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Clinical Trial Summary

Assess the renal changes in patients with non-alcoholic fatty liver (NAFLD).


Clinical Trial Description

- 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03487068
Study type Interventional
Source Assiut University
Contact Maiada M Ibrahim, Master
Phone 01068388643
Email maiada145@yahoo.com
Status Not yet recruiting
Phase N/A
Start date April 30, 2018
Completion date May 30, 2019

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