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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754385
• Other study ID #: HKU_EIT_am_liver
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: Lung-Yi Mak, MD
• Phone: 85222554477
• Email: lungyi[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: October 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Behavioral:
• 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.
• Standard of care
Subjects will have follow-up every 6 months by hepatologists for routine care

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong	Select A State Or Province

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Gense Technologies Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of hepatic fat change	Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant MRI-PDFF change in NAFLD patients	12 months
Secondary	Percentage of hepatic fat change	Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant CAP change in NAFLD patients	6 months
Secondary	Percentage of weight change	Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant weight change in NAFLD patients	6 months
Secondary	Percentage of subjects with normalisation of alanine aminotransferase	Efficacy of ambulatory liver fat monitoring versus SOC in achieving normalisation of alanine aminotransferase among NAFLD subjects	6 months