Chronic Kidney Disease and Non-alcoholic Fatty Liver Diseases (NAFLD)
November 1, 2021 updated by: Mona Mohammed Abdelrhman, Sohag University
Assessment of Chronic Kidney Disease in Non Alcoholic Fatty Liver Disease(NAFLD) Patients
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
62
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sohag, Egypt
- Mona Mohammed Abdelrahman
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
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
|
detection of microalbuminuria in nafld patients
Other Names:
|
|
control
healthy volunteers who looks normal on ultrasonography
|
detection of microalbuminuria in nafld patients
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
prevalence of chronic kidney disease in nafld patient
Time Frame: February 2021 to July 2021
|
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
|
February 2021 to July 2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Radwa Farag, MD, Sohag University
- Study Chair: Mohamed Amin, MD, Sohag University
- Study Chair: Shimaa Hemdan, MD, Sohag University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2021
Primary Completion (Actual)
July 30, 2021
Study Completion (Actual)
September 15, 2021
Study Registration Dates
First Submitted
February 26, 2021
First Submitted That Met QC Criteria
February 26, 2021
First Posted (Actual)
March 3, 2021
Study Record Updates
Last Update Posted (Actual)
November 2, 2021
Last Update Submitted That Met QC Criteria
November 1, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-21-02-40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.