NCT03487068Unknown不适用
Assessment of Renal Changes in Patients With Non Alcoholic Fatty Liver Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Assessment of renal changes in patients with non-alcoholic fatty liver disease
研究概览
简要总结
Assess the renal changes in patients with non-alcoholic fatty liver (NAFLD).
详细描述
- Non-alcoholic fatty liver disease (NAFLD) is the accumulation of fat (>5%) in liver cells in the absence of excessive alcohol intake or other causes of liver disease. The histologic spectrum of NAFLD ranges from simple steatosis to non-alcoholic steatohepatitis (NASH), liver fibrosis, and cirrhosis. This disease affects up to 30% of the general population in Western countries, especially in patients with metabolic syndrome, obesity, and type II diabetes.
- Accumulating epidemiologic evidence indicates that NAFLD not only affects the liver but also increases the risk of extra-hepatic diseases such as type 2 diabetes mellitus, metabolic syndrome, hypertension, cardiovascular or cerebrovascular diseases, and chronic kidney disease.
- Chronic kidney disease (CKD) is defined by decreased estimated glomerular filtration rate (eGFR) and/or the presence of significant proteinuria. Its prevalence is ~ 4.3 - 13% in general population, but it is expected to increase and ~ 50% of these patients develop end-stage renal disease. Recently, CKD is significantly higher in patients with NAFLD than patients without.
- Several studies have demonstrated that NAFLD independently contributes to increasing the risk of CKD where NAFLD and CKD may share many common cardio-metabolic risk factors e.g. insulin resistance, chronic inflammation, and obesity.
- The exact pathophysiologic mechanisms linking NAFLD to CKD are not completely understood, however, there is increased production of various proinflammatory cytokines, reactive oxygen species, TNF-α, C-reactive protein (CRP), and IL-6 by hepatocytes and non-parenchymal cells (Kupffer cells and hepatic stellate cells) that can link NAFLD and CKD. In addition, altered rennin-angiotensin system activation can be involved.
- Several western studies had evaluated the relationship between NAFLD and CKD and shown the prevalence of CKD in NAFLD patients between 4 - 40%.
- An analysis of the United Network Organ Sharing (UNOS) data base during the years (2002-2011) revealed that 35% of the patients transplanted for NAFLD-related cirrhosis progressed to stage 3-4 CKD within 2 years after liver transplantation in comparison to 10% of patients transplanted for other etiologies.
- Despite these findings CKDs often goes unrecognized and The Third National Health and Nutrition survey (NHANESIII), among all individuals with moderately decreased GFR (less than 60ml/min; stage 3) reported the awareness was approximately 8%.
- There is still very little prospective studies and data linking NAFLD to CKD, and it is lacking in the middle east region.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as NAFLD by abdominal ultrasonography, Fibroscan, NAFLD fibrosis score and FIB-4 score
排除标准
- •Patients with diabetes and/or hypertension.
- •Patients with chronic renal disease.
- •Patients with urinary tract infections.
- •Patients on medications affecting the kidney (eg: NSAIDs,..etc)
- •Patients with chronic liver disease other than NAFLD (chronic hepatitis; viral B,C, autoimmune etc).
- •Alcohol consumption.
研究组 & 干预措施
Patients with NAFLD
Other
干预措施: The FibroScan device (Device)
结局指标
主要结局
Assessment of renal changes in patients with non-alcoholic fatty liver disease
时间窗: baseline
Measuring renal changes especially glomerular and interstitial pathologies which will lead to chronic kidney disease in patients with non alcoholic fatty liver disease.
次要结局
未报告次要终点
研究者
Maiada Mohie Eldin Ibrahim
Resident Doctor Of Gastroenterology
Assiut University
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