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

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ClinicalTrials.gov Identifier: NCT04779905

Recruitment Status : Completed

First Posted : March 3, 2021

Last Update Posted : November 2, 2021

Sponsor:

Information provided by (Responsible Party):

Mona Mohammed Abdelrhman, Sohag University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Chronic Kidney Diseases NAFLD	Diagnostic Test: urinary albumbin/creatinine ratio

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:

Detailed history, complete general and systemic examination .
BMI will be calculated as follow
Abdominal Ultrasonography.
Laboratory investigations:

Fasting and post-prandial blood sugar Serum lipogram. Liver function tests. Serum creatinine, Albumin -creatinine Ratio.
Calculation of estimated Glomerular Filtration Rate eGFR.
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 Design

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Study Type :	Observational
Actual Enrollment :	62 participants
Observational Model:	Case-Control
Time Perspective:	Cross-Sectional
Official Title:	Assessment of Chronic Kidney Disease in Non Alcoholic Fatty Liver Disease(NAFLD) Patients
Actual Study Start Date :	February 28, 2021
Actual Primary Completion Date :	July 30, 2021
Actual Study Completion Date :	September 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Non-alcoholic fatty liver disease

MedlinePlus related topics: Fatty Liver Disease Kidney Diseases Liver Diseases

Genetic and Rare Diseases Information Center resources: Visceral Steatosis

U.S. FDA Resources

Groups and Cohorts

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 Name: 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 Name: estimated glomerular filtration rate

Outcome Measures

Primary Outcome Measures :

prevalence of chronic kidney disease in nafld patient [ Time Frame: 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Sampling Method:	Probability Sample

Study Population

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04779905

Locations

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Egypt
Mona Mohammed Abdelrahman
Sohag, Egypt

Sponsors and Collaborators

Sohag University

Investigators

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Study Chair:	Radwa Farag, MD	Sohag University
Study Chair:	Mohamed Amin, MD	Sohag University
Study Chair:	Shimaa Hemdan, MD	Sohag University

More Information

Publications:

Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011 Aug;34(3):274-85. doi: 10.1111/j.1365-2036.2011.04724.x. Epub 2011 May 30. Review.

Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762.

Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17. Review.

McCullough K, Sharma P, Ali T, Khan I, Smith WC, MacLeod A, Black C. Measuring the population burden of chronic kidney disease: a systematic literature review of the estimated prevalence of impaired kidney function. Nephrol Dial Transplant. 2012 May;27(5):1812-21. doi: 10.1093/ndt/gfr547. Epub 2011 Sep 29. Review.

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Responsible Party:	Mona Mohammed Abdelrhman, Principal investigator, Sohag University
ClinicalTrials.gov Identifier:	NCT04779905
Other Study ID Numbers:	Soh-Med-21-02-40
First Posted:	March 3, 2021 Key Record Dates
Last Update Posted:	November 2, 2021
Last Verified:	November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Mona Mohammed Abdelrhman, Sohag University:


chronic kidney disease NAFLD Hepatic fibrosis

Additional relevant MeSH terms:

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Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Kidney Diseases	Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency Digestive System Diseases

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