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

NCT04440540 | Terminated

• 1 other identifier: 2020.256
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Ultrasound Attenuation Imaging; NAFLD; cardiovascular risk; lifestyle modification

Outcome Measures

Primary Outcomes (2)

• intrahepatic triglycerides (IHTG) content

  change of IHTG content in NAFLD assessed by ultrasound

  1 year

• cardiovascular risks

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

  1 year

Study Arms (2)

lifestyle modification program group

EXPERIMENTAL

Behavioral: Dietitian led life style modification intervention

usual care group (control)

EXPERIMENTAL

Behavioral: Conventional care (control)

Interventions

Dietitian led life style modification intervention BEHAVIORAL

lifestyle changes supervised by dietitians

lifestyle modification program group

Conventional care (control) BEHAVIORAL

receive routine care

usual care group (control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong, Prince of Wale Hospital

Hong Kong, Shatin, Hong Kong

Location

Related Publications (12)

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  PMID: 29995306 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 19, 2020
• Study Start: July 2, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)