Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut University Hospitals

July 20, 2020 updated by: Marwa Ahmed, Assiut University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eighty CKD patients with different stages (stage I to IV) according to the National Kidney Foundation are recruited from inpatients of renal unit in internal medicine department, Assuit university hospitals. Their GFR will assessed by using CKD EPI

Description

Inclusion Criteria:

- Eighty CKD patients with different stages (stage I to IV) according to the National Kidney Foundation are recruited from inpatients of renal unit in internal medicine department, Assuit university hospitals. Their GFR will assessed by using CKD EPI equation measured as GFR=166 x(s cr/0.7)-1.209X(0.993)age if female, and GFR=163X(s cr/0.9)-1.209x(0.993)age if male. (Andrews et al 2009).

CKD staging according to GFR by CKD EPI is:

  • Stage1 in which GFR>90 mil/min but evidence of kidney damage.
  • Stage 2 GFR 60-89 mil/min.
  • Stage 3 GFR 30-95 mil/min.
  • Stage 4 GFR 15-29 mil/min.
  • Stage 5 GFR<15 mil/min. The patients will be enrolled from October 2020 to October 2021.

Exclusion Criteria:

  • 1- All Patients with positive hepatitis C virus antibodies. 2- All Patients with positive hepatitis B surface antigen. 3- Congested liver. 4- Drug induced hepatosteatosis (INH, estrogens, methotrexate, steroids, amiodarone, etc.).

    5- Autoimmune liver diseases. 6- Metabolic liver diseases. 7- Alcoholic liver disease. 8- Malignancy. 9- ESRD (stage V) on hemodialysis. 10- Obesity overweight BMI > 30. 11- Metabolic syndrome. 12- Type II DM.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The early detection of NAFLD in CKD patients with different stages (stage I to IV) to avoid progression to liver fibrosis.
Time Frame: 1 year
The early detection of NAFLD in CKD patients with different stages (stage I to IV) to avoid progression to liver fibrosis.
1 year
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.
Time Frame: 1year
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.
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAFLD inCKD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Study of the NAFLD in CKD Patients Using Fibroscan Study

Clinical Trials on fibroscan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe