Monitoring liver fat 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

This study is testing whether a device that lets people with non-alcoholic fatty liver disease monitor their liver fat at home can help them make healthier lifestyle changes and improve their liver health compared to standard care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The University of Hong Kong (other)
• Locations: 1 site (Hong Kong, Select A State Or Province)
• Trial ID: NCT05754385 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of ambulatory liver fat monitoring in patients diagnosed with non-alcoholic fatty liver disease (NAFLD). By providing patients with a device to monitor their liver fat levels at home, the researchers hope to motivate lifestyle changes that can lead to weight loss and improved liver health. The study will compare the outcomes of patients using this monitoring approach against those receiving standard care. Measurements will be taken using Fibroscan and MRI-PDFF to quantify liver fat reduction and assess changes in liver biochemistry.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a confirmed diagnosis of NAFLD and no major cognitive impairments.

Not a fit: Patients with cirrhosis, those on specific medications affecting weight, or individuals with special dietary requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could empower patients to better manage their NAFLD and achieve significant health improvements.

How similar studies have performed: While the concept of ambulatory monitoring is gaining traction, this specific approach to NAFLD management is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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

Where this trial is running

Hong Kong, Select A State Or Province

• The University of Hong Kong — Hong Kong, Select A State Or Province, China (RECRUITING)

Study contacts

• Principal investigator: Lung-Yi Mak, MD — The University of Hong Kong
• Study coordinator: Lung-Yi Mak, MD

Conditions: Non-Alcoholic Fatty Liver Disease, ambulatory monitoring