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

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Behavioral: Standard of care; Behavioral: Ambulatory monitoring of liver fat

Study type: Interventional

Funder types: Other

Identifiers

NCT05754385

HKU_EIT_am_liver

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

260 participants in 2 patient groups, including a placebo group

Ambulatory liver fat monitoring

Active Comparator group

Description:

A novel portable, home-based device called the Gense-EIT liver scan will be given to each participant to practice ambulatory liver fat monitoring

Treatment:

Behavioral: Ambulatory monitoring of liver fat

Standard of care

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Standard of care