Relation Between Carotid Atheroscerosis With DM &Fatty Liver

Not yet recruiting

• Conditions: Atherosclerosis With Diabetes Mellitus and Fatty Liver
• Interventions: Device: Carotid Doppler U/S

• Registration Number: NCT05532553
• Lead Sponsor: Assiut University

Brief Summary

To determine the risk of atherosclerosis in NAFLD patients who have T2DM by meauring Carotid intima media thickness (CIMT) using carotid doppler ultrasound.

Detailed Description

Fatty liver is one of the most common chronic liver diseases in the world. It's prevalence is reported to be 10-40% in the adult populations. At least 57% to 80% of them are associated with diabetes (1.2).Atherosclerosis and cardiovascular diseases are also highly prevalent in this group of patients(10).

Non-alcoholic fatty liver disease ( NAFLD) is characterized pathophysiological by hepatic fat accumulation independent of excessive alcohol use(3.4). Fatty liver index (FLI) has been demonstrated good diagnostic accuracy in different populations(6.7)...FLI will be based on BMI, waist circumference (WC), triacylglycerols (TG) and g-glutamyl transferase (GGT).

The individuals with NAFLD have a higher risk of 10-year cardiovascular events than healthy individuals.(10) .NAFLD and T2DM are common conditions that regularly co-exist and can act synergistically to drive adverse outcomes(5). Diabetic macrovascular complications are the major chronic complications and the leading cause of death among the patients with T2DM, of which the pathological basis is atherosclerosis.(8) Atherosclerosis usually starts in the vascular intima, progressing to the medial arterial wall(9).Carotid intima-media thickness (CIMT) is an indicator of the risk of vascular disease. Increased CIMT and presence of atherosclerotic plaque are considered as a reliable ultrasound biomarker of subclinical atherosclerosis and can be used for cardiovascular risk assessment\[9\].

In this study the investigators have the aim of evaluating the possible association between non-invasive index of fatty liver (FLI) and the presence of carotid atherosclerosis in T2DM.

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-01
• Study First Submitted: 2022-09-05
• Study First Submitted QC: 2022-09-05
• Last Update Submitted: 2022-09-07
• Study First Posted: 2022-09-08
• Last Update Posted: 2022-09-10
• Primary Completion: 2023-09-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients with fatty liver (diabetic& not diabetic).

Exclusion Criteria

• 1-Other causes of Liver disease ( (viral hepatitis, drug-induced liver disease, hepatolenticular degeneration, autoimmune liver disease, schistosomiasis liver disease, cirrhosis, etc.) 2- Heavy smoker.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Carotid Doppler U/S	patients with fatty liver only ( control group).
Group 1	Carotid Doppler U/S	Patient with T2DM and fatty liver.

Primary Outcome Measures

Name	Time	Method
Assessment of carotid atherosclerosis	baseline	To determine the risk of atherosclerosis in NAFLD patients who have T2DM by measuring CIMT using carotid doppler ultrasound.