Assessment of the Association Between Metabolic Associated Fatty Liver Disease (MFLD) and Biopsy Proved Cases of GN (MFLD)
November 27, 2023 updated by: Randa Abd Elkader Anwar, Assiut University
Assessment of the Association Between Metabolic Associated Fatty Liver Disease MFLD and Glomerulonephritis
Fatty liver disease is a global health concern with a prevalence of about 25% amongst United States.
Its increased prevalence is attributed to increase in patients with obesity and metabolic syndrome (1).
Diabetes mellitus (DM),obesity, hyperinsulinemia are predisposing factors for fatty liver disease(2).
Glomerulonephritis (GN), a complex syndrome encompassing a variety of individual disorders, is associated with significant morbidity and mortality(3).
Given its association with hyperlipidaemia, metabolic syndrome and long-term use of steroid there is concern that patients with GN may be at increased risk of fatty liver disease Patients with NS are frequently found to have fatty liver disease even when adjusting for common risk factors(1).
It is known that obesity is an independent risk factor for CKD and it is associated with the development of proteinuria and pathologic findings of podocyte hypertrophy and focal segmental glomerular sclerosis even in the absence of diabetes and hypertension .
In addition, studies have shown that obesity as well as metabolic syndrome is a strong predictor of the development of fatty liver disease (4) .
Hence, clinicians should maintain a high index of suspicion regarding presence of NAFLD in patients with NS
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
100
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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Asyut, Egypt, 71515
- Recruiting
- Assiut university hospitals nephrology department
-
Contact:
- Assiut university
- Phone Number: 0020882411900
- Email: med@aun.edu.eg
-
Asyut, Egypt, 71515
- Active, not recruiting
- Assiut university hospitals nephrology department
-
-
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
No
Sampling Method
Non-Probability Sample
Study Population
Inclusion Criteria:
- Patients with biopsy proven primary glomerulonephritis.
- Age >18 years
Exclusion Criteria:
- Patients with e-GFR<60ml/min/1.73m2
- Patients with secondary glomerulonephritis
- Patients with body mass index >35 kg/m2
- Patients known to be diabetic.
- Patients known to be hypertensive.
- Patients with HCV or HBV infection either acute or chronic
- Patients with acute hepatitis whatever the aetiology
- Patients with autoimmune diseases
Description
Inclusion Criteria:
- Patients with biopsy proven primary glomerulonephritis.
- Age >18 years
Exclusion Criteria:
- Patients with e-GFR<60ml/min/1.73m2
- Patients with secondary glomerulonephritis
- Patients with body mass index >35 kg/m2
- Patients known to be diabetic.
- Patients known to be hypertensive.
- Patients with HCV or HBV infection either acute or chronic
- Patients with acute hepatitis whatever the aetiology
- Patients with autoimmune diseases
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of the association between MFLD and GN
Time Frame: Within 1 year
|
Assessment of the association between MFLD and GN
|
Within 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Amarapurkar D, Kamani P, Patel N, Gupte P, Kumar P, Agal S, Baijal R, Lala S, Chaudhary D, Deshpande A. Prevalence of non-alcoholic fatty liver disease: population based study. Ann Hepatol. 2007 Jul-Sep;6(3):161-3.
- Wetmore JB, Guo H, Liu J, Collins AJ, Gilbertson DT. The incidence, prevalence, and outcomes of glomerulonephritis derived from a large retrospective analysis. Kidney Int. 2016 Oct;90(4):853-60. doi: 10.1016/j.kint.2016.04.026. Epub 2016 Jul 15.
- Marcuccilli M, Chonchol M. NAFLD and Chronic Kidney Disease. Int J Mol Sci. 2016 Apr 14;17(4):562. doi: 10.3390/ijms17040562.
- Onwuzo SS, Hitawala AA, Boustany A, Kumar P, Almomani A, Onwuzo C, Monteiro JM, Asaad I. Prevalence of non-alcoholic fatty liver disease in patients with nephrotic syndrome: A population-based study. World J Hepatol. 2023 Feb 27;15(2):265-273. doi: 10.4254/wjh.v15.i2.265.
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)
June 1, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
November 27, 2023
First Submitted That Met QC Criteria
November 27, 2023
First Posted (Estimated)
December 5, 2023
Study Record Updates
Last Update Posted (Estimated)
December 5, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MFLD and GN
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.