Screening for Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD) at Al-Rajhy Hospital Nutrition Clinic. Assiut, Egypt
1 other identifier
interventional
360
0 countries
N/A
Brief Summary
Primary outcome Screen for MAFLD among patients attending to the Nutrition clinic in Al Rajhi hospital. Secondary outcome
- Determining the degrees of fibrosis and steatosis in patients with MAFLD
- Determining the rate of obesity, diabetes mellitus (DM), hypertension (HTN), hyperlipidemia in patients with MAFLD.
- Determining the rate of patients with other associated chronic liver disease (CLD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2021
CompletedFirst Posted
Study publicly available on registry
April 27, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedApril 27, 2021
April 1, 2021
1 year
April 20, 2021
April 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Screen for MAFLD among patients attending to the Nutrition clinic in Al Rajhi hospital
Screening will be done according to new criteria set by Eslam M, et al, 2020, Patients with detected fatty liver by ultrasound will undergo an evaluation for the BMI and fasting and post prandial blood glucose levels. Patients with with BMI \>25 kg/m2 or type two diabetes mellitus (DM) will be diagnosed to have MAFLD. Patients with BMI \< 25 kg/m2 and normal sugar curve will be subjected to tests to detect metabolic abnormalities with the presence of at least two metabolic risk abnormalities, the subject will be diagnosed as MAFLD. Eventually the percentage of patients diagnosed as MAFLD will be calculated among this random sample
baseline
Secondary Outcomes (3)
determining the number of patients diagnosed as MAFLD and degree of fibrosis and steatosis in each one.
baseline
Determining the rate of patients with other associated chronic liver disease(CLD)
baseline
Determining the rate of obesity, DM, HTN, hyperlipidemia in patients with MAFLD
baseline
Interventions
All subjects initially will be subjected to abdominal ultrasound, and if fatty liver is detected fibroscan will be done
Eligibility Criteria
You may qualify if:
- Age: 18-80 years
You may not qualify if:
- Pregnant females.
- Patients who will refuse to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (23)
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PMID: 16012941BACKGROUNDMatteoni CA, Younossi ZM, Gramlich T, Boparai N, Liu YC, McCullough AJ. Nonalcoholic fatty liver disease: a spectrum of clinical and pathological severity. Gastroenterology. 1999 Jun;116(6):1413-9. doi: 10.1016/s0016-5085(99)70506-8.
PMID: 10348825BACKGROUNDEslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.
PMID: 32278004BACKGROUNDYounossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, George J, Bugianesi E. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol. 2018 Jan;15(1):11-20. doi: 10.1038/nrgastro.2017.109. Epub 2017 Sep 20.
PMID: 28930295BACKGROUNDSarin SK, Kumar M, Eslam M, George J, Al Mahtab M, Akbar SMF, Jia J, Tian Q, Aggarwal R, Muljono DH, Omata M, Ooka Y, Han KH, Lee HW, Jafri W, Butt AS, Chong CH, Lim SG, Pwu RF, Chen DS. Liver diseases in the Asia-Pacific region: a Lancet Gastroenterology & Hepatology Commission. Lancet Gastroenterol Hepatol. 2020 Feb;5(2):167-228. doi: 10.1016/S2468-1253(19)30342-5. Epub 2019 Dec 15.
PMID: 31852635BACKGROUNDHegazy M, Abo-Elfadl S, Mostafa A, Ibrahim M, Rashed L, Salman A. Serum Resistin Level and Its Receptor Gene Expression in Liver Biopsy as Predictors for the Severity of Nonalcoholic Fatty Liver Disease. Euroasian J Hepatogastroenterol. 2014 Jul-Dec;4(2):59-62. doi: 10.5005/jp-journals-10018-1102i. Epub 2014 Jul 28.
PMID: 29699348BACKGROUNDBedogni G, Bellentani S, Miglioli L, Masutti F, Passalacqua M, Castiglione A, Tiribelli C. The Fatty Liver Index: a simple and accurate predictor of hepatic steatosis in the general population. BMC Gastroenterol. 2006 Nov 2;6:33. doi: 10.1186/1471-230X-6-33.
PMID: 17081293BACKGROUNDHuang X, Xu M, Chen Y, Peng K, Huang Y, Wang P, Ding L, Lin L, Xu Y, Chen Y, Lu J, Wang W, Bi Y, Ning G. Validation of the Fatty Liver Index for Nonalcoholic Fatty Liver Disease in Middle-Aged and Elderly Chinese. Medicine (Baltimore). 2015 Oct;94(40):e1682. doi: 10.1097/MD.0000000000001682.
PMID: 26448014BACKGROUNDSandrin L, Fourquet B, Hasquenoph JM, Yon S, Fournier C, Mal F, Christidis C, Ziol M, Poulet B, Kazemi F, Beaugrand M, Palau R. Transient elastography: a new noninvasive method for assessment of hepatic fibrosis. Ultrasound Med Biol. 2003 Dec;29(12):1705-13. doi: 10.1016/j.ultrasmedbio.2003.07.001.
PMID: 14698338BACKGROUNDCastera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008 May;48(5):835-47. doi: 10.1016/j.jhep.2008.02.008. Epub 2008 Feb 26.
