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CompletedNCT07175688

Metabolic Associated Fatty Liver Disease and Pancreatic Steatosis in Obese Versus Lean Chronic Hepatitis B Patients

Study of Metabolic Associated Fatty Liver Disease (MAFLD) and Pancreatic Steatosis in Obese Versus Lean Chronic Hepatitis B Patients

Status
Completed
Phase
Study type
Observational
Enrollment
217 (actual)
Sponsor
Tanta University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study aimed to evaluate the prevalence of metabolic associated fatty liver disease (MAFLD), fatty pancreas and hepatic fibrosis in obese and lean patients with chronic hepatitis B; either treatment naive or on treatment with first-line nucleos(t)ide analogs.

Detailed description

Hepatitis B virus (HBV) infection is one of the major etiologies of chronic liver disease. Pathologies caused by HBV infection range from chronic hepatitis, fibrosis, cirrhosis, to hepatocellular carcinoma (HCC). Obesity is another significant health burden. Abdominal obesity is a type of obesity that is commonly associated with severe metabolic disorders and cardiovascular diseases. Previous research has linked abdominal obesity to non-alcoholic fatty liver disease (NAFLD), insulin resistance, type 2 diabetes mellitus (T2DM), and even metabolic syndrome. In 2020, NAFLD was renamed metabolic-associated fatty liver disease (MAFLD) by a group of experts. MAFLD is defined by the presence of liver steatosis in addition to overweight/obesity, type 2 diabetes mellitus (T2DM), or metabolic dysregulation with at least two risk factors, such as an increased waist circumference, pre-diabetes, hypertension, hypertriglyceridemia, and low serum high-density lipoprotein (HDL)-cholesterol levels.

Conditions

Interventions

TypeNameDescription
DEVICEAbdominal UltrasoundStandard abdominal ultrasonography performed to evaluate pancreatic steatosis by comparing pancreatic echogenicity to liver and kidney tissue.
DEVICETransient elastographyNon-invasive transient elastography used to assess hepatic steatosis and liver stiffness in patients with chronic hepatitis B.
DIAGNOSTIC_TESTWaist CircumferenceThe midpoint between the superior aspect of the iliac crests and the lower lateral margins of the ribs using an inelastic tape (TBW Import Ltd) that was 0.5 cm in width and 200 cm in length, according to World Health Organization (WHO) recommendations. Abdominal obesity, determined as a waist circumference of ≥94 cm in males or ≥80 cm in females according to the recommendations of the International Diabetes Federation group
DIAGNOSTIC_TESTBody mass indexIt was calculated by the equation dividing the weight in kilograms by height in meters squared. BMI=〖mass〗\_kg/(〖height〗\_m\^2 )

Timeline

Start date
2022-04-10
Primary completion
2024-01-01
Completion
2024-01-01
First posted
2025-09-16
Last updated
2025-09-16

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07175688. Inclusion in this directory is not an endorsement.