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Clinical Trial Summary

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.


Clinical Trial Description

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.

Moreover, Yassui k documented the presence of moderately decreased eGFR and high frequency of micro-albuminuria in patients with biopsy proven NASH.

The diagnosis of NAFLD/NASH is based on the gold standard of liver biopsy or less reliably on serum liver enzymes or ultrasound imaging. However, liver biopsy has its limitations: apart from being an invasive procedure, connected with serious complications .

Many non-invasive procedures have been intensively applied to detect hepatic steatosis and fibrosis. The Controlled Attenuation Parameter (CAP) can using transient elastography (TE) (Fibroscan®) permits to efficiently separate different grades of severity of steatosis. CAP is based on the properties of ultrasonic signals acquired by the Fibroscan®. It allows to simultaneously measure liver stiffness and CAP in the same liver volume.

The volume used for the measurement by the Fibroscan® is 200 times larger than that of a liver biopsy specimen. Therefore the Fibroscan® is used more and more in clinical practice .

Many biochemical markers can be used for diagnosis of NAFLD such as tissue inhibitor of metalloproteinase 1 (TIMP1), aminoterminal peptide of procollagen III (P3NP) .

Up till now, the relationship between NAFLD and CKD is still poorly understood and under discussed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04482153
Study type Observational
Source Assiut University
Contact marwa ahmed, resident doctor
Phone 01140291416
Email marwa011398@med.au.edu.eg
Status Not yet recruiting
Phase
Start date July 2020
Completion date July 2021