Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04440540

Alternation of Non-alcoholic Fatty Liver Disease (NAFLD) and Cardiovascular Risks After Liftestyle Modification: A Ultrasound Attenuation Imaging-Based Study

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:
Effectiveness of Lifestyle Modification Program in Reversal of Non-alcoholic Fatty Liver Disease (NAFLD) and Reduction of Cardiovascular Risks in Moderate Obesity: A Ultrasound Attenuation Imaging-Based Study

Clinical Trial Summary

The prevalence of obesity has significantly increased over the last few decades. The excessive fat accumulation in undesired areas in obese patients may lead to various complications, such as cardiovascular diseases and Non-alcoholic fatty liver disease (NAFLD) defined by intrahepatic triglycerides (IHTG) content higher than 5.5%. In Hong Kong, the incidence rate of NAFLD is as high as approximately 13.5%, while 60.5% of obese subjects suffer from NAFLD. NAFLD is found to be a well-established risk factor for chronic kidney disease, type 2 diabetes, and cardiovascular disease. Moreover, obesity is a strong independent risk factor for development of atherosclerosis. It also plays important role in pathogenesis of dyslipidaemia, insulin resistance, hypertension. Both NAFLD and cardiovascular risks can be reversed. Lifestyle modification program(LMP) including diet control and routine exercise has been widely recommended to patients with mild to moderate obesity. It is vital to have a non-invasive, non-ionizing, low cost, accessible or widely available and yet accurate assessment tool to diagnose NAFLD and some cardiovascular risk parameters and serially monitor changes to assess the efficacy of LMP. Ultrasound meets these requirements. To the best of our knowledge there has been no prior study similar to this one. In this study, we aim to assess and validate the diagnostic accuracy of a novel ultrasound attenuation imaging method for NAFLD, and to evaluate the effectiveness of LMP in reversal of NAFLD and reduction of cardiovascular risks in moderate obesity. A total of forty moderate obese patients with NAFLD will be recruited in this study, divided into lifestyle modification program group(n=20) and usual care group(n=20). All subjects will undergo dietary assessment based on 3-day diet record and power of food scale. Demographic data will be recorded, consisted of age, weight, height, waist circumference, BMI, and so on. Ultrasound attenuation imaging (ATI) will be performed to measure tissue attenuation coefficient so as to evaluate liver steatosis and liver fibrosis stage. Meanwhile, magnetic resonance imaging (MRI) will be carried out, which include cardiovascular risks measurement, liver proton density fat fraction (PDFF), volume quantification of abdominal white adipose tissue, liver inflammation and fibrosis assessment. Biochemistry tests will be conducted as supplementary for assessment of NAFLD and cardiovascular risks, comprising liver function test, lipid, fasting glucose, etc.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04440540
Study type Interventional
Source Chinese University of Hong Kong
Contact
Status Terminated
Phase N/A
Start date July 2, 2020
Completion date June 30, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05480696 - Soluble Fibre Supplementation in NAFLD Phase 1
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Completed NCT04671186 - Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan N/A
Recruiting NCT05979779 - Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis Phase 2
Recruiting NCT05462353 - Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH Phase 2
Completed NCT05006885 - ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD) Phase 1
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Recruiting NCT04365855 - The Olmsted NAFLD Epidemiology Study (TONES) N/A
Recruiting NCT05618626 - Prevention of NAFLD and CVD Through Lifestyle Intervention N/A
Completed NCT03256526 - 6-week Safety and PD Study in Adults With NAFLD Phase 2
Enrolling by invitation NCT06152991 - Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy Phase 3
Completed NCT03681457 - Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects Phase 1
Completed NCT06244550 - Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors N/A
Not yet recruiting NCT05120557 - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH N/A
Completed NCT03060694 - Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements
Completed NCT02526732 - Hepatic Inflammation and Physical Performance in Patients With NASH N/A
Recruiting NCT01988441 - The Influence of Autophagy on Fatty Liver
Recruiting NCT01680003 - Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease Phase 2
Completed NCT01712711 - Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease Phase 2
Recruiting NCT00941642 - Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease Phase 4