Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT04779905
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2021-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chronic Kidney Disease and Non-alcoholic Fatty Liver Diseases
Sponsor:
Sohag University
Organization:
Study Overview
Official Title:
Assessment of Chronic Kidney Disease in Non Alcoholic Fatty Liver Disease(NAFLD) Patients
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAFLD
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: