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| Name | Class |
|---|---|
| Gense Technologies Ltd. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambulatory liver fat monitoring | Active Comparator | A novel portable, home-based device called the Gense-EIT liver scan will be given to each participant to practice ambulatory liver fat monitoring |
|
| Standard of care | Placebo Comparator | Subjects will have follow-up every 6 months by hepatologists for routine care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory monitoring of liver fat | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of hepatic fat change | Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant MRI-PDFF change in NAFLD patients | 12 months |
| Percentage of hepatic fat change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lung-Yi Mak, MD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Hong Kong | Select A State Or Province | 0000 | China |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Behavioral | Subjects will have follow-up every 6 months by hepatologists for routine care |
|
Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant CAP change in NAFLD patients
| 6 months |
| Percentage of weight change | Efficacy of ambulatory liver fat monitoring versus SOC in achieving significant weight change in NAFLD patients | 6 months |
| 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 |