography and grades of Fibroscan with CKD staging, eGFR and proteinuria.

详细描述

Chronic kidney disease (CKD) is defined as presence of reduced glomerular filtration rate (GFR) < 60 ml/min/ 1.73 m2 and/or evidence of kidney damage (usually indicated by albuminuria or proteinuria) for > 3 months or more irrespective of cause . CKD stages are classified according to the National Kidney Foundation in to five stages according to estimated GFR .

The prevalence of CKD is continuously rising in concert with the rising epidemic of its risk factors including ageing, diabetes, obesity, metabolic syndrome, smoking, and hypertension .

Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases in Western countries. It encompasses a spectrum of conditions with lipid deposition in hepatocytes, ranging from simple steatosis to non-alcoholic steatohepatitis (NASH).

It is defined as fatty liver with inflammation and hepatocelullar injury with or without fibrosis, advanced fibrosis and cirrhosis. Metabolic syndrome with its clinical traits is highly prevalent in patients with NAFLD .

Preliminary data suggest an association between CKD and NAFLD .reported that the prevalence of CKD was significantly higher in patients with NASH compared to patients without NASH.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

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

入选标准

  • Eighty CKD patients with different stages (stage I to IV) according to the National Kidney Foundation are recruited from inpatients of renal unit in internal medicine department, Assuit university hospitals. Their GFR will assessed by using CKD EPI equation measured as GFR=166 x(s cr/0.7)-1.209X(0.993)age if female, and GFR=163X(s cr/0.9)-1.209x(0.993)age if male. (Andrews et al 2009).
  • CKD staging according to GFR by CKD EPI is:
  • Stage1 in which GFR>90 mil/min but evidence of kidney damage.
  • Stage 2 GFR 60-89 mil/min.
  • Stage 3 GFR 30-95 mil/min.
  • Stage 4 GFR 15-29 mil/min.
  • Stage 5 GFR<15 mil/min. The patients will be enrolled from October 2020 to October 2021.

排除标准

  • 1- All Patients with positive hepatitis C virus antibodies. 2- All Patients with positive hepatitis B surface antigen. 3- Congested liver. 4- Drug induced hepatosteatosis (INH, estrogens, methotrexate, steroids, amiodarone, etc.).
  • 5- Autoimmune liver diseases. 6- Metabolic liver diseases. 7- Alcoholic liver disease. 8- Malignancy. 9- ESRD (stage V) on hemodialysis. 10- Obesity overweight BMI >
  • 11- Metabolic syndrome. 12- Type II DM.

结局指标

主要结局

Evaluation of the relationship between the severity of fatty liver in NAFLD assessed by liver enzymes, biochemical markers, ultrasonography and grades of Fibroscan with CKD staging, eGFR and proteinuria.

时间窗: 1year

Evaluation of the relationship between the severity of fatty liver in NAFLD assessed by liver enzymes, biochemical markers, ultrasonography and grades of Fibroscan with CKD staging, eGFR and proteinuria.

The early detection of NAFLD in CKD patients with different stages (stage I to IV) to avoid progression to liver fibrosis.

时间窗: 1 year

The early detection of NAFLD in CKD patients with different stages (stage I to IV) to avoid progression to liver fibrosis.

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

Marwa Ahmed

Principal investigator

Assiut University

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