Non-Alcoholic Fatty Liver DiseaseNCT05754385
Ambulatory Liver Fat Monitoring in Patients With Non-alcoholic Fatty Liver Disease
A study testing Ambulatory monitoring of liver fat in people with Non-Alcoholic Fatty Liver Disease, run by The University of Hong Kong at 1 site in China.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) affects 25% of the global population and causes serious complications, including cirrhosis, hepatocellular carcinoma or mortality. Unfortunately, there are not yet any approved drugs to treatment NAFLD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Ambulatory monitoring of liver fat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Oct 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with known NAFLD (diagnosed by ultrasonography or other forms of imaging; transient elastography with controlled attenuation parameter >248 dB/m; or liver biopsy) who are managed in the Liver Clinics of Queen Mary Hospital or Tung Wah Hospital
- aged 18-65 years
- without major cognitive impairment - since these subjects would be given simple instructions on using the ambulatory device to measure liver fat at home by themselves
Who cannot join
- on SGLT-2 inhibitors, GLP-1 agonists, or thiazolidinediones due to their prominent effects on body weight changes
- patients with cirrhosis (defined by imaging features of nodular liver and evidence of portal hypertension, liver stiffness >13 kPa, endoscopically proven gastroesophageal varices, or histological features), with or without ascites
- patients who are pregnant
- patients on special diet or with special dietary requirement (e.g., vegan, gluten free) heavy alcohol use (≥20 grams/ day for women or ≥30 grams/ day for men)
- history of HCC, hepatic resection, or LT
- patients with damaged skin on the abdomen, as this will affect the assessment by the ambulatory liver fat device
Show all 9Show fewer
- patients with implanted electronic devices
- patients with spinal diseases/ discomfort
- patients with metallic implants
Trial locations and contacts
1 site in 1 country.
China1 site
The University of Hong Kong
Hong Kong, Select A State Or Province, 0000
About this study
Official title: Effectiveness of Ambulatory Liver Fat Monitoring in Improvement of Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease: a Multi-center Randomized Controlled Trial
Non-alcoholic fatty liver disease (NAFLD) affects 25% of the global population and causes serious complications, including cirrhosis, hepatocellular carcinoma or mortality. Unfortunately, there are not yet any approved drugs to treatment NAFLD. The only effective means to improve NAFLD is by weight reduction via lifestyle modifications, i.e., diet and physical activity. Most NAFLD patients lack the motivation to initiate and maintain lifestyle modifications. The investigators hypothesize that ambulatory monitoring of liver fat can help NAFLD patients lose more liver fat by motivating them to gain a sense of control over their condition.
Read the detailed description
As NAFLD is a chronic medical illness, NAFLD patients are not able to receive timely feedback from their effort, and they are often frustrated. Also, living with NAFLD may not cause major perturbations to their usual life, as NAFLD is mostly asymptomatic and patients can easily forget the significance of this condition in the long run. The investigators plan to design a randomized, controlled, non-blinded, multi-centre study to compare the effects of ambulatory liver fat monitoring and standard of care in reduction of liver fat in NAFLD patients. Fibroscan and MRI-PDFF will be used for quantification of hepatic steatosis. Apart from the effect on liver fat, the investigators will also investigate whether ambulatory liver fat monitoring promotes more weight loss and improvement in liver biochemistry.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Ambulatory monitoring of liver fat, Standard of care
- Keywords
- ambulatory monitoring
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory monitoring of liver fatBehavioural
Participants will be given a novel portable, home-based device called the Gense-EIT liver scan the participants and will practice ambulatory liver fat monitoring for 6 months.
Standard of careBehavioural
Subjects will have follow-up every 6 months by hepatologists for routine care
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory liver fat monitoring | Active comparator | A novel portable, home-based device called the Gense-EIT liver scan will be given to each participant to practice ambulatory liver fat monitoring Receives: Behavioral: Ambulatory monitoring of liver fat |
| Standard of care | Placebo comparator | Subjects will have follow-up every 6 months by hepatologists for routine care Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with significant hepatic fat change
Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant MRI-PDFF change in NAFLD patients
Measured: 6 months
Secondary outcomes (4)
Percentage of hepatic fat change
Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant MRI-PDFF change in NAFLD patients
Measured: 12 months
Percentage of hepatic fat change
Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant CAP change in NAFLD patients
Measured: 6 months
Percentage of weight change
Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant weight change in NAFLD patients
Measured: 6 months
Percentage of subjects with normalisation of alanine aminotransferase
Efficacy of ambulatory liver fat monitoring versus SOC in achieving normalisation of alanine aminotransferase among NAFLD subjects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 May 2023
- Primary completion30 Sep 2024
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Gense Technologies Ltd.
