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Completed

NCT Number: NCT07175688

Metabolic Associated Fatty Liver Disease 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abdominal Ultrasound

Device

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

Transient elastography

Device

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

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

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 )

Primary outcomes

  1. Frequency of hepatic steatosis

    Time frame: Immediately post-procedure (Up to 1 hour)

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

Secondary outcomes

  1. Presence of pancreatic steatosis

    Time frame: Immediately post-procedure (Up to 1 hour)

    Presence of pancreatic steatosis was evaluated via ultrasonography.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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