The Significance of Remnant Cholesterol and Carotid Intima Media Thickness in Patients With MAFLD (MAFLD)

1. To detect the significance of remenant cholesterol in detection severity of MAFLD
2. To detect the significance of carotid intima-media thickness in MAFLD

Study Overview

• Status: Recruiting
• Conditions: Detect the Significance of Remnant Cholesterol in Detection Severity of MAFLD
• Intervention / Treatment: Diagnostic test: Lipid profile

Detailed Description

Non-alcoholic fatty liver disease (NAFLD) is fatty infiltration of the liver in the absence of other causes of steatosis, such as alcohol consumption characterized by excessive fat accumulation in liver >5-10% of its weight encompassing a spectrum of increasingly severe clinico-pathological conditions - nonalcoholic fatty liver (NAFL) and nonalcoholic steato-hepatitis (NASH) with or without fibrosis/cirrhosis. Since NAFLD is frequently associated with further metabolic comorbidities such as obesity, type 2 diabetes mellitus, or dyslipidemia, it is generally considered as the hepatic manifestation of the metabolic syndrome A growing body of evidence also indicates that NAFLD is strongly associated with an increased risk of major CVD events and other cardiac complications (ie, cardiomyopathy, cardiac valvular calcification and cardiac arrhythmias), independently of traditional cardiovascular risk factors NAFLD has also been associated with an increase in the carotid intima- media thickness (CIMT), independent of conventional CVD risk factors. CIMT is a marker of early atherosclerosis and has been shown to predict increased risks of myocardial in-farction and stroke Fatty liver index (FLI) has been proposed as an accurate, convenient, and economic surrogate of the severity of NAFLD. Remnant cholesterol refers to the cholesterol content carried by triglyceride-rich lipoproteins, which include non-LDL-C and nonhigh density lipoprotein-cholesterol (HDL-C) A large number of studies have reported that serum remnant cholesterol levels were positively associated with the risk of coronary artery disease NAFLD

, type 2 diabetes , and metabolic syndrome

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Ahmed Kh Nazier; Phone Number: 01005897058; Email: ak0555012@gmail.com
• Study Contact Backup: Name: Marwa Mo Mahmoud; Phone Number: 01000580208; Email: marwaabokresha@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The study will include patients presented to Fibroscan clinic, Internal medicine department at Assiut University hospitals within 1 year

Description

Inclusion Criteria:

• The study will include adult patients (≥18 years) presented to fibroscan clinic and diagnosed as MAFLD.

Exclusion Criteria:

1. Patients Known previous cardiac disease ( cardiovascular disease, heart failure, arrhythmia )
2. Patients Known liver cirrhosis
3. septic patients
4. Patients have malignancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To detect the significance of remnant cholesterol in detection severity of MAFLD	lipid profile in MAFLD patients to detect remnant cholesterol	From Jan 2025 to Jan 2026
To detect the relationship between carotid intima-media thickness and remnant cholesterol in MAFLD and prediction of cardiovascular effect.	color doppler and echocardiography in MAFLD patients	From Jan 2025 to Jan 2026

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Severity of MAFLD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No