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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 22, 2018
    Last Updated
    April 3, 2018
    Sponsor
    Assiut University
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    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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