Ambulatory Liver Fat Monitoring in Patients With Non-alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Behavioral: Ambulatory monitoring of liver fat
* Behavioral: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 patients with implanted electronic devices patients with spinal diseases/ discomfort patients with metallic implants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ambulatory liver fat monitoring<br>A novel portable, home-based device called the Gense-EIT liver scan will be given to each participant to practice ambulatory liver fat monitoring | Behavioral: Ambulatory monitoring of liver fat<br>* 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.<br>|
| Placebo Comparator: Standard of care<br>Subjects will have follow-up every 6 months by hepatologists for routine care | Behavioral: Standard of care<br>* Subjects will have follow-up every 6 months by hepatologists for routine care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of hepatic fat change | Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant MRI-PDFF change in NAFLD patients | 12 months | 
| Percentage of hepatic fat change | Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant CAP change in NAFLD patients | 6 months | 
| Percentage of weight change | Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant weight change in NAFLD patients | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ambulatory monitoring