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

NCT ID: NCT05754385

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-10-31

Brief 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.

Detailed 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.

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ambulatory liver fat monitoring

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

Group Type: ACTIVE_COMPARATOR

Ambulatory monitoring of liver fat

Intervention Type: BEHAVIORAL

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.

Standard of care

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

Group Type: PLACEBO_COMPARATOR

Standard of care

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Standard of care

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gense Technologies Ltd.

UNKNOWN

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lung-Yi Mak, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

The University of Hong Kong

Hong Kong, Select A State Or Province, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lung-Yi Mak, MD

Role: CONTACT

lungyi@hku.hk

85222554477

Wai-Kay Seto, MD

Role: CONTACT

wkseto@hku.hk

85222554477

Facility Contacts

Lung-Yi Mak, MD

Role: primary

lungyi@hku.hk

852 22554704

Wai-Kay Seto, MD

Role: backup

wkseto@hku.hk

852 22556979

Other Identifiers

HKU_EIT_am_liver

Identifier Type: -

Identifier Source: org_study_id