Metabolic dysfunction-associated steatotic liver disease (MASLD), previously known as non-alcoholic fatty liver disease, is an increasingly recognized comorbidity in people living with human immunodeficiency virus (HIV). Chronic low-grade inflammation, altered lipid metabolism, and certain antiretroviral therapy (ART) regimens may heighten the vulnerability of people living with HIV (PLWH) to liver fat accumulation, progressive liver fibrosis, and cardiometabolic complications.
The primary purpose of this observational case-control study is to determine the prevalence, clinical characteristics, and laboratory findings of MASLD and hepatic fibrosis among PLWH compared with matched HIV-negative individuals. The study also aims to evaluate dietary quality, lifestyle habits, and cardiovascular risk profiles in both groups, and to determine whether adherence to a healthy lifestyle protects against significant liver disease.
Adult participants (aged 18 years and older) attending the Department of Tropical Medicine and Gastroenterology at Assiut University Hospitals will be enrolled into two groups: people living with HIV and HIV-negative individuals matched by age, sex, and degree of liver steatosis.
All participants will complete the following non-invasive evaluations:
* Hepatic Assessment: Abdominal ultrasound and transient elastography (FibroScan) to detect fatty liver and quantify liver stiffness, alongside non-invasive scoring systems (FIB-4 score and NAFLD Fibrosis Score). * Laboratory Investigations: Fasting blood tests including liver function tests, lipid profiles, glycemic status (HbA1c), kidney function, complete blood count, and immune markers (CD4+ T-cell count and CD4/CD8 ratio). * Physical and Body Measurements: Measurement of body mass index (BMI), waist circumference, and mid-arm muscle circumference (MAMC). * Dietary and Lifestyle Questionnaires: Validated assessment tools including the Food Frequency Questionnaire (FFQ), Short Healthy Eating Index (sHEI), and Healthy Lifestyle Questionnaire to quantify nutritional quality, physical activity, and daily lifestyle habits. * Cardiometabolic Risk Calculation: Calculation of predicted cardiovascular risk using the American Heart Association PREVENT risk score.
Findings from this study are intended to clarify the role of dietary quality and lifestyle factors in liver and metabolic health among people living with HIV, potentially informing proactive screening and management strategies.
Age 18 years or older.
Confirmed HIV infection (for the case cohort), including both antiretroviral therapy (ART)-naïve and ART-experienced individuals.
Confirmed HIV-negative status (for the control cohort), matched by age, sex, and degree of metabolic dysfunction-associated steatotic liver disease (MASLD).
Ability and willingness to provide written informed consent.
Significant alcohol consumption (>20 g/day for men or >10 g/day for women).
Pregnancy.
Current or prior history of malignancy.
Advanced liver cirrhosis.
The study population comprises adult patients living with HIV (both antiretroviral therapy-naïve and treatment-experienced) and HIV-negative individuals attending the Department of Tropical Medicine and Gastroenterology and the Endoscopy Unit at the Faculty of Medicine, Assiut University Hospitals, Egypt. Control subjects are recruited from the same clinical setting and matched to HIV cases according to age, sex, and degree of metabolic dysfunction-associated steatotic liver disease (MASLD).
Case-control
Cross-sectional
Not listed
Percentage of Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Hepatic steatosis is assessed by abdominal ultrasound and transient elastography (Controlled Attenuation Parameter \[CAP\]). MASLD is diagnosed based on the presence of hepatic steatosis in conjunction with at least one cardiometabolic risk factor (such as elevated BMI, waist circumference, dyslipidemia, hypertension, or impaired fasting glucose/HbA1c) and the exclusion of secondary causes of hepatic steatosis (including significant alcohol consumption). The outcome will be reported as the proportion (percentage) of participants meeting diagnostic criteria for MASLD in each study cohort.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
