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

November 12, 2023 updated by: Marwa adel shehata, Assiut University

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

Assess frequency of renal affection in mafld

Study Overview

Status

Not yet recruiting

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 Type

Observational

Enrollment (Estimated)

150

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

  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 ].

And divided into 3 groups :

  1. MAFLD with type II DM
  2. MAFLD not type II DM
  3. control group

Description

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

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
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
Time Frame: 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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

April 14, 2025

Primary Completion (Estimated)

November 14, 2025

Study Completion (Estimated)

November 15, 2025

Study Registration Dates

First Submitted

November 12, 2023

First Submitted That Met QC Criteria

November 12, 2023

First Posted (Estimated)

November 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

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.

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