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

Completed

• Conditions: Metabolic Associated Fatty Liver Disease; Pancreatic Steatosis; Obese; Lean; Chronic Hepatitis B

• Registration Number: NCT07175688
• Lead Sponsor: Tanta University

Brief 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.

Study Timeline

• Study Start: 2022-04-10
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

• Age 18 years or older.
• Both sexes.
• Chronic hepatitis B patients.

Exclusion Criteria

• Hepatitis C virus (HCV) antibody positive.
• Hepatocellular carcinoma (HCC).
• Human immunodeficiency viruses (HIV).
• Pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of hepatic steatosis	Immediately post-procedure (Up to 1 hour)	Frequency of hepatic steatosis (HS) were determined via transient elastography.

Secondary Outcome Measures

Name	Time	Method
Presence of pancreatic steatosis	Immediately post-procedure (Up to 1 hour)	Presence of pancreatic steatosis was evaluated via ultrasonography.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt