Alternation of Non-alcoholic Fatty Liver Disease (NAFLD) and Cardiovascular Risks After Liftestyle Modification: A Ultrasound Attenuation Imaging-Based Study
Primary Purpose
Non-alcoholic Fatty Liver Disease
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Dietitian led life style modification intervention
Conventional care (control)
Sponsored by
About this trial
This is an interventional supportive care trial for Non-alcoholic Fatty Liver Disease focused on measuring Ultrasound Attenuation Imaging, NAFLD, cardiovascular risk, lifestyle modification
Eligibility Criteria
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.
Sites / Locations
- The Chinese University of Hong Kong, Prince of Wale HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
lifestyle modification program group
usual care group (control)
Arm Description
Outcomes
Primary Outcome Measures
intrahepatic triglycerides (IHTG) content
change of IHTG content in NAFLD assessed by ultrasound
cardiovascular risks
cardiovascular risks reflected by Intima-media thicknesses of both carotid arteries
Secondary Outcome Measures
Full Information
NCT ID
NCT04440540
First Posted
June 11, 2020
Last Updated
August 30, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04440540
Brief Title
Alternation of Non-alcoholic Fatty Liver Disease (NAFLD) and Cardiovascular Risks After Liftestyle Modification: A Ultrasound Attenuation Imaging-Based Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
Keywords
Ultrasound Attenuation Imaging, NAFLD, cardiovascular risk, lifestyle modification
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lifestyle modification program group
Arm Type
Experimental
Arm Title
usual care group (control)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Dietitian led life style modification intervention
Intervention Description
lifestyle changes supervised by dietitians
Intervention Type
Behavioral
Intervention Name(s)
Conventional care (control)
Intervention Description
receive routine care
Primary Outcome Measure Information:
Title
intrahepatic triglycerides (IHTG) content
Description
change of IHTG content in NAFLD assessed by ultrasound
Time Frame
1 year
Title
cardiovascular risks
Description
cardiovascular risks reflected by Intima-media thicknesses of both carotid arteries
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Winnie CW Chu, MD
Phone
3505 2299
Email
winniechu@cuhk.edu.hk
Facility Information:
Facility Name
The Chinese University of Hong Kong, Prince of Wale Hospital
City
Hong Kong
State/Province
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winnie CW Chu, MD
Phone
3505 2299
Email
winniechu@cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Alternation of Non-alcoholic Fatty Liver Disease (NAFLD) and Cardiovascular Risks After Liftestyle Modification: A Ultrasound Attenuation Imaging-Based Study
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