Assessment of Nonalcoholic Fatty Liver Disease in Diabetic and Prediabetic Patients Using Noninvasive Methods.

• Conditions: Non Alcoholic Fatty Liver
• Interventions: Device: fibroscan

• Registration Number: NCT04553796
• Lead Sponsor: Assiut University

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 .

Study Timeline

• Study First Submitted: 2020-09-12
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-17
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-19
• Last Update Posted: 2020-12-23
• Study Start: 2021-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non diabetic participants	fibroscan	HBA1C : less than 5.7% Fasting Plasma Glucose : less than 100 mg/dl Oral Glucose Tolerance Test : less than 140 mg/dl
prediabetic participants	fibroscan	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
diabetic participants	fibroscan	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

Primary Outcome Measures

Name	Time	Method
correlation between lab and radiological methods	2 days	results of fibroscan, lab investigations include Complete blood picture Fasting plasma glucose (FBG) and Glycated hemoglobin (HbA1C) Liver function tests including ( serum bilirubin , serum albumin , ALT , AST , ALP , prothrombin time and INR ) kidney function tests. Lipid profile including (serum cholesterol and triglycerides ). hepatitis marker (HBs Ag , Anti-HCV Ab). and NAFLD Fibrosis Score will be correlated