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

Assiut University

Status: Unknown

Conditions: Non Alcoholic Fatty Liver

Treatments: Device: fibroscan

Study type: Observational

Funder types: Other

Identifiers

NCT04553796

non alcoholic fatty liver

Details and patient eligibility

About

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

Full 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 .

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

150 participants in 3 patient groups

diabetic participants

Description:

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

Treatment:

Device: fibroscan

prediabetic participants

Description:

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

Treatment:

Device: fibroscan

non diabetic participants

Description:

HBA1C : less than 5.7% Fasting Plasma Glucose : less than 100 mg/dl Oral Glucose Tolerance Test : less than 140 mg/dl

Treatment:

Device: fibroscan