Clinical trial NCT05754385: 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
Overall status: RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: ambulatory monitoring
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Gense Technologies Ltd.
First posted: 2023-03-03
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of subjects with significant hepatic fat change
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of hepatic fat change
timeFrame: 12 months
measure: Percentage of hepatic fat change
timeFrame: 6 months
measure: Percentage of weight change
timeFrame: 6 months
measure: Percentage of subjects with normalisation of alanine aminotransferase
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
state: Select A State Or Province
Study officials:
affiliation: The University of Hong Kong
name: Lung-Yi Mak, MD
role: PRINCIPAL_INVESTIGATOR
References: