Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT06135467
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2023-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association Betweenq MAFLD ( Metabolic Associated Fatty Liver Disease) and Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-12', 'studyFirstSubmitDate': '2023-11-12', 'studyFirstSubmitQcDate': '2023-11-12', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': 'Baseline', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mafld in Ckd Patients']}, 'descriptionModule': {'briefSummary': 'Assess frequency of renal affection in mafld', 'detailedDescription': '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.\n\nNon-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.\n\nThe 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.\n\nMAFLD 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\n\n1. BMI \\>25\n2. type II DM\n3. \\> 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 \\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'the study is done on 150 patients diagnosed as MAFLD with its diagnostic criteria (Diagnostic criteria of MAFLD are ( steatosis with one of the following\n\n1. BMI \\>25\n2. type II DM\n3. \\> 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 \\].\n\nAnd divided into 3 groups :\n\n1. MAFLD with type II DM\n2. MAFLD not type II DM\n3. control group', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. CKD patients type II . III and type IV not on dialysis\n2. Patients with MAFLD\n3. patients with type II DM\n\nExclusion Criteria:\n\n1. Patients with AKI\n2. patients with NAFLD\n3. patients with alcoholic fatty liver disease\n4. patients with type I DM\n5. malignancy\n6. HBV HCV\n7. autoimmune disease\n8. liver cirrhosis'}, 'identificationModule': {'nctId': 'NCT06135467', 'briefTitle': 'Association Betweenq MAFLD ( Metabolic Associated Fatty Liver Disease) and Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Association Between MAFLD ( Metabolic Associated Fatty Liver Disease) and Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'Mafld in ckd patients'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Marwa adel shehata', 'investigatorAffiliation': 'Assiut University'}}}}