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NCT03913351

Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver

Status unknown NA Last updated 30 August 2023
What this trial tests

NA trial testing Lifestyle modification in NAFLD in 96 participants. Status unknown.

Timeline
21 May 2019
Primary endpoint
30 December 2023
30 December 2023

Quick facts

Lead sponsorChinese University of Hong Kong
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment96
Start date21 May 2019
Primary completion30 December 2023
Estimated completion30 December 2023
Sites1 location across Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

Chinese University of Hong Kong

Who can join

18 and older, any sex, with NAFLD or Hiv. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Lifestyle modification programme for people living with HIV with metabolic dysfunction-associated steatotic liver disease: a randomised controlled trial.
    Li G, Wong VW, Chan RS, Sin DM, et al · · 2025 · cited 4× · PMID 40347962 · DOI 10.1016/s2352-3018(25)00032-3

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Other trials of Lifestyle modification

Trials testing the same drug.

Other recruiting trials for NAFLD

Currently open trials in the same condition.

Other Chinese University of Hong Kong trials

Trials by the same sponsor.

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