Relation Between Carotid Atheroscerosis With DM &Fatty Liver

NCT ID: NCT05532553

Last Updated: 2022-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-10-01

Brief Summary

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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

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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.

Conditions

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Atherosclerosis With Diabetes Mellitus and Fatty Liver

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

Patient with T2DM and fatty liver.

Carotid Doppler U/S

Intervention Type DEVICE

Measurement of carotid intima media thickness by carotid doppler ultrasound

Group 2

patients with fatty liver only ( control group).

Carotid Doppler U/S

Intervention Type DEVICE

Measurement of carotid intima media thickness by carotid doppler ultrasound

Interventions

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Carotid Doppler U/S

Measurement of carotid intima media thickness by carotid doppler ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Dina Ehab Makram

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walaa Anwar Mohamed Khalifa, Doctor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Dina Ehab Makram, Resident doctor

Role: CONTACT

01288852317

Enas Ahmed Reda El kareemy, Professor

Role: CONTACT

0 100 000 4303

References

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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.

Reference Type BACKGROUND
PMID: 26167390 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30414863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28652891 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25560844 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26856933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19766548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17081293 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29219149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24613323 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29594192 (View on PubMed)

Other Identifiers

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Atherosclerosis With DM&fatty

Identifier Type: -

Identifier Source: org_study_id

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