Lifestyle, Dietary Patterns, and Cardiometabolic Risk in Metabolic Dysfunction-Associated Steatotic Liver Disease Among People Living With HIV

October 1, 2026 updated by: Mohamed Ahmed Mostafa Ahmed, Assiut University

Evaluation of Lifestyle, Dietary Patterns, and Cardiometabolic Risk in Metabolic Dysfunction-Associated Steatotic Liver Disease Among People Living With HIV

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

250

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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).

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Significant alcohol consumption (>20 g/day for men or >10 g/day for women).
  • Pregnancy.
  • Current or prior history of malignancy.
  • Advanced liver cirrhosis.
  • Refusal to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: CASE_CONTROL
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort
People Living with HIV (PLWH)

Adult patients (≥18 years) with confirmed HIV infection, including both antiretroviral therapy (ART)-naïve and ART-experienced individuals. Participants undergo screening and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) and liver fibrosis using abdominal ultrasound, transient elastography (FibroScan), FIB-4 score, and NFS. Assessments include CD4+ T-cell count, CD4/CD8 ratio, routine laboratory tests, dietary quality and patterns (FFQ, short HEI), lifestyle adherence (Healthy Lifestyle Questionnaire), cardiometabolic risk profiling (PREVENT score, lipid profile, HbA1c), and mid-arm muscle circumference (MAMC).
Non-HIV Matched Controls

Adult individuals (≥18 years) confirmed to be HIV-negative, matched to cases by age, sex, and degree of MASLD. Participants undergo the same clinical, biochemical, hepatic (abdominal ultrasound, FibroScan, non-invasive fibrosis scores), dietary, lifestyle, and cardiometabolic risk assessments to serve as a comparative control cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Time Frame: Baseline

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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 1, 2026

First Submitted That Met QC Criteria

October 1, 2026

First Posted (Actual)

October 6, 2026

Study Record Updates

Last Update Posted (Actual)

October 6, 2026

Last Update Submitted That Met QC Criteria

October 1, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lifestyle and MASLD in HIV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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