Risk of CKD in Diabetic Patients With MAFLD

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06304844
• Other study ID #: Soh-Med-24-02-06MD
• Status: Not yet recruiting
• Start date: April 20, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: March 2024
• Source: Sohag University
• Contact: Ahmed Ismail, ass. lecturer
• Phone: 00201019472026
• Email: ahmed.zayed[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: February 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Diagnostic Test:
• transient elastography (Fibroscan)
conduct fibroscan for patients with (MAFLD by abdominal ultrasonography)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	utilizing standardized diagnostic criteria for CKD including estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (UACR)	6 months from the start of participants recruitment