Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)NCT07861594
Lifestyle, Dietary Patterns, and Cardiometabolic Risk in Metabolic Dysfunction-Associated Steatotic Liver Disease Among People Living With HIV
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and HIV Infections, run by Assiut University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), HIV Infections, Non-Alcoholic Fatty Liver Disease
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read more
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.
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), HIV Infections, Non-Alcoholic Fatty Liver Disease, Liver Cirrhosis
- Keywords
- MASLD, People Living with HIV, Cardiometabolic Risk, Dietary Patterns, Healthy Lifestyle, FibroScan, Transient Elastography, PREVENT Risk Score, Antiretroviral Therapy, Hepatic Steatosis
- Medical subject headings
- HIV Infections, Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Studies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mostafa Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861594
- Sponsor's protocol ID
- Lifestyle and MASLD in HIV
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lifestyle, Dietary Patterns, and Cardiometabolic Risk in Metabolic Dysfunction-Associated Steatotic Liver Disease Among People Living With HIV
- ClinicalTrials.gov ID
- NCT07861594
- Acronym / sponsor ID
- Lifestyle and MASLD in HIV
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), HIV Infections, Non-Alcoholic Fatty Liver Disease, Liver Cirrhosis
- Keywords
- MASLD, People Living with HIV, Cardiometabolic Risk, Dietary Patterns, Healthy Lifestyle, FibroScan, Transient Elastography, PREVENT Risk Score
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Oct 2026 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and HIV Infections, run by Assiut University.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (time frame: Baseline). 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 6 Oct 2026.