- Responsible party
- Sponsor
- Investigators
- Lung-Yi Mak, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754385
- Sponsor's protocol ID
- HKU_EIT_am_liver
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ambulatory Liver Fat Monitoring in Improvement of Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease: a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05754385
- Acronym / sponsor ID
- HKU_EIT_am_liver
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- ambulatory monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Gense Technologies Ltd.
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 3 Mar 2023 (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) affects 25% of the global population and causes serious complications, including cirrhosis, hepatocellular carcinoma or mortality. Unfortunately, there are not yet any approved drugs to treatment NAFLD. The only effective means to improve NAFLD is by weight reduction via lifestyle modifications, i.e., diet and physical activity. Most NAFLD patients lack the motivation to initiate and maintain lifestyle modifications. The investigators hypothesize that ambulatory monitoring of liver fat can help NAFLD patients lose more liver fat by motivating them to gain a sense of control over their condition.
Detailed description
As NAFLD is a chronic medical illness, NAFLD patients are not able to receive timely feedback from their effort, and they are often frustrated. Also, living with NAFLD may not cause major perturbations to their usual life, as NAFLD is mostly asymptomatic and patients can easily forget the significance of this condition in the long run. The investigators plan to design a randomized, controlled, non-blinded, multi-centre study to compare the effects of ambulatory liver fat monitoring and standard of care in reduction of liver fat in NAFLD patients. Fibroscan and MRI-PDFF will be used for quantification of hepatic steatosis. Apart from the effect on liver fat, the investigators will also investigate whether ambulatory liver fat monitoring promotes more weight loss and improvement in liver biochemistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulatory liver fat monitoring | Active comparator | Behavioral: Ambulatory monitoring of liver fatA novel portable, home-based device called the Gense-EIT liver scan will be given to each participant to practice ambulatory liver fat monitoring |
| Standard of care | Placebo comparator | Behavioral: Standard of careSubjects will have follow-up every 6 months by hepatologists for routine care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with known NAFLD (diagnosed by ultrasonography or other forms of imaging; transient elastography with controlled attenuation parameter >248 dB/m; or liver biopsy) who are managed in the Liver Clinics of Queen Mary Hospital or Tung Wah Hospital
- aged 18-65 years
- without major cognitive impairment - since these subjects would be given simple instructions on using the ambulatory device to measure liver fat at home by themselves
Key exclusion criteria (9 listed)
- on SGLT-2 inhibitors, GLP-1 agonists, or thiazolidinediones due to their prominent effects on body weight changes
- patients with cirrhosis (defined by imaging features of nodular liver and evidence of portal hypertension, liver stiffness >13 kPa, endoscopically proven gastroesophageal varices, or histological features), with or without ascites
- patients who are pregnant
- patients on special diet or with special dietary requirement (e.g., vegan, gluten free) heavy alcohol use (≥20 grams/ day for women or ≥30 grams/ day for men)
- history of HCC, hepatic resection, or LT
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 |
|---|---|---|
| Ambulatory monitoring of liver fatParticipants will be given a novel portable, home-based device called the Gense-EIT liver scan the participants and will practice ambulatory liver fat monitoring for 6 months. | Behavioural | Ambulatory liver fat monitoring |
| Standard of careSubjects will have follow-up every 6 months by hepatologists for routine care | Behavioural | Standard of care |
Primary outcome
Percentage of subjects with significant hepatic fat change
Time frame: 6 months
Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant MRI-PDFF change in NAFLD patients
4 secondary outcomes
Percentage of hepatic fat change
Time frame: 12 months
Percentage of hepatic fat change
Time frame: 6 months
Percentage of weight change
Time frame: 6 months
Percentage of subjects with normalisation of alanine aminotransferase
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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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.
Lung-Yi Mak, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory monitoring of liver fat in people with Non-Alcoholic Fatty Liver Disease, run by The University of Hong Kong at 1 site in China.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 29 Apr 2026. 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 China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with significant hepatic fat change (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.