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Not Yet Recruiting NCT05754385

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

Conditions: Non-Alcoholic Fatty Liver Disease

Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 260
Sponsor: The University of Hong Kong

Location: China

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.

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 Hospitalaged 18-65 yearswithout major cognitive impairment - since these subjects would be given simple instructions on using the ambulatory device to measure liver fat at home by themselvesExclusion Criteria:on SGLT-2 inhibitors, GLP-1 agonists, or thiazolidinediones due to their prominent effects on body weight changespatients 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 ascitespatients who are pregnantpatients 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 LTpatients with damaged skin on the abdomen, as this will affect the assessment by the ambulatory liver fat devicepatients with implanted electronic devicespatients with spinal diseases/ discomfortpatients with metallic implants

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05754385). StuddyBuddy aggregates publicly available trial information.