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临床试验/NCT04440540
NCT04440540终止不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
1
主要终点
cardiovascular risks

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • With age range of 18-65 years.
  • With diagnosis of NAFLD.
  • BMI =27.5- 32.4kg/m2 for moderate obesity (Asian population)
  • Written consent form obtained.

排除标准

  • Other kind of hepatic diseases or under medications known to affect liver fat accumulation.
  • Excessive alcohol consumption (>20g/d for men and >10g/d for women).
  • Subjects using thyroid hormones, oestrogens, amiodarone, steroids, tamoxifen and beta blockers (e.g. propranolol).
  • Body weight >250kgs and or/ waist circumference > 150cm.

结局指标

主要结局

cardiovascular risks

时间窗: 1 year

cardiovascular risks reflected by Intima-media thicknesses of both carotid arteries

intrahepatic triglycerides (IHTG) content

时间窗: 1 year

change of IHTG content in NAFLD assessed by ultrasound

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Winnie W.C. Chu

Professor

Chinese University of Hong Kong

研究点 (1)

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