PMID: 18334275BACKGROUNDAfdhal NH. Fibroscan (transient elastography) for the measurement of liver fibrosis. Gastroenterol Hepatol (N Y). 2012 Sep;8(9):605-7. No abstract available.
PMID: 23483859BACKGROUNDSandrin L, Tanter M, Gennisson JL, Catheline S, Fink M. Shear elasticity probe for soft tissues with 1-D transient elastography. IEEE Trans Ultrason Ferroelectr Freq Control. 2002 Apr;49(4):436-46. doi: 10.1109/58.996561.
PMID: 11989699BACKGROUNDGennisson JL, Deffieux T, Fink M, Tanter M. Ultrasound elastography: principles and techniques. Diagn Interv Imaging. 2013 May;94(5):487-95. doi: 10.1016/j.diii.2013.01.022. Epub 2013 Apr 22.
PMID: 23619292BACKGROUNDSasso M, Miette V, Sandrin L, Beaugrand M. The controlled attenuation parameter (CAP): a novel tool for the non-invasive evaluation of steatosis using Fibroscan. Clin Res Hepatol Gastroenterol. 2012 Feb;36(1):13-20. doi: 10.1016/j.clinre.2011.08.001. Epub 2011 Sep 15.
PMID: 21920839BACKGROUNDKwok R, Tse YK, Wong GL, Ha Y, Lee AU, Ngu MC, Chan HL, Wong VW. Systematic review with meta-analysis: non-invasive assessment of non-alcoholic fatty liver disease--the role of transient elastography and plasma cytokeratin-18 fragments. Aliment Pharmacol Ther. 2014 Feb;39(3):254-69. doi: 10.1111/apt.12569. Epub 2013 Dec 5.
PMID: 24308774BACKGROUNDSasso M, Beaugrand M, de Ledinghen V, Douvin C, Marcellin P, Poupon R, Sandrin L, Miette V. Controlled attenuation parameter (CAP): a novel VCTE guided ultrasonic attenuation measurement for the evaluation of hepatic steatosis: preliminary study and validation in a cohort of patients with chronic liver disease from various causes. Ultrasound Med Biol. 2010 Nov;36(11):1825-35. doi: 10.1016/j.ultrasmedbio.2010.07.005. Epub 2010 Sep 27.
PMID: 20870345BACKGROUNDImajo K, Kessoku T, Honda Y, Tomeno W, Ogawa Y, Mawatari H, Fujita K, Yoneda M, Taguri M, Hyogo H, Sumida Y, Ono M, Eguchi Y, Inoue T, Yamanaka T, Wada K, Saito S, Nakajima A. Magnetic Resonance Imaging More Accurately Classifies Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease Than Transient Elastography. Gastroenterology. 2016 Mar;150(3):626-637.e7. doi: 10.1053/j.gastro.2015.11.048. Epub 2015 Dec 8.
PMID: 26677985BACKGROUNDMyers RP, Pollett A, Kirsch R, Pomier-Layrargues G, Beaton M, Levstik M, Duarte-Rojo A, Wong D, Crotty P, Elkashab M. Controlled Attenuation Parameter (CAP): a noninvasive method for the detection of hepatic steatosis based on transient elastography. Liver Int. 2012 Jul;32(6):902-10. doi: 10.1111/j.1478-3231.2012.02781.x. Epub 2012 Mar 21.
PMID: 22435761BACKGROUNDde Ledinghen V, Vergniol J, Foucher J, Merrouche W, le Bail B. Non-invasive diagnosis of liver steatosis using controlled attenuation parameter (CAP) and transient elastography. Liver Int. 2012 Jul;32(6):911-8. doi: 10.1111/j.1478-3231.2012.02820.x.
PMID: 22672642BACKGROUNDKumar M, Rastogi A, Singh T, Behari C, Gupta E, Garg H, Kumar R, Bhatia V, Sarin SK. Controlled attenuation parameter for non-invasive assessment of hepatic steatosis: does etiology affect performance? J Gastroenterol Hepatol. 2013 Jul;28(7):1194-201. doi: 10.1111/jgh.12134.
PMID: 23425053BACKGROUNDShen F, Zheng RD, Mi YQ, Wang XY, Pan Q, Chen GY, Cao HX, Chen ML, Xu L, Chen JN, Cao Y, Zhang RN, Xu LM, Fan JG. Controlled attenuation parameter for non-invasive assessment of hepatic steatosis in Chinese patients. World J Gastroenterol. 2014 Apr 28;20(16):4702-11. doi: 10.3748/wjg.v20.i16.4702.
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PMID: 24548002BACKGROUNDLupsor-Platon M, Feier D, Stefanescu H, Tamas A, Botan E, Sparchez Z, Maniu A, Badea R. Diagnostic accuracy of controlled attenuation parameter measured by transient elastography for the non-invasive assessment of liver steatosis: a prospective study. J Gastrointestin Liver Dis. 2015 Mar;24(1):35-42. doi: 10.15403/jgld.2014.1121.mlp.
PMID: 25822432BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sherif Kamel, Professor
Assiut University
- STUDY DIRECTOR
Mohammed Medhat, Lecturer
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
April 20, 2021
First Posted
April 27, 2021
Study Start
September 1, 2021
Primary Completion
September 1, 2022
Study Completion
December 1, 2022
Last Updated
April 27, 2021
Record last verified: 2021-04