NAFLDNCT03913351
Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver
A study testing Lifestyle modification in people with NAFLD and Hiv, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteHong Kong
- Study dates
- 21 May 2019to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lifestyle Modification Programme for HIV-infected Individuals With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Trial
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.
- Being tested
- Lifestyle modification
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modificationBehavioural
The program consists of education on glycemic index, balanced diet, interpretation of food labels, food exchanges, healthy eating out techniques and healthy cooking methods.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle modification program | Experimental | 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. Receives: Behavioral: Lifestyle modification |
| Control | No intervention | standard care of treatment, as in routine clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of NAFLD
The primary endpoint is the proportion of patients with resolution of NAFLD as determined by proton-magnetic resonance spectroscopy at month 12.
Measured: 12 months
Secondary outcomes (12)
Partial resolution of NAFLD
Partial resolution of NAFLD is defined as absolute reduction of hepatic triglyceride content by 30% or more.
Measured: 12 months
Changes in adiposity
The changes in visceral fat will be determined by magnetic resonance imaging at the same session
Measured: 12 months
Change in liver fibrosis
The changes in liver fibrosis will be determined by transient elastography by Fibroscan
Measured: 12 months
Metabolic endpoints
The proportion of patients with impaired fasting glucose will be determined
Measured: 12 months
Metabolic endpoints
The proportion of patients with diabetes will be determined
Measured: 12 months
Metabolic endpoints
The proportion of patients with insulin resistance (estimated by the homeostasis model) will be determined
Measured: 12 months
Metabolic endpoints
The proportion of patients with hypertension will be determined
Measured: 12 months
Metabolic endpoints
The proportion of patients with dyslipidemia will be determined
Measured: 12 months
Metabolic endpoints
The proportion of patients with metabolic syndrome will be determined
Measured: 12 months
Biomarkers of inflammation and monocyte activation
Changes from baseline in adipokines (adiponectin and leptin)
Measured: 12 months
Biomarkers of inflammation and monocyte activation
Changes from baseline in marker of endothelial cell activation (ICAM-1)
Measured: 12 months
Biomarkers of inflammation and monocyte activation
Changes from baseline in marker of monocyte activation (sCD163)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start21 May 2019
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Lui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913351
- Sponsor's protocol ID
- Study Protocol LSM V2
- Status last verified
- Aug 2023
- First submitted
- 9 Apr 2019
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40347962
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Modification Programme for HIV-infected Individuals With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03913351
- Acronym / sponsor ID
- Study Protocol LSM V2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification program | Experimental | Behavioral: Lifestyle modificationThe 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. |
| Control | No intervention | –standard care of treatment, as in routine clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle modificationThe program consists of education on glycemic index, balanced diet, interpretation of food labels, food exchanges, healthy eating out techniques and healthy cooking methods. | Behavioural | Lifestyle modification program |
Primary outcome
Resolution of NAFLD
Time frame: 12 months
The primary endpoint is the proportion of patients with resolution of NAFLD as determined by proton-magnetic resonance spectroscopy at month 12.
12 secondary outcomes
Partial resolution of NAFLD
Time frame: 12 months
Changes in adiposity
Time frame: 12 months
Change in liver fibrosis
Time frame: 12 months
Metabolic endpoints
Time frame: 12 months
Metabolic endpoints
Time frame: 12 months
Metabolic endpoints
Time frame: 12 months
Metabolic endpoints
Time frame: 12 months
Metabolic endpoints
Time frame: 12 months
Metabolic endpoints
Time frame: 12 months
Biomarkers of inflammation and monocyte activation
Time frame: 12 months
Biomarkers of inflammation and monocyte activation
Time frame: 12 months
Biomarkers of inflammation and monocyte activation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Derived from this study: PubMed 40347962Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle modification in people with NAFLD and Hiv, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vivian Wong (+85259621224, vivianwong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of NAFLD (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03913351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.