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Risk of CKD in Diabetic Patients With MAFLD

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06304844
Enrollment
300
Registered
2024-03-12
Start date
2024-04-20
Completion date
2025-02-01
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

conduct fibroscan for patients with (MAFLD by abdominal ultrasonography)

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 MAFLD6 months from the start of participants recruitmentutilizing standardized diagnostic criteria for CKD including estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (UACR)

Contacts

Primary ContactAhmed Ismail, ass. lecturer
ahmed.zayed@med.sohag.edu.eg00201019472026

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026