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

NCT07175688 | Completed

• 1 other identifier: 35454/4/22
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Frequency of hepatic steatosis

  Frequency of hepatic steatosis (HS) were determined via transient elastography.

  Immediately post-procedure (Up to 1 hour)

Secondary Outcomes (1)

• Presence of pancreatic steatosis

  Immediately post-procedure (Up to 1 hour)

Study Arms (2)

Group I

Obese chronic hepatitis B patients.

Device: Abdominal Ultrasound; Device: Transient elastography; Diagnostic Test: Waist Circumference; Diagnostic Test: Body mass index

Group II

Lean chronic hepatitis B patients.

Device: Abdominal Ultrasound; Device: Transient elastography; Diagnostic Test: Waist Circumference; Diagnostic Test: Body mass index

Interventions

Abdominal Ultrasound DEVICE

Standard abdominal ultrasonography performed to evaluate pancreatic steatosis by comparing pancreatic echogenicity to liver and kidney tissue.

Group I; Group II

Transient elastography DEVICE

Non-invasive transient elastography used to assess hepatic steatosis and liver stiffness in patients with chronic hepatitis B.

Group I; Group II

Waist Circumference DIAGNOSTIC_TEST

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

Group I; Group II

Body mass index DIAGNOSTIC_TEST

It was calculated by the equation dividing the weight in kilograms by height in meters squared. BMI=〖mass〗\_kg/(〖height〗\_m\^2 )

Group I; Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Obesity; Hepatitis B, Chronic

Interventions

Waist Circumference; Body Mass Index

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: April 10, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)