Chronic Kidney Disease and Non-alcoholic Fatty Liver Diseases

Completed

• Conditions: Chronic Kidney Diseases; NAFLD
• Interventions: Diagnostic Test: urinary albumbin/creatinine ratio

• Registration Number: NCT04779905
• Lead Sponsor: Sohag University

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.

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Study Start: 2021-02-28
• Study First Posted: 2021-03-03
• Primary Completion: 2021-07-30
• Study Completion: 2021-09-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-alcoholic Fatty Liver Diseases	urinary albumbin/creatinine ratio	patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital
control	urinary albumbin/creatinine ratio	healthy volunteers who looks normal on ultrasonography

Primary Outcome Measures

Name	Time	Method
prevalence of chronic kidney disease in nafld patient	February 2021 to July 2021
correlation of chronic kidney disease and degree of hepatic fibrosis in nafld patient	February 2021 to July 2021

Trial Locations

Locations (1)

Mona Mohammed Abdelrahman; 🇪🇬 Sohag, Egypt