Clinical trial NCT06157125: Assessment of the Association Between Metabolic Associated Fatty Liver Disease (MFLD) and Biopsy Proved Cases of GN
Official title: Assessment of the Association Between Metabolic Associated Fatty Liver Disease MFLD and Glomerulonephritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Assessment of Patients With Biopsy Proven Primary Glomerulonephritis Above 18 Years of Age for MFLD Development
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Patients with biopsy proven primary glomerulonephritis.
* Age \>18 years

Exclusion Criteria:

1. Patients with e-GFR\<60ml/min/1.73m2
2. Patients with secondary glomerulonephritis
3. Patients with body mass index \>35 kg/m2
4. Patients known to be diabetic.
5. Patients known to be hypertensive.
6. Patients with HCV or HBV infection either acute or chronic
7. Patients with acute hepatitis whatever the aetiology
8. Patients with autoimmune diseases

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Patients with biopsy proven primary glomerulonephritis.
* Age \>18 years

Exclusion Criteria:

1. Patients with e-GFR\<60ml/min/1.73m2
2. Patients with secondary glomerulonephritis
3. Patients with body mass index \>35 kg/m2
4. Patients known to be diabetic.
5. Patients known to be hypertensive.
6. Patients with HCV or HBV infection either acute or chronic
7. Patients with acute hepatitis whatever the aetiology
8. Patients with autoimmune diseases

Primary outcomes:
measure: Assessment of the association between MFLD and GN
timeFrame: Within 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Assiut university hospitals nephrology department
city: Asyut
country: Egypt
facility: Assiut university hospitals nephrology department
Study officials:
References:
citation: 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.
citation: 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.
citation: Marcuccilli M, Chonchol M. NAFLD and Chronic Kidney Disease. Int J Mol Sci. 2016 Apr 14;17(4):562. doi: 10.3390/ijms17040562.
citation: 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.