Assessment of Renal Changes in Patients With Non Alcoholic Fatty Liver Disease

Not Applicable

• Conditions: Non-Alcoholic Fatty Liver Disease; Chronic Kidney Diseases
• Interventions: Device: The FibroScan device

• Registration Number: NCT03487068
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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 Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-03
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-04
• Study Start: 2018-04-30
• Primary Completion: 2019-04-30
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Patients diagnosed as NAFLD by abdominal ultrasonography, Fibroscan, NAFLD fibrosis score and FIB-4 score

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with NAFLD	The FibroScan device	-

Primary Outcome Measures

Name	Time	Method
Assessment of renal changes in patients with non-alcoholic fatty liver disease	baseline	Measuring renal changes especially glomerular and interstitial pathologies which will lead to chronic kidney disease in patients with non alcoholic fatty liver disease.