CKDNCT06009250
Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut
An observational study of CKD and NAFLD, run by Muhammad Ameen Abdelrady Abdelaziz.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: CKD patients
Who may be able to join
- CKD patients
Who cannot join
- HCV and HBV Positive patients
- Alcoholics
- patient on Hemodialysis
- patients with wilson disease
- patients with alpha one antitrypsin deficiency
About this study
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.
Read the 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.
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
abdominal ultrasound
assessment of Liver regarding fatty liver disease by Ultrasound.
Measured: 1 year
liver enzymes
participants will undergo assessment of liver enzymes (AST and ALT) and results will be reporeted in a table.
Measured: 1 year
Fibroscan
participants will undergo fibroscanning of the liver to assess NAFLD and results will be reported in a table.
Measured: 1 year
BUN, Cr level and estimated GFR
participants will be assessed regarding BUN, CR and estimated GFR to confirm and follow up CKD patients involved in the study.
Measured: 1 year
Lipid Profile
participants will be assessed regarding Cholesterol level, Triglycerides, HDL and LDL. results will be reported in a table
Measured: 1 year
Complete Blood Picture (WBCs, HB, Patelets
total leucocytic count Hemoglobin level and platelet count will be assessed in our patients and will be reported in a table
Measured: 1 year
serum Uric Acid
serum uric acid will be assessed and reported in our patients
Measured: 1 year
Secondary outcomes (2)
Waist Circumference
waist circumference measurement.
Measured: 1 year
Body Mass Index
BMI will also be calculated.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad Ameen Abdelrady Abdelaziz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Ameen Abdelrady Abdelaziz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009250
- Sponsor's protocol ID
- NAFLD and CKD
- Status last verified
- Aug 2023
- First submitted
- 28 Jul 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut
- ClinicalTrials.gov ID
- NCT06009250
- Acronym / sponsor ID
- NAFLD and CKD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Muhammad Ameen Abdelrady AbdelazizUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- CKD patients
Key inclusion criteria (1 listed)
- CKD patients
Key exclusion criteria (5 listed)
- HCV and HBV Positive patients
- Alcoholics
- patient on Hemodialysis
- patients with wilson disease
- patients with alpha one antitrypsin deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
abdominal ultrasound
Time frame: 1 year
assessment of Liver regarding fatty liver disease by Ultrasound.
liver enzymes
Time frame: 1 year
participants will undergo assessment of liver enzymes (AST and ALT) and results will be reporeted in a table.
Fibroscan
Time frame: 1 year
participants will undergo fibroscanning of the liver to assess NAFLD and results will be reported in a table.
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.
Lipid Profile
Time frame: 1 year
participants will be assessed regarding Cholesterol level, Triglycerides, HDL and LDL. results will be reported in a table
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
serum Uric Acid
Time frame: 1 year
serum uric acid will be assessed and reported in our patients
2 secondary outcomes
Waist Circumference
Time frame: 1 year
Body Mass Index
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD and NAFLD, run by Muhammad Ameen Abdelrady Abdelaziz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abdominal ultrasound (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.