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Clinical Trials/NCT04440540
NCT04440540TerminatedNot Applicable

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 site in 1 country10 target enrollmentStarted: July 2, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
10
Locations
1
Primary Endpoint
cardiovascular risks

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

lifestyle modification program group

Experimental

Intervention: Dietitian led life style modification intervention (Behavioral)

usual care group (control)

Experimental

Intervention: Conventional care (control) (Behavioral)

Outcomes

Primary Outcomes

cardiovascular risks

Time Frame: 1 year

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

intrahepatic triglycerides (IHTG) content

Time Frame: 1 year

change of IHTG content in NAFLD assessed by ultrasound

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Professor Winnie W.C. Chu

Professor

Chinese University of Hong Kong

Study Sites (1)

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