Lifestyle Modification Programme for HIV-infected Individuals With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Resolution of NAFLD
Study Overview
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) is rising in prevalence, and will likely become the predominant cause of chronic liver disease in HIV-infected individuals.
Metabolic factors and obesity are important risk factors for NAFLD in HIV-infected individuals. There is currently no approved effective pharmacological treatment for fatty liver disease. Therefore, lifestyle modification directing at weight loss is currently the cornerstone of treatment for fatty liver disease in the general population. Hypocaloric diets can improve fatty liver in the general population, but the most effective specific dietary interventions are yet to be elucidated.
The study aims to 1. determine the efficacy of a lifestyle modification programme in inducing resolution of NAFLD in HIV-infected individuals 2. to determine the efficacy of a lifestyle modification programme in improving insulin resistance, pro-inflammatory markers, and liver fibrosis in HIV-infected individuals with fatty liver disease 3. to determine changes in intestinal microbiome secondary to the lifestyle modification programme, and the association with resolution of NAFLD in this group of patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age 18 years or above
- •positive HIV antibody, on anti-retroviral therapy
- •HIV viral load ≤50 copies/mL for ≥6 months
- •intrahepatic triglyceride content ≥5% on magnetic resonance spectroscopy
Exclusion Criteria
- •current AIDS-defining illness
- •active malignancy, or history of malignancy within the last 5 years
- •hepatitis B and/or hepatitis C co-infection, as determined by positive HBsAg and anti--HCV antibody
- •alcohol consumption >30g per week in men or 20g per week in women
- •alanine aminotransferase (ALT) above 10 times the upper limit of normal
- •liver decompensation (as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 109/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices).
Outcomes
Primary Outcomes
Resolution of NAFLD
Time Frame: 12 months
The primary endpoint is the proportion of patients with resolution of NAFLD as determined by proton-magnetic resonance spectroscopy at month 12.
Secondary Outcomes
- Change in liver fibrosis(12 months)
- Partial resolution of NAFLD(12 months)
- Changes in adiposity(12 months)
- Metabolic endpoints(12 months)
- Biomarkers of inflammation and monocyte activation(12 months)
Investigators
Grace Lui
Clinical Assistant Professor
Chinese University of Hong Kong