Assessment of Renal Changes in Patients With Non Alcoholic Fatty Liver Disease
Primary Purpose
Non-Alcoholic Fatty Liver Disease, Chronic Kidney Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The FibroScan device
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with NAFLD
Arm Description
Outcomes
Primary Outcome Measures
Assessment of renal changes in patients with non-alcoholic fatty liver disease
Measuring renal changes especially glomerular and interstitial pathologies which will lead to chronic kidney disease in patients with non alcoholic fatty liver disease.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03487068
Brief Title
Assessment of Renal Changes in Patients With Non Alcoholic Fatty Liver Disease
Official Title
Assessment of Renal Changes in Patients With Non Alcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2018 (Anticipated)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
May 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Chronic Kidney Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with NAFLD
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
The FibroScan device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of renal changes in patients with non-alcoholic fatty liver disease
Description
Measuring renal changes especially glomerular and interstitial pathologies which will lead to chronic kidney disease in patients with non alcoholic fatty liver disease.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maiada M Ibrahim, Master
Phone
01068388643
Email
maiada145@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed El Taher, PHD
Phone
01005602251
Email
Mohamedeltaheribrahim@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29427494
Citation
Castera L. Diagnosis of non-alcoholic fatty liver disease/non-alcoholic steatohepatitis: Non-invasive tests are enough. Liver Int. 2018 Feb;38 Suppl 1:67-70. doi: 10.1111/liv.13658.
Results Reference
background
PubMed Identifier
28870674
Citation
Sinn DH, Kang D, Jang HR, Gu S, Cho SJ, Paik SW, Ryu S, Chang Y, Lazo M, Guallar E, Cho J, Gwak GY. Development of chronic kidney disease in patients with non-alcoholic fatty liver disease: A cohort study. J Hepatol. 2017 Dec;67(6):1274-1280. doi: 10.1016/j.jhep.2017.08.024. Epub 2017 Sep 20.
Results Reference
background
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Assessment of Renal Changes in Patients With Non Alcoholic Fatty Liver Disease
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