Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver
NCT ID: NCT03913351
Last Updated: 2023-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
96 participants
INTERVENTIONAL
2019-05-21
2023-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lifestyle modification program
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.
Lifestyle 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.
Control
standard care of treatment, as in routine clinical practice
No interventions assigned to this group
Interventions
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Lifestyle 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Grace Lui
Clinical Assistant Professor
Locations
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Prince of Wales Hospital
Shatin, , Hong Kong
Countries
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Central Contacts
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References
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Li G, Wong VW, Chan RS, Sin DM, Chu W, Wong V, Cheung C, Lam S, Lin H, Yeung S, Li TC, Ho TH, Wong GL, Yip TC, Lui GC. Lifestyle modification programme for people living with HIV with metabolic dysfunction-associated steatotic liver disease: a randomised controlled trial. Lancet HIV. 2025 Jun;12(6):e416-e427. doi: 10.1016/S2352-3018(25)00032-3. Epub 2025 May 8.
Other Identifiers
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Study Protocol LSM V2
Identifier Type: -
Identifier Source: org_study_id
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