Assessment of Nonalcoholic Fatty Liver Disease in Diabetic and Prediabetic Patients Using Noninvasive Methods.
NCT ID: NCT04553796
Last Updated: 2020-12-23
Study Results
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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UNKNOWN
150 participants
OBSERVATIONAL
2021-01-01
2022-03-01
Brief Summary
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Detailed Description
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NAFLD can range from simple steatosis in the absence of inflammation to nonalcoholic steatohepatitis, liver cirrhosis, and hepatocellular carcinoma (HCC) .
Major risk factors for NAFLD include obesity, hypertension , hyperlipidemia , hypertriglyceridemia , and type-2-diabetes mellitus (T2DM) .
The gold standard in the diagnosis of NAFLD is liver biopsy; however, it is sometimes associated with some complications that include bleeding, bile leak, infection, and other potential life-threatening issues. The accuracy of the MRI, computed tomography, and ultrasound imaging in diagnosis of NAFLD is low; hence, Fibroscan was introduced .
This is a non-invasive, simple-to-perform imaging modality with high accuracy to assess liver stiffness and hepatic fat deposition. Non-invasive diagnosis is based on clinical and biochemical markers, scoring models, and algorithms of methods which have sufficient sensitivity, specificity, and reproducibility .
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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diabetic participants
HBA1C : 6.5% or higher Fasting Plasma Glucose : 126 mg/dl or higher Oral Glucose Tolerance Test : 200 mg/dl or higher Random Plasma Glucose Test : greater than or equal to 200 mg/dl
fibroscan
Fibroscan is a non-invasive test that helps assess the health of your liver. Specifically, it uses ultrasound technology to determine the degree of fibrosis or scarring that may be present in your liver from various liver diseases or conditions
prediabetic participants
HBA1C : 5.7% to 6.4% Fasting Plasma Glucose : 100 mg/dl to 125 mg/dl Oral Glucose Tolerance Test : 140 mg/dl to 199 mg/dl
fibroscan
Fibroscan is a non-invasive test that helps assess the health of your liver. Specifically, it uses ultrasound technology to determine the degree of fibrosis or scarring that may be present in your liver from various liver diseases or conditions
non diabetic participants
HBA1C : less than 5.7% Fasting Plasma Glucose : less than 100 mg/dl Oral Glucose Tolerance Test : less than 140 mg/dl
fibroscan
Fibroscan is a non-invasive test that helps assess the health of your liver. Specifically, it uses ultrasound technology to determine the degree of fibrosis or scarring that may be present in your liver from various liver diseases or conditions
Interventions
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fibroscan
Fibroscan is a non-invasive test that helps assess the health of your liver. Specifically, it uses ultrasound technology to determine the degree of fibrosis or scarring that may be present in your liver from various liver diseases or conditions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients with viral hepatitis (HBV - HCV).
* Subjects with risk of 2nd hepatic steatosis liver disease (excessive alcohol consumption and medications).
* history of liver disease such as (α-1 antitrypsin deficiency, autoimmune hepatitis, drug-induced liver injury, 1ry biliary cirrhosis, 1ry sclerosing cholangitis).
* Body Mass Index (BMI) \> 35 (to avoid the possibility of Fibroscan failure).
18 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Michael Melad Fekry Endrawes
principal investigator
Principal Investigators
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lobna a ahmed, professor
Role: STUDY_CHAIR
Assiut University
Central Contacts
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References
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European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol. 2016 Jun;64(6):1388-402. doi: 10.1016/j.jhep.2015.11.004. Epub 2016 Apr 7. No abstract available.
Lv S, Jiang S, Liu S, Dong Q, Xin Y, Xuan S. Noninvasive Quantitative Detection Methods of Liver Fat Content in Nonalcoholic Fatty Liver Disease. J Clin Transl Hepatol. 2018 Jun 28;6(2):217-221. doi: 10.14218/JCTH.2018.00021. Epub 2018 Jun 22.
Bazick J, Donithan M, Neuschwander-Tetri BA, Kleiner D, Brunt EM, Wilson L, Doo E, Lavine J, Tonascia J, Loomba R. Clinical Model for NASH and Advanced Fibrosis in Adult Patients With Diabetes and NAFLD: Guidelines for Referral in NAFLD. Diabetes Care. 2015 Jul;38(7):1347-55. doi: 10.2337/dc14-1239. Epub 2015 Apr 17.
Dharmalingam M, Yamasandhi PG. Nonalcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus. Indian J Endocrinol Metab. 2018 May-Jun;22(3):421-428. doi: 10.4103/ijem.IJEM_585_17.
Esterson YB, Grimaldi GM. Radiologic Imaging in Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis. Clin Liver Dis. 2018 Feb;22(1):93-108. doi: 10.1016/j.cld.2017.08.005. Epub 2017 Oct 10.
de Ledinghen V, Vergniol J, Foucher J, Merrouche W, le Bail B. Non-invasive diagnosis of liver steatosis using controlled attenuation parameter (CAP) and transient elastography. Liver Int. 2012 Jul;32(6):911-8. doi: 10.1111/j.1478-3231.2012.02820.x.
Castera L, Friedrich-Rust M, Loomba R. Noninvasive Assessment of Liver Disease in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2019 Apr;156(5):1264-1281.e4. doi: 10.1053/j.gastro.2018.12.036. Epub 2019 Jan 18.
Sheth H, Bagasrawala S, Shah M, Ansari R, Olithselvan A, Lakdawala M. The HAALT Non-invasive Scoring System for NAFLD in Obesity. Obes Surg. 2019 Aug;29(8):2562-2570. doi: 10.1007/s11695-019-03880-x.
Wang CC, Jhu JJ. On the Application of Clustering and Classification Techniques to Analyze Metabolic Syndrome Severity Distribution Area and Critical Factors. Int J Environ Res Public Health. 2019 May 6;16(9):1575. doi: 10.3390/ijerph16091575.
American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S13-S28. doi: 10.2337/dc19-S002.
Angulo P, Hui JM, Marchesini G, Bugianesi E, George J, Farrell GC, Enders F, Saksena S, Burt AD, Bida JP, Lindor K, Sanderson SO, Lenzi M, Adams LA, Kench J, Therneau TM, Day CP. The NAFLD fibrosis score: a noninvasive system that identifies liver fibrosis in patients with NAFLD. Hepatology. 2007 Apr;45(4):846-54. doi: 10.1002/hep.21496.
Other Identifiers
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non alcoholic fatty liver
Identifier Type: -
Identifier Source: org_study_id