RECRUITINGINTERVENTIONAL

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

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

BEHAVIORAL

Ambulatory monitoring of liver fat

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.

BEHAVIORAL

Standard of care

Subjects will have follow-up every 6 months by hepatologists for routine care

Locations (1)

The University of Hong Kong

Hong Kong, Select A State Or Province, China