Non-Alcoholic Fatty Liver Disease
Conditions
Keywords
ambulatory monitoring
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.
Interventions
BEHAVIORALAmbulatory 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.
BEHAVIORALStandard of care
Subjects will have follow-up every 6 months by hepatologists for routine care
Sponsors
The University of Hong Kong
Gense Technologies Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with significant hepatic fat change | 6 months | Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant MRI-PDFF change in NAFLD patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of hepatic fat change | 12 months | Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant MRI-PDFF change in NAFLD patients |
| Percentage of weight change | 6 months | Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant weight change in NAFLD patients |
| Percentage of subjects with normalisation of alanine aminotransferase | 6 months | Efficacy of ambulatory liver fat monitoring versus SOC in achieving normalisation of alanine aminotransferase among NAFLD subjects |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLung-Yi Mak, MD
The University of Hong Kong
Outcome results
None listed