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Assessment of the Association Between Metabolic Associated Fatty Liver Disease (MFLD) and Biopsy Proved Cases of GN

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06157125
Collaborator
(none)
100
Enrollment
2
Locations
13
Anticipated Duration (Months)
50
Patients Per Site
3.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessment of the Association Between Metabolic Associated Fatty Liver Disease MFLD and Glomerulonephritis
    Anticipated Study Start Date :
    Jun 1, 2024
    Anticipated Primary Completion Date :
    Jun 1, 2025
    Anticipated Study Completion Date :
    Jul 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of the association between MFLD and GN [Within 1 year]

      Assessment of the association between MFLD and GN

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university hospitals nephrology department Asyut Egypt 71515
    2 Assiut university hospitals nephrology department Asyut Egypt 71515

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Randa Abd Elkader Anwar, Randa Abd Elkader Anwar, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06157125
    Other Study ID Numbers:
    • MFLD and GN
    First Posted:
    Dec 5, 2023
    Last Update Posted:
    Dec 5, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Diseases
    Fatty Liver
    Glomerulonephritis

    Study Results

    No Results Posted as of Dec 5, 2023