Clinical trial NCT04779905: Chronic Kidney Disease and Non-alcoholic Fatty Liver Diseases
Official title: Assessment of Chronic Kidney Disease in Non Alcoholic Fatty Liver Disease(NAFLD) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
NAFLD
Keywords: chronic kidney disease
NAFLD
Hepatic fibrosis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: prevalence of chronic kidney disease in nafld patient
timeFrame: February 2021 to July 2021
measure: correlation of chronic kidney disease and degree of hepatic fibrosis in nafld patient
timeFrame: February 2021 to July 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Mona Mohammed Abdelrahman
Study officials:
affiliation: Sohag University
name: Radwa Farag, MD
role: STUDY_CHAIR
affiliation: Sohag University
name: Mohamed Amin, MD
role: STUDY_CHAIR
affiliation: Sohag University
name: Shimaa Hemdan, MD
role: STUDY_CHAIR
References:
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.
citation: 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. No abstract available.
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.
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.