Trials / Completed
CompletedNCT07175688
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 217 (actual)
- Sponsor
- Tanta University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Abdominal Ultrasound | Standard abdominal ultrasonography performed to evaluate pancreatic steatosis by comparing pancreatic echogenicity to liver and kidney tissue. |
| DEVICE | Transient elastography | Non-invasive transient elastography used to assess hepatic steatosis and liver stiffness in patients with chronic hepatitis B. |
| DIAGNOSTIC_TEST | 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 |
| 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 ) |
Timeline
- Start date
- 2022-04-10
- Primary completion
- 2024-01-01
- Completion
- 2024-01-01
- First posted
- 2025-09-16
- Last updated
- 2025-09-16
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT07175688. Inclusion in this directory is not an endorsement.