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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03487068
Enrollment
50
Registered
2018-04-03
Start date
2018-04-30
Completion date
2019-05-30
Last updated
2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Non-Alcoholic Fatty Liver Disease

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.

Interventions

DEVICEThe FibroScan device

The Fibroscan device (Echosens) works by measuring shear wave velocity. In this technique, a 50-MHz wave is passed into the liver from a small transducer on the end of an ultrasound probe. The probe also has a transducer on the end that can measure the velocity of the shear wave (in meters per second) as this wave passes through the liver. The shear wave velocity can then be converted into liver stiffness, which is expressed in kilopascals. Essentially, the technology measures the velocity of the sound wave passing through the liver and then converts that measurement into a liver stiffness measurement; the entire process is often referred to as liver ultrasonographic elastography.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of renal changes in patients with non-alcoholic fatty liver diseasebaselineMeasuring renal changes especially glomerular and interstitial pathologies which will lead to chronic kidney disease in patients with non alcoholic fatty liver disease.

Contacts

Primary ContactMaiada M Ibrahim, Master
maiada145@yahoo.com01068388643
Backup ContactMohamed El Taher, PHD
Mohamedeltaheribrahim@yahoo.com01005602251

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026