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

NCT ID: NCT07175688

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

217 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-10

Study Completion Date

2024-01-01

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group I

Obese chronic hepatitis B patients.

Abdominal Ultrasound

Intervention Type DEVICE

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

Transient elastography

Intervention Type DEVICE

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

Waist Circumference

Intervention Type 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

Intervention Type 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 II

Lean chronic hepatitis B patients.

Abdominal Ultrasound

Intervention Type DEVICE

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

Transient elastography

Intervention Type DEVICE

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

Waist Circumference

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

It was calculated by the equation dividing the weight in kilograms by height in meters squared.

BMI=〖mass〗\_kg/(〖height〗\_m\^2 )

Interventions

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Abdominal Ultrasound

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

Intervention Type DEVICE

Transient elastography

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

Intervention Type DEVICE

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

Intervention Type 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 )

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Samar Hosny Salama

Assistant lecturer of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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35454/4/22

Identifier Type: -

Identifier Source: org_study_id

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