Clinical trial NCT04553796: Assessment of Nonalcoholic Fatty Liver Disease in Diabetic and Prediabetic Patients Using Noninvasive Methods.
Official title: Assessment of Nonalcoholic Fatty Liver Disease in Diabetic and Prediabetic Patients Using Noninvasive Methods.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Alcoholic Fatty Liver
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: participants older than 18 years with no definite cause of nafld in our out patient clinic.

Brief summary: assessment of NAFLD among diabetic, pre-diabetic and non diabetic participants Using Non Invasive Methods.And correlation between lab and radiological methods .

Detailed description: Non alcoholic fatty liver disease (NAFLD) is a major public health problem. with 10-30% prevalence worldwide , and is a common cause of chronic liver disease and the third most common cause of liver transplantation .

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 .

Eligibility criteria: Inclusion Criteria:

* the participants are divided into 3 groups: the diabetic group patients (T2DM) ,the pre-diabetic and the non diabetic one. The diagnosis will be according to the American Diabetes Association (ADA) clinical practice recommendations-2019

Exclusion Criteria:

* patients under the age of 18.
* 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).

Primary outcomes:
measure: correlation between lab and radiological methods
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: lobna a ahmed, professor
role: STUDY_CHAIR
References:
citation: 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.
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citation: 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.
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citation: 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.
citation: 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.
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citation: 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.