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CompletedNCT07175688Updated Sep 16, 2025

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

An observational study in Metabolic Associated Fatty Liver Disease, Pancreatic Steatosis and Obese, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Tanta University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
217
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Metabolic Associated Fatty Liver Disease
  • Pancreatic Steatosis
  • Obese
  • Lean
  • Chronic Hepatitis B
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 217 is above the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Hepatitis C virus (HCV) antibody positive.
  • Hepatocellular carcinoma (HCC).
  • Human immunodeficiency viruses (HIV).
  • Pregnancy.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
217 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceAbdominal Ultrasound

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

  • DeviceTransient elastography

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

  • Diagnostic testWaist 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 testBody mass index

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

06

What researchers measure

Primary outcomes

  1. Frequency of hepatic steatosis

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

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

Secondary outcomes

  1. Presence of pancreatic steatosis

    Presence of pancreatic steatosis was evaluated via ultrasonography.

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

07

Study locations

1 site
  • Tanta University
    Tanta, El-Gharbia 31527, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07175688
Lead sponsor
Tanta University
Responsible party
Samar Hosny Salama (Assistant lecturer of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt., Tanta University) — Principal investigator
First posted
Sep 16, 2025
Start date
Apr 10, 2022
Primary completion
Jan 1, 2024
Completion
Jan 1, 2024
Last update
Sep 16, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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