Hiv, NAFLD
Conditions
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.
Interventions
BEHAVIORALLifestyle modification
The program consists of education on glycemic index, balanced diet, interpretation of food labels, food exchanges, healthy eating out techniques and healthy cooking methods.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of NAFLD | 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
| Measure | Time frame | Description |
|---|---|---|
| Partial resolution of NAFLD | 12 months | Partial resolution of NAFLD is defined as absolute reduction of hepatic triglyceride content by 30% or more. |
| Changes in adiposity | 12 months | The changes in visceral fat will be determined by magnetic resonance imaging at the same session |
| Change in liver fibrosis | 12 months | The changes in liver fibrosis will be determined by transient elastography by Fibroscan |
| Metabolic endpoints | 12 months | The proportion of patients with impaired fasting glucose will be determined |
| Biomarkers of inflammation and monocyte activation | 12 months | Changes from baseline in adipokines (adiponectin and leptin) |
Countries
Hong Kong
Contacts
Primary ContactVivian Wong
Backup ContactGrace Lui
Outcome results
None listed