Back to resultsAmbulatory Liver Fat Monitoring in Patients With Non-alcoholic Fatty Liver Disease
Primary Purpose
Non-Alcoholic Fatty Liver Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ambulatory monitoring of liver fat
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring ambulatory monitoring
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
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ambulatory liver fat monitoring
Standard of care
Arm 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
Subjects will have follow-up every 6 months by hepatologists for routine care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Percentage of hepatic fat change
Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant MRI-PDFF change in NAFLD patients
Percentage of hepatic fat change
Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant CAP change in NAFLD patients
Percentage of weight change
Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant weight change in NAFLD patients
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
Full Information
NCT ID
NCT05754385
First Posted
February 19, 2023
Last Updated
March 1, 2023
Sponsor
The University of Hong Kong
Collaborators
Gense Technologies Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05754385
Brief Title
Ambulatory Liver Fat Monitoring in Patients With Non-alcoholic Fatty Liver Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
Collaborators
Gense Technologies Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
Keywords
ambulatory monitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ambulatory liver fat monitoring
Arm Type
Active Comparator
Arm 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
Arm Title
Standard of care
Arm Type
Placebo Comparator
Arm Description
Subjects will have follow-up every 6 months by hepatologists for routine care
Intervention Type
Behavioral
Intervention Name(s)
Ambulatory monitoring of liver fat
Intervention Description
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
Intervention Name(s)
Standard of care
Intervention Description
Subjects will have follow-up every 6 months by hepatologists for routine care
Primary Outcome Measure Information:
Title
Percentage of subjects with significant hepatic fat change
Description
Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant MRI-PDFF change in NAFLD patients
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of hepatic fat change
Description
Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant MRI-PDFF change in NAFLD patients
Time Frame
12 months
Title
Percentage of hepatic fat change
Description
Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant CAP change in NAFLD patients
Time Frame
6 months
Title
Percentage of weight change
Description
Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant weight change in NAFLD patients
Time Frame
6 months
Title
Percentage of subjects with normalisation of alanine aminotransferase
Description
Efficacy of ambulatory liver fat monitoring versus SOC in achieving normalisation of alanine aminotransferase among NAFLD subjects
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lung-Yi Mak, MD
Phone
85222554477
Email
lungyi@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Wai-Kay Seto, MD
Phone
85222554477
Email
wkseto@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lung-Yi Mak, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
State/Province
Select A State Or Province
ZIP/Postal Code
0000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Ambulatory Liver Fat Monitoring in Patients With Non-alcoholic Fatty Liver Disease
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