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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Lung-Yi Mak, MD
lungyi@hku.hk
85222554477
Backup
Wai-Kay Seto, MD
wkseto@hku.hk
85222554477
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 260
Treatments
Active_comparator: 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
Placebo_comparator: Standard of care
Subjects will have follow-up every 6 months by hepatologists for routine care
Sponsors
Leads: The University of Hong Kong
Collaborators: Gense Technologies Ltd.

This content was sourced from clinicaltrials.gov