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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07175688
Enrollment
217
Registered
2025-09-16
Start date
2022-04-10
Completion date
2024-01-01
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

DEVICEAbdominal Ultrasound

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

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 )

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of hepatic steatosisImmediately post-procedure (Up to 1 hour)Frequency of hepatic steatosis (HS) were determined via transient elastography.

Secondary

MeasureTime frameDescription
Presence of pancreatic steatosisImmediately post-procedure (Up to 1 hour)Presence of pancreatic steatosis was evaluated via ultrasonography.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026