Ambulatory Liver Fat Monitoring in Patients With Non-alcoholic Fatty Liver Disease
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
The University of Hong Kong
260 participants
May 1, 2023
INTERVENTIONAL
Conditions
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. 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.
Eligibility
Inclusion Criteria3
- 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 Criteria9
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Subjects will have follow-up every 6 months by hepatologists for routine care
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05754385