Chronic Kidney Disease and Non-alcoholic Fatty Liver Diseases (NAFLD)

November 1, 2021 updated by: Mona Mohammed Abdelrhman, Sohag University

Assessment of Chronic Kidney Disease in Non Alcoholic Fatty Liver Disease(NAFLD) Patients

Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease worldwide. This disease reportedly affects up to 30% of the general population in Western countries, especially in patients with metabolic syndrome, obesity, and type II diabetes. NAFLD is considered to be an independent risk factor for cardiovascular disease and there is accumulating evidence to support a causative role in the development of chronic kidney disease (CKD). So, we aim first to assess the prevalence of chronic kidney disease in NAFLD patients, secondly to detect the association between hepatic fibrosis and CKD in NAFLD patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted on 100 patients 70 patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital, and A control group of 30 healthy volunteers who looks normal on ultrasonography from February 2021 to July 2021.

Methods:

All included patients will be subjected to:

  1. Detailed history, complete general and systemic examination .
  2. BMI will be calculated as follow
  3. Abdominal Ultrasonography.

  4. Laboratory investigations:

    Fasting and post-prandial blood sugar Serum lipogram. Liver function tests. Serum creatinine, Albumin -creatinine Ratio.

  5. Calculation of estimated Glomerular Filtration Rate eGFR.
  6. Liver stiffness measurements to detect degree of fibrosis and measurement of the degree of steatosis using (Fibroscan)

Ethical considerations:

The study will be approved by The Ethical committee of Sohag Faculty of Medicine, Sohag University.

The study protocol will be adherent to practice guidelines of the World Medical Association Code of Ethics (Declaration of Helsinki).

After explanation about the nature of the procedures, possible complications, benefits, and steps of the study, All patients will give a written informed consent for participating in the study, performing abdominal ultrasound, taking blood samples, performing fibroscan.

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

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

Study Locations

  • Egypt
      • Sohag, Egypt
        • Mona Mohammed Abdelrahman

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study will be conducted on 100 patients 70 patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital, and A control group of 30 healthy volunteers who looks normal on ultrasonography from February 2021 to July 2021

Description

Inclusion Criteria:

patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital

Exclusion Criteria:

  1. Diabetic patients.
  2. Hypertensive patients.
  3. Other causes of chronic liver disease rather than NAFLD.

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-alcoholic Fatty Liver Diseases
patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital
Diagnostic test: urinary albumbin/creatinine ratio
detection of microalbuminuria in nafld patients
Other Names:
  • estimated glomerular filtration rate
control
healthy volunteers who looks normal on ultrasonography
Diagnostic test: urinary albumbin/creatinine ratio
detection of microalbuminuria in nafld patients
Other Names:
  • estimated glomerular filtration rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence of chronic kidney disease in nafld patient
Time Frame: February 2021 to July 2021
February 2021 to July 2021
correlation of chronic kidney disease and degree of hepatic fibrosis in nafld patient
Time Frame: February 2021 to July 2021
February 2021 to July 2021

Collaborators and Investigators

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

Sponsor

Sohag University

Investigators

  • Study Chair: Radwa Farag, MD, Sohag University
  • Study Chair: Mohamed Amin, MD, Sohag University
  • Study Chair: Shimaa Hemdan, MD, Sohag 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 (Actual)

February 28, 2021

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

September 15, 2021

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

November 2, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-02-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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 Chronic Kidney Diseases

Clinical Trials on urinary albumbin/creatinine ratio

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe