Steatohepatitis, NonalcoholicNCT04861012
Screening for Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD) at Al-Rajhy Hospital Nutrition Clinic. Assiut, Egypt
A study testing Ultrasound in people with Steatohepatitis, Nonalcoholic, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Steatohepatitis, Nonalcoholic
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-80 years
Who cannot join
- Pregnant females.
- Patients who will refuse to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Screening for Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD) at Al-Rajhy Hospital Nutrition Clinic
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).
Read the detailed description
Metabolic dysfunction-associated fatty liver disease (MAFLD) formly called non alcoholic fatty liver disease (NAFLD) was defined as the presence of macrovesicular steatosis in ≥5% of hepatocytes in individuals who consume little or no alcohol. NAFLD was divided into two major subtypes: nonalcoholic fatty liver, and Non alcoholic steatohepatitis (NASH).
It is now believed that MAFLD is due to state of systemic metabolic dysfunction and is perceived as standalone disease that warrants positive diagnosis rather than simply a disease of exclusion. MAFLD affects about quarter of the world's population and it is now considered a public health issue.
Real time ultrasound (US) scanning is accepted as the first line imaging investigation in patients with suspected liver disorders. In spite insufficient sensitivity to detect liver inflammation and fibrosis, it demonstrates a good correlation with histological finding of fatty infiltration.
Another tool used for detection of fatty liver is fatty liver index (FLI) which is an algorithm based on waist circumference, body mass index (BMI), triglyceride, and gamma-glutamyl-transferase (GGT). A FLI < 30 (negative likelihood ratio = 0.2) rules out and a FLI ≥ 60 (positive likelihood ratio = 4.3) rules in fatty liver. FLI had an accuracy of 0.84 (95% confidence interval (CI) 0.81-0.87) in detecting fatty liver.
Haung X, et al, 2015 found that FLI achieves a high sensitivity of 79.89% and a specificity of 71.51% for diagnosis of NAFLD.
TE (transient elastography) is a non-invasive ultrasound-based method that uses shear wave velocity to assess tissue (e.g., liver) stiffness. It has been applied in medical practice under the name FibroScan®.
Based on the physical characteristics (velocity and intensity attenuation) of the shear wave, the acquired data in the examination are processed and displayed on the screen as the liver stiffness measurement (LSM) and controlled attenuation parameter (CAP).
LSM values range from 1.5 to 75 kPa; lower values indicate a more elastic liver. CAP values range from 100 to 400 dB/m, and higher numbers indicate more pronounced steatosis.
A meta-analysis in 2014 has indicated that TE is excellent in diagnosing F ≥ 3 (85% sensitivity, 82% specificity) and F4 (92% sensitivity, 92% specificity), and it has a moderate accuracy for F ≥ 2 in NAFLD patients.
According to various studies, compared to liver biopsy, CAP is useful in the detection of S ≥ 1, S ≥ 2, and S3 (where S0 indicates no steatosis, to S3, which indicates the highest level of steatosis steatosis) because of its good sensitivity and specificity; however, the exact cut-off values remain to be defined.
Sample size estimation:
To assess the prevalence of MAFLD in, a prospective cross-sectional study was conducted. Based on previous studies (24), the expected frequency of MAFLD in Egypt is 37%. For a two-sided 95% confidence interval for a single proportion using the large sample normal approximation that will extend 5 % from the expected proportion, a sample size of 360 participant will be recruited. The sample will be equally represented from urban and rural areas. Sample size estimation was performed by Epi Info statistical package (Dean A, 1990).
Dean A (1990). Epi Info, Version 5.01. US Department of Health and Human Services, Public Health Service, Centers for Disease Control; 1990.
Statistical methods Data management and analysis will be performed using Statistical Package for Social Sciences (SPSS) vs. 25. Numerical data were summarized using means and standard deviations or medians, interquartile ranges and/or ranges, as appropriate. Categorical data were summarized as numbers and percentages. Estimates of the frequency of different grade of severity of NAFLD in the entire sample and will be done using the numbers and percentages. Numerical data were explored for normality using Kolmogrov-Smirnov test and Shapiro-Wilk test. The severity of fatty liver will be related to different serological risk factors of metabolic syndrome and diseases progression.
Chi square or Fisher's tests will be used to compare between the groups with respect to categorical data, as appropriate. Comparisons between two groups for normally distributed numeric variables will be done using the Student's t-test while for non-normally distributed numeric variables, comparisons will be done by Mann-Whitney test. Comparisons between more than 2 groups will be performed by the one analysis of variance (ANOVA) for normally distributed variables and Kruskal-Wallis for non-normally distributed variables, then followed by post hoc if needed. To measure the strength of association between the normally distributed numerical measurements, Pearson's correlation coefficients will be computed. Spearman's correlation coefficients will be calculated for non-normally distributed variables. All tests are two-sided. P-values < 0.05 is considered significant.
- Conditions
- Steatohepatitis, Nonalcoholic
- Being tested
- Ultrasound
- Keywords
- MAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Also called Fibroscan
All subjects initially will be subjected to abdominal ultrasound, and if fatty liver is detected fibroscan will be done
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (3)
determining the number of patients diagnosed as MAFLD and degree of fibrosis and steatosis in each one.
Fibro scan with CAP to all patients meeting criteria of MAFLD
Measured: baseline
Determining the rate of patients with other associated chronic liver disease(CLD)
Hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen will be done for all participants and history of any CLD
Measured: baseline
Determining the rate of obesity, DM, HTN, hyperlipidemia in patients with MAFLD
.Through history, clinical examination and lab tests.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Steatohepatitis, NonalcoholicStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Salah-eldin Amry Ahmad, Assiut University
- Investigators
- Sherif Kamel, Professor, Study director, Assiut UniversityMohammed Medhat, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861012
- Sponsor's protocol ID
- MAFLD Assiut
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Adams LA, Lymp JF, St Sauver J, Sanderson SO, Lindor KD, Feldstein A, Angulo P. The natural history of nonalcoholic fatty liver disease: a population-based cohort study. Gastroenterology. 2005 Jul;129(1):113-21. doi: 10.1053/j.gastro.2005.04.014.
PubMed 16012941Matteoni 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.
PubMed 10348825Eslam 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.
PubMed 32278004Younossi 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.
PubMed 28930295Sarin 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.
PubMed 31852635Hegazy 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.
PubMed 29699348Bedogni 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.
PubMed 17081293Huang 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.
PubMed 26448014Sandrin 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.
PubMed 14698338Castera 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.
PubMed 18334275Afdhal NH. Fibroscan (transient elastography) for the measurement of liver fibrosis. Gastroenterol Hepatol (N Y). 2012 Sep;8(9):605-7. No abstract available.
PubMed 23483859Sandrin 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.
PubMed 11989699Gennisson 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.
PubMed 23619292Sasso 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.
PubMed 21920839Kwok 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.
PubMed 24308774
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD) at Al-Rajhy Hospital Nutrition Clinic
- ClinicalTrials.gov ID
- NCT04861012
- Acronym / sponsor ID
- MAFLD Assiut
- Conditions
- Steatohepatitis, Nonalcoholic
- Keywords
- MAFLD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Metabolic dysfunction-associated fatty liver disease (MAFLD) formly called non alcoholic fatty liver disease (NAFLD) was defined as the presence of macrovesicular steatosis in ≥5% of hepatocytes in individuals who consume little or no alcohol. NAFLD was divided into two major subtypes: nonalcoholic fatty liver, and Non alcoholic steatohepatitis (NASH).
It is now believed that MAFLD is due to state of systemic metabolic dysfunction and is perceived as standalone disease that warrants positive diagnosis rather than simply a disease of exclusion. MAFLD affects about quarter of the world's population and it is now considered a public health issue.
Real time ultrasound (US) scanning is accepted as the first line imaging investigation in patients with suspected liver disorders. In spite insufficient sensitivity to detect liver inflammation and fibrosis, it demonstrates a good correlation with histological finding of fatty infiltration.
Another tool used for detection of fatty liver is fatty liver index (FLI) which is an algorithm based on waist circumference, body mass index (BMI), triglyceride, and gamma-glutamyl-transferase (GGT). A FLI < 30 (negative likelihood ratio = 0.2) rules out and a FLI ≥ 60 (positive likelihood ratio = 4.3) rules in fatty liver. FLI had an accuracy of 0.84 (95% confidence interval (CI) 0.81-0.87) in detecting fatty liver.
Haung X, et al, 2015 found that FLI achieves a high sensitivity of 79.89% and a specificity of 71.51% for diagnosis of NAFLD.
TE (transient elastography) is a non-invasive ultrasound-based method that uses shear wave velocity to assess tissue (e.g., liver) stiffness. It has been applied in medical practice under the name FibroScan®.
Based on the physical characteristics (velocity and intensity attenuation) of the shear wave, the acquired data in the examination are processed and displayed on the screen as the liver stiffness measurement (LSM) and controlled attenuation parameter (CAP).
LSM values range from 1.5 to 75 kPa; lower values indicate a more elastic liver. CAP values range from 100 to 400 dB/m, and higher numbers indicate more pronounced steatosis.
A meta-analysis in 2014 has indicated that TE is excellent in diagnosing F ≥ 3 (85% sensitivity, 82% specificity) and F4 (92% sensitivity, 92% specificity), and it has a moderate accuracy for F ≥ 2 in NAFLD patients.
According to various studies, compared to liver biopsy, CAP is useful in the detection of S ≥ 1, S ≥ 2, and S3 (where S0 indicates no steatosis, to S3, which indicates the highest level of steatosis steatosis) because of its good sensitivity and specificity; however, the exact cut-off values remain to be defined.
Sample size estimation:
To assess the prevalence of MAFLD in, a prospective cross-sectional study was conducted. Based on previous studies (24), the expected frequency of MAFLD in Egypt is 37%. For a two-sided 95% confidence interval for a single proportion using the large sample normal approximation that will extend 5 % from the expected proportion, a sample size of 360 participant will be recruited. The sample will be equally represented from urban and rural areas. Sample size estimation was performed by Epi Info statistical package (Dean A, 1990).
Dean A (1990). Epi Info, Version 5.01. US Department of Health and Human Services, Public Health Service, Centers for Disease Control; 1990.
Statistical methods Data management and analysis will be performed using Statistical Package for Social Sciences (SPSS) vs. 25. Numerical data were summarized using means and standard deviations or medians, interquartile ranges and/or ranges, as appropriate. Categorical data were summarized as numbers and percentages. Estimates of the frequency of different grade of severity of NAFLD in the entire sample and will be done using the numbers and percentages. Numerical data were explored for normality using Kolmogrov-Smirnov test and Shapiro-Wilk test. The severity of fatty liver will be related to different serological risk factors of metabolic syndrome and diseases progression.
Chi square or Fisher's tests will be used to compare between the groups with respect to categorical data, as appropriate. Comparisons between two groups for normally distributed numeric variables will be done using the Student's t-test while for non-normally distributed numeric variables, comparisons will be done by Mann-Whitney test. Comparisons between more than 2 groups will be performed by the one analysis of variance (ANOVA) for normally distributed variables and Kruskal-Wallis for non-normally distributed variables, then followed by post hoc if needed. To measure the strength of association between the normally distributed numerical measurements, Pearson's correlation coefficients will be computed. Spearman's correlation coefficients will be calculated for non-normally distributed variables. All tests are two-sided. P-values < 0.05 is considered significant.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age: 18-80 years
Key exclusion criteria (2 listed)
- Pregnant females.
- Patients who will refuse to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundAlso: FibroscanAll subjects initially will be subjected to abdominal ultrasound, and if fatty liver is detected fibroscan will be done | Device | – |
Primary outcome
Screen for MAFLD among patients attending to the Nutrition clinic in Al Rajhi hospital
Time frame: baseline
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
3 secondary outcomes
determining the number of patients diagnosed as MAFLD and degree of fibrosis and steatosis in each one.
Time frame: baseline
Determining the rate of patients with other associated chronic liver disease(CLD)
Time frame: baseline
Determining the rate of obesity, DM, HTN, hyperlipidemia in patients with MAFLD
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 16012941Adams LA, Lymp JF, St Sauver J, Sanderson SO, Lindor KD, Feldstein A, Angulo P. The natural history of nonalcoholic fatty liver disease: a population-based cohort study. Gastroenterology. 2005 Jul;129(1):113-21. doi: 10.1053/j.gastro.2005.04.014.
- Background: PubMed 10348825Matteoni 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.
- Background: PubMed 32278004Eslam 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.
- Background: PubMed 28930295Younossi 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.
- Background: PubMed 31852635Sarin 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.
- Background: PubMed 29699348Hegazy 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.
- Background: PubMed 17081293Bedogni 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.
- Background: PubMed 26448014Huang 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.
- Background: PubMed 14698338Sandrin 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.
- Background: PubMed 18334275Castera 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.
- Background: PubMed 23483859Afdhal NH. Fibroscan (transient elastography) for the measurement of liver fibrosis. Gastroenterol Hepatol (N Y). 2012 Sep;8(9):605-7. No abstract available.
- Background: PubMed 11989699Sandrin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherif Kamel, Professor study director
Assiut University
Mohammed Medhat, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Steatohepatitis, Nonalcoholic, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yusuf Amry, Resident (00201068160066, yusufamry@rocketmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screen for MAFLD among patients attending to the Nutrition clinic in Al Rajhi hospital (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04861012, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.