Alternation of Non-alcoholic Fatty Liver Disease (NAFLD) and Cardiovascular Risks After Liftestyle Modification: A Ultrasound Attenuation Imaging-Based Study
NCT ID: NCT04440540
Last Updated: 2024-02-07
Study Results
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Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2020-07-02
2023-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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lifestyle modification program group
Dietitian led life style modification intervention
lifestyle changes supervised by dietitians
usual care group (control)
Conventional care (control)
receive routine care
Interventions
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Dietitian led life style modification intervention
lifestyle changes supervised by dietitians
Conventional care (control)
receive routine care
Eligibility Criteria
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Inclusion Criteria
* With diagnosis of NAFLD.
* BMI =27.5- 32.4kg/m2 for moderate obesity (Asian population)
* Written consent form obtained.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Professor Winnie W.C. Chu
Professor
Locations
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The Chinese University of Hong Kong, Prince of Wale Hospital
Hong Kong, Shatin, Hong Kong
Countries
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References
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Carbone S, Canada JM, Billingsley HE, Siddiqui MS, Elagizi A, Lavie CJ. Obesity paradox in cardiovascular disease: where do we stand? Vasc Health Risk Manag. 2019 May 1;15:89-100. doi: 10.2147/VHRM.S168946. eCollection 2019.
Szczepaniak LS, Nurenberg P, Leonard D, Browning JD, Reingold JS, Grundy S, Hobbs HH, Dobbins RL. Magnetic resonance spectroscopy to measure hepatic triglyceride content: prevalence of hepatic steatosis in the general population. Am J Physiol Endocrinol Metab. 2005 Feb;288(2):E462-8. doi: 10.1152/ajpendo.00064.2004. Epub 2004 Aug 31.
Wong VW, Wong GL, Yeung DK, Lau TK, Chan CK, Chim AM, Abrigo JM, Chan RS, Woo J, Tse YK, Chu WC, Chan HL. Incidence of non-alcoholic fatty liver disease in Hong Kong: a population study with paired proton-magnetic resonance spectroscopy. J Hepatol. 2015 Jan;62(1):182-9. doi: 10.1016/j.jhep.2014.08.041. Epub 2014 Sep 6.
Wong VW, Chu WC, Wong GL, Chan RS, Chim AM, Ong A, Yeung DK, Yiu KK, Chu SH, Woo J, Chan FK, Chan HL. Prevalence of non-alcoholic fatty liver disease and advanced fibrosis in Hong Kong Chinese: a population study using proton-magnetic resonance spectroscopy and transient elastography. Gut. 2012 Mar;61(3):409-15. doi: 10.1136/gutjnl-2011-300342. Epub 2011 Aug 16.
Wei JL, Leung JC, Loong TC, Wong GL, Yeung DK, Chan RS, Chan HL, Chim AM, Woo J, Chu WC, Wong VW. Prevalence and Severity of Nonalcoholic Fatty Liver Disease in Non-Obese Patients: A Population Study Using Proton-Magnetic Resonance Spectroscopy. Am J Gastroenterol. 2015 Sep;110(9):1306-14; quiz 1315. doi: 10.1038/ajg.2015.235. Epub 2015 Jul 28.
Mantovani A, Zaza G, Byrne CD, Lonardo A, Zoppini G, Bonora E, Targher G. Nonalcoholic fatty liver disease increases risk of incident chronic kidney disease: A systematic review and meta-analysis. Metabolism. 2018 Feb;79:64-76. doi: 10.1016/j.metabol.2017.11.003. Epub 2017 Nov 11.
Mantovani A, Byrne CD, Bonora E, Targher G. Nonalcoholic Fatty Liver Disease and Risk of Incident Type 2 Diabetes: A Meta-analysis. Diabetes Care. 2018 Feb;41(2):372-382. doi: 10.2337/dc17-1902.
Targher G, Byrne CD, Lonardo A, Zoppini G, Barbui C. Non-alcoholic fatty liver disease and risk of incident cardiovascular disease: A meta-analysis. J Hepatol. 2016 Sep;65(3):589-600. doi: 10.1016/j.jhep.2016.05.013. Epub 2016 May 17.
Liu Y, Zhong GC, Tan HY, Hao FB, Hu JJ. Nonalcoholic fatty liver disease and mortality from all causes, cardiovascular disease, and cancer: a meta-analysis. Sci Rep. 2019 Jul 31;9(1):11124. doi: 10.1038/s41598-019-47687-3.
Akil L, Ahmad HA. Relationships between obesity and cardiovascular diseases in four southern states and Colorado. J Health Care Poor Underserved. 2011;22(4 Suppl):61-72. doi: 10.1353/hpu.2011.0166.
Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available.
Unamuno X, Gomez-Ambrosi J, Rodriguez A, Becerril S, Fruhbeck G, Catalan V. Adipokine dysregulation and adipose tissue inflammation in human obesity. Eur J Clin Invest. 2018 Sep;48(9):e12997. doi: 10.1111/eci.12997. Epub 2018 Aug 3.
Other Identifiers
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2020.256
Identifier Type: -
Identifier Source: org_study_id
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