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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
The program consists of education on glycemic index, balanced diet, interpretation of food labels, food exchanges, healthy eating out techniques and healthy cooking methods.
Prince of Wales Hospital
Shatin, Hong Kong
RECRUITINGResolution of NAFLD
The primary endpoint is the proportion of patients with resolution of NAFLD as determined by proton-magnetic resonance spectroscopy at month 12.
Time frame: 12 months
Partial resolution of NAFLD
Partial resolution of NAFLD is defined as absolute reduction of hepatic triglyceride content by 30% or more.
Time frame: 12 months
Changes in adiposity
The changes in visceral fat will be determined by magnetic resonance imaging at the same session
Time frame: 12 months
Change in liver fibrosis
The changes in liver fibrosis will be determined by transient elastography by Fibroscan
Time frame: 12 months
Metabolic endpoints
The proportion of patients with impaired fasting glucose will be determined
Time frame: 12 months
Metabolic endpoints
The proportion of patients with diabetes will be determined
Time frame: 12 months
Metabolic endpoints
The proportion of patients with insulin resistance (estimated by the homeostasis model) will be determined
Time frame: 12 months
Metabolic endpoints
The proportion of patients with hypertension will be determined
Time frame: 12 months
Metabolic endpoints
The proportion of patients with dyslipidemia will be determined
Time frame: 12 months
Metabolic endpoints
The proportion of patients with metabolic syndrome will be determined
Time frame: 12 months
Biomarkers of inflammation and monocyte activation
Changes from baseline in adipokines (adiponectin and leptin)
Time frame: 12 months
Biomarkers of inflammation and monocyte activation
Changes from baseline in marker of endothelial cell activation (ICAM-1)
Time frame: 12 months
Biomarkers of inflammation and monocyte activation
Changes from baseline in marker of monocyte activation (sCD163)
Time frame: 12 months
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