Chronic Kidney DiseasesNAFLDNCT04779905
Chronic Kidney Disease and Non-alcoholic Fatty Liver Diseases
An observational study of Chronic Kidney Diseases and NAFLD, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases, NAFLD
- What is being tested?
- urinary albumbin/creatinine ratio
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2021to 15 Sep 2021
- 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 20 to 80 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital
Who cannot join
- Diabetic patients.
- Hypertensive patients.
- Other causes of chronic liver disease rather than NAFLD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Chronic Kidney Diseases, NAFLD
- Being tested
- urinary albumbin/creatinine ratio
- Keywords
- chronic kidney disease, NAFLD, Hepatic fibrosis
- Medical subject headings
- Renal Insufficiency, Chronic, Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary albumbin/creatinine ratioDiagnostic test
Also called estimated glomerular filtration rate
detection of microalbuminuria in nafld patients
| Study group | Role | What they receive |
|---|---|---|
| Non-alcoholic Fatty Liver Diseases | patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital Receives: Diagnostic Test: urinary albumbin/creatinine ratio | |
| control | healthy volunteers who looks normal on ultrasonography Receives: Diagnostic Test: urinary albumbin/creatinine ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of chronic kidney disease in nafld patient
Measured: February 2021 to July 2021
correlation of chronic kidney disease and degree of hepatic fibrosis in nafld patient
Measured: February 2021 to July 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start28 Feb 2021
- Primary completion30 Jul 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohammed Abdelrhman, Sohag University
- Investigators
- Radwa Farag, MD, Study chair, Sohag UniversityMohamed Amin, MD, Study chair, Sohag UniversityShimaa Hemdan, MD, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779905
- Sponsor's protocol ID
- Soh-Med-21-02-40
- Acronym
- NAFLD
- Status last verified
- Nov 2021
- First submitted
- 26 Feb 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21623852Chalasani 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.
PubMed 22488764Loomba 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.
PubMed 24042449McCullough 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.
PubMed 21965592
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Chronic Kidney Disease in Non Alcoholic Fatty Liver Disease(NAFLD) Patients
- ClinicalTrials.gov ID
- NCT04779905
- Acronym / sponsor ID
- NAFLD / Soh-Med-21-02-40
- Conditions
- Chronic Kidney Diseases, NAFLD
- Keywords
- chronic kidney disease, NAFLD, Hepatic fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 3 Mar 2021 (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.
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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-alcoholic Fatty Liver Diseases | – | Diagnostic Test: urinary albumbin/creatinine ratiopatients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital |
| control | – | Diagnostic Test: urinary albumbin/creatinine ratiohealthy volunteers who looks normal on ultrasonography |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital
Key exclusion criteria (3 listed)
- Diabetic patients.
- Hypertensive patients.
- Other causes of chronic liver disease rather than NAFLD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urinary albumbin/creatinine ratioAlso: estimated glomerular filtration ratedetection of microalbuminuria in nafld patients | Diagnostic test | Non-alcoholic Fatty Liver Diseases, control |
Primary outcome
prevalence of chronic kidney disease in nafld patient
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Background: PubMed 21623852Vernon 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.
- Background: PubMed 22488764Chalasani 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.
- Background: PubMed 24042449Loomba 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.
- Background: PubMed 21965592McCullough 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.
- Individual participant dataSharing planned: No
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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.
Radwa Farag, MD study chair
Sohag University
Mohamed Amin, MD study chair
Sohag University
Shimaa Hemdan, MD study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and NAFLD, run by Sohag University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
prevalence of chronic kidney disease in nafld patient (time frame: February 2021 to July 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04779905, which also lists 4 linked publications.
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 2 Nov 2021.