NCT05754385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

February 19, 2023

Last Update Submit

April 28, 2026

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

ambulatory monitoring

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects with significant hepatic fat change

    Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant MRI-PDFF change in NAFLD patients

    6 months

Secondary Outcomes (4)

  • Percentage of hepatic fat change

    12 months

  • Percentage of hepatic fat change

    6 months

  • Percentage of weight change

    6 months

  • Percentage of subjects with normalisation of alanine aminotransferase

    6 months

Study Arms (2)

Ambulatory liver fat monitoring

ACTIVE COMPARATOR

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

Behavioral: Ambulatory monitoring of liver fat

Standard of care

PLACEBO COMPARATOR

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

Behavioral: Standard of care

Interventions

Ambulatory monitoring of liver fatBEHAVIORAL

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.

Ambulatory liver fat monitoring
Standard of careBEHAVIORAL

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

Standard of care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Select A State Or Province, 0000, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Lung-Yi Mak, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 3, 2023

Study Start

May 1, 2023

Primary Completion

September 30, 2024

Study Completion

October 31, 2025

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

CN(1)