Chronic Kidney Disease and Non-alcoholic Fatty Liver Diseases

Chronic Kidney Diseases Clinical Trial

— NAFLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779905
• Other study ID #: Soh-Med-21-02-40
• Status: Completed
• Start date: February 28, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: November 2021
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 15, 2021
• Est. primary completion date: July 30, 2021
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Fatty Liver
• Kidney Diseases
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• urinary albumbin/creatinine ratio
detection of microalbuminuria in nafld patients

Locations

Country	Name	City	State
Egypt	Mona Mohammed Abdelrahman	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of chronic kidney disease in nafld patient		February 2021 to July 2021
Primary	correlation of chronic kidney disease and degree of hepatic fibrosis in nafld patient		February 2021 to July 2021