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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis B; Obese; Metabolic Associated Fatty Liver Disease; Lean; Pancreatic Steatosis
• Intervention / Treatment: Device: Abdominal Ultrasound; Device: Transient elastography; Diagnostic test: Waist Circumference; Diagnostic test: Body mass index

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 Type: Observational
• Enrollment (Actual): 217

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study was carried out in the Tropical Medicine and Infectious Diseases Department, Tanta University.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I; Obese chronic hepatitis B patients.	Device: Abdominal Ultrasound; Standard abdominal ultrasonography performed to evaluate pancreatic steatosis by comparing pancreatic echogenicity to liver and kidney tissue.; Device: Transient elastography; Non-invasive transient elastography used to assess hepatic steatosis and liver stiffness in patients with chronic hepatitis B.; Diagnostic test: Waist Circumference; The 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 test: Body mass index; It was calculated by the equation dividing the weight in kilograms by height in meters squared. BMI=〖mass〗_kg/(〖height〗_m^2 )
Group II; Lean chronic hepatitis B patients.	Device: Abdominal Ultrasound; Standard abdominal ultrasonography performed to evaluate pancreatic steatosis by comparing pancreatic echogenicity to liver and kidney tissue.; Device: Transient elastography; Non-invasive transient elastography used to assess hepatic steatosis and liver stiffness in patients with chronic hepatitis B.; Diagnostic test: Waist Circumference; The 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 test: Body mass index; It was calculated by the equation dividing the weight in kilograms by height in meters squared. BMI=〖mass〗_kg/(〖height〗_m^2 )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of hepatic steatosis	Frequency of hepatic steatosis (HS) were determined via transient elastography.	Immediately post-procedure (Up to 1 hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of pancreatic steatosis	Presence of pancreatic steatosis was evaluated via ultrasonography.	Immediately post-procedure (Up to 1 hour)

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2022
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: September 9, 2025
• First Submitted That Met QC Criteria: September 9, 2025
• First Posted (Estimated): September 16, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Nutrition Disorders; Chronic Disease; Disease Attributes; Overnutrition; Body Weight; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Overweight; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Hepatitis B; Obesity; Hepatitis B, Chronic; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Public Health; Environment and Public Health; Physiological Phenomena; Epidemiologic Measurements; Physical Examination; Body Size; Body Weights and Measures; Body Constitution; Anthropometry; Biometry; Waist Circumference; Body Mass Index
• Other Study ID Numbers: 35454/4/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No