Clinical trial NCT05532553: Relation Between Carotid Atheroscerosis With DM &Fatty Liver
Official title: Association Between Carotid Atherosclerosis and Fatty Liver Index in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis With Diabetes Mellitus and Fatty Liver
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who will be presented to internal medicine department\& outpatient clinics at Assiut university hospital divided into 2 groups.

Group 1:Patient with T2DM and fatty liver. Group 2: patients with fatty liver only ( control group). Carotid doppler ultrasonography will be considered for both groups to measure Carotid Intima Media Thickness (CIMT).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of carotid atherosclerosis
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Walaa Anwar Mohamed Khalifa, Doctor
role: STUDY_DIRECTOR
References:
citation: Pereira K, Salsamendi J, Casillas J. The Global Nonalcoholic Fatty Liver Disease Epidemic: What a Radiologist Needs to Know. J Clin Imaging Sci. 2015 May 29;5:32. doi: 10.4103/2156-7514.157860. eCollection 2015.
citation: Younossi ZM. Non-alcoholic fatty liver disease - A global public health perspective. J Hepatol. 2019 Mar;70(3):531-544. doi: 10.1016/j.jhep.2018.10.033. Epub 2018 Nov 9.
citation: Benedict M, Zhang X. Non-alcoholic fatty liver disease: An expanded review. World J Hepatol. 2017 Jun 8;9(16):715-732. doi: 10.4254/wjh.v9.i16.715.
citation: Rinella ME, Sanyal AJ. NAFLD in 2014: Genetics, diagnostics and therapeutic advances in NAFLD. Nat Rev Gastroenterol Hepatol. 2015 Feb;12(2):65-6. doi: 10.1038/nrgastro.2014.232. Epub 2015 Jan 6.
citation: Hazlehurst JM, Woods C, Marjot T, Cobbold JF, Tomlinson JW. Non-alcoholic fatty liver disease and diabetes. Metabolism. 2016 Aug;65(8):1096-108. doi: 10.1016/j.metabol.2016.01.001. Epub 2016 Jan 11.
citation: Lee JH, Kim D, Kim HJ, Lee CH, Yang JI, Kim W, Kim YJ, Yoon JH, Cho SH, Sung MW, Lee HS. Hepatic steatosis index: a simple screening tool reflecting nonalcoholic fatty liver disease. Dig Liver Dis. 2010 Jul;42(7):503-8. doi: 10.1016/j.dld.2009.08.002. Epub 2009 Sep 18.
citation: Bedogni G, Bellentani S, Miglioli L, Masutti F, Passalacqua M, Castiglione A, Tiribelli C. The Fatty Liver Index: a simple and accurate predictor of hepatic steatosis in the general population. BMC Gastroenterol. 2006 Nov 2;6:33. doi: 10.1186/1471-230X-6-33.
citation: Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018 Feb;14(2):88-98. doi: 10.1038/nrendo.2017.151. Epub 2017 Dec 8.
citation: Stein JH, Tattersall MC. Carotid intima-media thickness and cardiovascular disease risk prediction. J Am Coll Cardiol. 2014 Jun 3;63(21):2301-2. doi: 10.1016/j.jacc.2014.02.528. Epub 2014 Mar 5. No abstract available.
citation: Wojcik-Cichy K, Koslinska-Berkan E, Piekarska A. The influence of NAFLD on the risk of atherosclerosis and cardiovascular diseases. Clin Exp Hepatol. 2018 Mar;4(1):1-6. doi: 10.5114/ceh.2018.73155. Epub 2018 Jan 20.