Assessment of Nonalcoholic Fatty Liver Disease in Diabetic and Prediabetic Patients Using Noninvasive Methods.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Assiut University
- Enrollment
- 150
- Primary Endpoint
- correlation between lab and radiological methods
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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).
Outcomes
Primary Outcomes
correlation between lab and radiological methods
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Michael Melad Fekry Endrawes
principal investigator
Assiut University