Metabolic Associated Fatty Liver DiseaseNCT07175688
Metabolic Associated Fatty Liver Disease and Pancreatic Steatosis in Obese Versus Lean Chronic Hepatitis B Patients
An observational study of Metabolic Associated Fatty Liver Disease and Pancreatic Steatosis, run by Tanta University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Associated Fatty Liver Disease, Pancreatic Steatosis, Obese
- What is being tested?
- Abdominal Ultrasound, Transient elastography and Waist Circumference
- Type of treatment
- Medical device
- How many people
- 217 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2022to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study was carried out in the Tropical Medicine and Infectious Diseases Department, Tanta University.
Who may be able to join
- Age 18 years or older.
- Both sexes.
- Chronic hepatitis B patients.
Who cannot join
- Hepatitis C virus (HCV) antibody positive.
- Hepatocellular carcinoma (HCC).
- Human immunodeficiency viruses (HIV).
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Metabolic Associated Fatty Liver Disease (MAFLD) 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.
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.
- Conditions
- Metabolic Associated Fatty Liver Disease, Pancreatic Steatosis, Obese, Lean, Chronic Hepatitis B
- Being tested
- Abdominal Ultrasound, Transient elastography, Waist Circumference, Body mass index
- Medical subject headings
- Obesity, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal UltrasoundDevice
Standard abdominal ultrasonography performed to evaluate pancreatic steatosis by comparing pancreatic echogenicity to liver and kidney tissue.
Transient elastographyDevice
Non-invasive transient elastography used to assess hepatic steatosis and liver stiffness in patients with chronic hepatitis B.
Waist CircumferenceDiagnostic 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 indexDiagnostic test
It was calculated by the equation dividing the weight in kilograms by height in meters squared.
BMI=〖mass〗_kg/(〖height〗_m^2 )
| Study group | Role | What they receive |
|---|---|---|
| Group I | Obese chronic hepatitis B patients. Receives: Device: Abdominal Ultrasound; Device: Transient elastography; Diagnostic Test: Waist Circumference; Diagnostic Test: Body mass index | |
| Group II | Lean chronic hepatitis B patients. Receives: Device: Abdominal Ultrasound; Device: Transient elastography; Diagnostic Test: Waist Circumference; Diagnostic Test: Body mass index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of hepatic steatosis
Frequency of hepatic steatosis (HS) were determined via transient elastography.
Measured: Immediately post-procedure (Up to 1 hour)
Secondary outcomes (1)
Presence of pancreatic steatosis
Presence of pancreatic steatosis was evaluated via ultrasonography.
Measured: Immediately post-procedure (Up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start10 Apr 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Associated Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Hosny Salama, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175688
- Sponsor's protocol ID
- 35454/4/22
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Metabolic Associated Fatty Liver Disease (MAFLD) and Pancreatic Steatosis in Obese Versus Lean Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT07175688
- Acronym / sponsor ID
- 35454/4/22
- Conditions
- Metabolic Associated Fatty Liver Disease, Pancreatic Steatosis, Obese, Lean, Chronic Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Device: Abdominal Ultrasound, Device: Transient elastography, Diagnostic Test: Waist Circumference, Diagnostic Test: Body mass indexObese chronic hepatitis B patients. |
| Group II | – | Device: Abdominal Ultrasound, Device: Transient elastography, Diagnostic Test: Waist Circumference, Diagnostic Test: Body mass indexLean chronic hepatitis B patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was carried out in the Tropical Medicine and Infectious Diseases Department, Tanta University.
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Both sexes.
- Chronic hepatitis B patients.
Key exclusion criteria (4 listed)
- Hepatitis C virus (HCV) antibody positive.
- Hepatocellular carcinoma (HCC).
- Human immunodeficiency viruses (HIV).
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal UltrasoundStandard abdominal ultrasonography performed to evaluate pancreatic steatosis by comparing pancreatic echogenicity to liver and kidney tissue. | Device | Group I, Group II |
| Transient elastographyNon-invasive transient elastography used to assess hepatic steatosis and liver stiffness in patients with chronic hepatitis B. | Device | Group I, Group II |
| Waist CircumferenceThe 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 | Group I, Group II |
| Body mass indexIt was calculated by the equation dividing the weight in kilograms by height in meters squared. BMI=〖mass〗_kg/(〖height〗_m^2 ) | Diagnostic test | Group I, Group II |
Primary outcome
Frequency of hepatic steatosis
Time frame: Immediately post-procedure (Up to 1 hour)
Frequency of hepatic steatosis (HS) were determined via transient elastography.
1 secondary outcome
Presence of pancreatic steatosis
Time frame: Immediately post-procedure (Up to 1 hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Associated Fatty Liver Disease and Pancreatic Steatosis, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of hepatic steatosis (time frame: Immediately post-procedure (Up to 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.