- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06009250
Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut
August 22, 2023 updated by: Muhammad Ameen Abdelrady Abdelaziz
The goal of this observational study is to detect the prevalence of NAFLD in CKD patients
The main question[s] it aims to answer are:
- [question 1] prevalence of NAFLD in CKD patients.
- [question 2] the relationship between NAFLD and CKD.
Study Overview
Detailed Description
The goal of this observational study is to detect the prevalence of NAFLD in CKD patients
The main question[s] it aims to answer are:
- [question 1] prevalence of NAFLD in CKD patients.
- [question 2] the relationship between NAFLD and CKD.
Study Type
Observational
Enrollment (Estimated)
200
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
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
CKD patients
Description
Inclusion Criteria:
- CKD patients
Exclusion Criteria:
- HCV and HBV Positive patients
- Alcoholics
- patient on Hemodialysis
- patients with wilson disease
- patients with alpha one antitrypsin deficiency
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
Cohorts and Interventions
Group / Cohort |
---|
CKD patients
CKD patient who are not DM are investigated for the presence of NAFLD
|
normal control group
normal population are investigated to know the prevalence of NAFLD in contrast to patients with CKD.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
abdominal ultrasound
Time Frame: 1 year
|
assessment of Liver regarding fatty liver disease by Ultrasound.
|
1 year
|
liver enzymes
Time Frame: 1 year
|
participants will undergo assessment of liver enzymes (AST and ALT) and results will be reporeted in a table.
|
1 year
|
Fibroscan
Time Frame: 1 year
|
participants will undergo fibroscanning of the liver to assess NAFLD and results will be reported in a table.
|
1 year
|
BUN, Cr level and estimated GFR
Time Frame: 1 year
|
participants will be assessed regarding BUN, CR and estimated GFR to confirm and follow up CKD patients involved in the study.
|
1 year
|
Lipid Profile
Time Frame: 1 year
|
participants will be assessed regarding Cholesterol level, Triglycerides, HDL and LDL.
results will be reported in a table
|
1 year
|
Complete Blood Picture (WBCs, HB, Patelets
Time Frame: 1 year
|
total leucocytic count Hemoglobin level and platelet count will be assessed in our patients and will be reported in a table
|
1 year
|
serum Uric Acid
Time Frame: 1 year
|
serum uric acid will be assessed and reported in our patients
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Waist Circumference
Time Frame: 1 year
|
waist circumference measurement.
|
1 year
|
Body Mass Index
Time Frame: 1 year
|
BMI will also be calculated.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Estimated)
December 1, 2023
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
July 28, 2023
First Submitted That Met QC Criteria
August 22, 2023
First Posted (Actual)
August 24, 2023
Study Record Updates
Last Update Posted (Actual)
August 24, 2023
Last Update Submitted That Met QC Criteria
August 22, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Liver Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Fatty Liver
- Non-alcoholic Fatty Liver Disease
Other Study ID Numbers
- NAFLD and CKD
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.
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