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Clinical Trials/NCT06304844
NCT06304844
Not yet recruiting
Not Applicable

Assessing the Risk of Chronic Kidney Disease Associated With Metabolic Dysfunction-Associated Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus

Sohag University0 sites300 target enrollmentApril 20, 2024
ConditionsType 2 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
Sohag University
Enrollment
300
Primary Endpoint
Determine the number of participant with eGFR<60 ml/min/1.73 m2 or albuminuria (urinary albumin-to-creatinine ratio (ACR) ⩾3 mg/mmol) in patients with type 2 DM and MAFLD
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

This cross-sectional study of 300 participants investigates the risk of chronic kidney disease (CKD) in individuals with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes. By evaluating hepatic measurements and metabolic markers, the study aims to identify key risk factors for CKD in this population, contributing valuable insights to inform targeted interventions.

Detailed Description

investigators plan to enroll 300 participants with type 2 DM to comprehensively investigate the risk of chronic kidney disease (CKD) in individuals diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes mellitus. In this study, the participant population will be grouped based on presence of MAFLD or not into 2 groups, then the group with MAFLD will be subdivided into subgroups based on the degree of hepatic involvement, considering both controlled attenuation parameter (CAP) values for steatosis and liver stiffness measurements for fibrosis via fibro scan device. This grouping strategy aims to categorize individuals into distinct cohorts, such as Low Hepatic Involvement and High Hepatic Involvement groups, facilitating a nuanced exploration of the association between hepatic conditions and the risk of chronic kidney disease (CKD) in the context of metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes mellitus.

Registry
clinicaltrials.gov
Start Date
April 20, 2024
End Date
February 1, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mahmoud Ismail

assistant lecturer - internal medicine department

Sohag University

Eligibility Criteria

Inclusion Criteria

  • Type 2 diabetic patients
  • Willing and agreed to be included in the study.

Exclusion Criteria

  • Type 1 diabetic patients or non-diabetic patients.
  • Patient with known glomerulonephritis.
  • Patient with diagnosis of or clinical features that are suspicious for another systemic disease that commonly causes kidney disease (e.g., connective tissue disorders, HIV).
  • Patient with evidence of alternative kidney disease like (Documented obstructive uropathy, etc.)
  • Patient with history of kidney transplantation.
  • Patient with end stage renal disease or on dialysis.
  • Patients with active malignancy.
  • Individuals with a history of hepatitis B surface antigen or hepatitis C antibody positivity.
  • history of excessive alcohol consumption (⩾30 g/day in men and ⩾20 g/day in women)
  • Decompensated liver cirrhosis.

Outcomes

Primary Outcomes

Determine the number of participant with eGFR<60 ml/min/1.73 m2 or albuminuria (urinary albumin-to-creatinine ratio (ACR) ⩾3 mg/mmol) in patients with type 2 DM and MAFLD

Time Frame: 6 months from the start of participants recruitment

utilizing standardized diagnostic criteria for CKD including estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (UACR)

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