Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver
- Conditions
- HivNAFLD
- Interventions
- Behavioral: Lifestyle modification
- Registration Number
- NCT03913351
- Lead Sponsor
- Chinese University of Hong Kong
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lifestyle modification program Lifestyle modification The dietary intervention program will be scheduled for 12 months, and conducted by a dietitian.The program aims to increase energy expenditure and reduce caloric intake, with an emphasis on long-term lifestyle and behavioural change. An exercise instructor will provide advice on physical activity. A mobile tracking device to monitor calories expenditure will be provided to each participant during they study period to encourage physical activity.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in liver fibrosis 12 months The changes in liver fibrosis will be determined by transient elastography by Fibroscan
Biomarkers of inflammation and monocyte activation 12 months Changes from baseline in marker of monocyte activation (sCD163)
Metabolic endpoints 12 months The proportion of patients with metabolic syndrome will be determined
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
Trial Locations
- Locations (1)
Prince of Wales Hospital
🇭🇰Shatin, Hong Kong