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Association Betweenq MAFLD ( Metabolic Associated Fatty Liver Disease) and Chronic Kidney Disease

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06135467
Collaborator
(none)
150
Enrollment
7.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Assess frequency of renal affection in mafld

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Metabolic dysfunction-associated fatty liver disease (MAFLD) is a multisystem disorder, but its relationship with kidney injury remains controversial. This study aimed to evaluate MAFLD effects on the chronic kidney disease (CKD) frequency The association between metabolic dysfunction associated fatty liver disease (MAFlD) and extrahepatic disease is not known .the aim of this cross sectional study is to compare the frequency of CKD in patients with MAFLD and examine association between presence and severity of MAFLD and CKD and abnormal albuminuria.

    Non-alcoholic fatty liver disease (NAFLD) is characterized by the accumulation of fat in more than 5% of hepatocytes in the absence of excessive alcohol consumption and other secondary causes of hepatic steatosis. In 2020, the more inclusive term metabolic (dysfunction)-associated fatty liver disease (MAFLD) - defined by broader diagnostic criteria

    • was proposed to replace the term NAFLD. The new terminology and revised definition better emphasize the pathogenic role of metabolic dysfunction and uses a set of definitive, inclusive criteria for diagnosis. Diagnosis of MAFLD is based on evidence of hepatic steatosis (as assessed by liver biopsy, imaging techniques or blood biomarkers and scores) in persons who are overweight or obese and have type 2 diabetes mellitus or metabolic dysregulation, regardless of the coexistence of other liver diseases or excessive alcohol consumption.

    The known association between NAFLD and chronic kidney disease (CKD) and our understanding that CKD can occur as a consequence of metabolic dysfunction suggests that individuals with MAFLD - who by definition have fatty liver and metabolic comorbidities - are at increased risk of CKD.

    MAFLD appears to be tightly linked to incident chronic kidney disease (CKD). This association may be attributed to multiple shared risk factors including type 2 diabetes mellitus, arterial hypertension, obesity, dyslipidemia, and insulin resistance Diagnostic criteria of MAFLD are ( steatosis with one of the following

    1. BMI >25

    2. type II DM

    3. 2 metabolic abnormalities [ 1)waist circumferance >94 in males or 80 in females 2)bp

    130/85 3) plasma triglycrides > 150 mg / dl 4) HDL < 40 5)prediabetes 6) HOMA insulin resistance score >2.5 7)plasma hs CRP> 2 mg/dl ]

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Association Between MAFLD ( Metabolic Associated Fatty Liver Disease) and Chronic Kidney Disease
    Anticipated Study Start Date :
    Apr 14, 2025
    Anticipated Primary Completion Date :
    Nov 14, 2025
    Anticipated Study Completion Date :
    Nov 15, 2025

    Outcome Measures

    Primary Outcome Measures

    1. the frequency of MAFLD in CKD patients 2_To screen early MAFLD in CKD patients 3_To association between MAFLD in CKD and type II DM patients [Baseline]

      estimate the frequency of MAFLD in CKD patients 2_To screen early MAFLD in CKD patients 3_To association between MAFLD in CKD and type II DM patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. CKD patients type II . III and type IV not on dialysis

    2. Patients with MAFLD

    3. patients with type II DM

    Exclusion Criteria:

    1. Patients with AKI

    2. patients with NAFLD

    3. patients with alcoholic fatty liver disease

    4. patients with type I DM

    5. malignancy

    6. HBV HCV

    7. autoimmune disease

    8. liver cirrhosis

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marwa adel shehata, Doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06135467
    Other Study ID Numbers:
    • Mafld in ckd patients
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 18, 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
    Kidney Diseases
    Renal Insufficiency, Chronic

    Study Results

    No Results Posted as of Nov 18, 2023