Risk of CKD in Diabetic Patients With MAFLD

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Diagnostic Test: transient elastography (Fibroscan)

• Registration Number: NCT06304844
• Lead Sponsor: Sohag University

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-12
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Study Start: 2024-04-20
• Primary Completion: 2024-10-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
diabetic with MAFLD (low hepatic involvement)	transient elastography (Fibroscan)	patients with type 2 DM and have evidence of MAFLD (according to abdominal ultrasonography) and have low controlled attenuation parameter and liver stffiness measurement in Fibroscan
diabetic with MAFLD (high hepatic involvement)	transient elastography (Fibroscan)	patients with type 2 DM and have evidence of MAFLD (according to abdominal ultrasonography) and have high controlled attenuation parameter and liver stiffness measurement in Fibroscan

Primary Outcome Measures

Name	Time	Method
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	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)