Risk of CKD in Diabetic Patients With MAFLD

NCT06304844 | Not Yet Recruiting DMC

• 1 other identifier: Soh-Med-24-02-06MD
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

diabetic without MAFLD

patients with type 2 DM but has no evidence of MAFLD

diabetic with MAFLD (high hepatic involvement)

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

Diagnostic Test: transient elastography (Fibroscan)

diabetic with MAFLD (low hepatic involvement)

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

Diagnostic Test: transient elastography (Fibroscan)

Interventions

transient elastography (Fibroscan) DIAGNOSTIC_TEST

conduct fibroscan for patients with (MAFLD by abdominal ultrasonography)

diabetic with MAFLD (high hepatic involvement); diabetic with MAFLD (low hepatic involvement)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population for this study comprises individuals diagnosed with type 2 diabetes mellitus either with or without MAFLD. The MAFLD group will encompass individuals meeting standardized diagnostic criteria for MAFLD and having a confirmed diagnosis of type 2 diabetes. Participants with comorbidities, such as viral hepatitis, cirrhosis, and cancers, will be excluded to ensure a focused study population. The chosen sample size of 300 individuals will allow for a robust examination of the prevalence of chronic kidney disease and associated risk factors within this specific cohort.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Ahmed Ismail, ass. lecturer

CONTACT

00201019472026; ahmed.zayed@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer - internal medicine department

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: April 20, 2024
• Primary Completion: October 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share