NAFLDNCT04081571
Prevalence of NAFLD and Correlation With Its Main Risk Factors Among Egyptian
An observational study of NAFLD and Insulin Resistance, run by Cairo University at 1 site in Egypt.
Trial summary
Getting a rough indicator about the prevalence of different grade of severity of NAFLD (NASH \& liver fibrosis), and Correlate the severity of fatty liver with different serological risk factors of metabolic syndrome and diseases progression as well as the prevalence of hepatocellular carcinoma related to NAFLD with… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- NAFLD, Insulin Resistance, Hepatic Steatosis
- How many people
- 1,080 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to Oct 2023
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study is a prospective cross-sectional Multicenter National study, including 1080 participants with BMI ≥ 24kg/m diagnosed with a high probability of NAFLD using ultrasound with or without elevated liver enzymes
Who may be able to join
- Participants with following criteria: age: 18-60 years and both sexes
- Any participant with BMI more than or equal to 24kg/m2 (overweight and obese according to Chinese cut off values)
Who cannot join
- Any hepatic diseases including e.g. Hepatitis C, Hepatitis B, autoimmune hepatitis
- Pregnant females
- Alcohol intake
- Antibiotic use within the previous 3 months
- Patients had acute or chronic health diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Cairo University
Cairo
Mona A Hegazy, MD, 0201001421551, monahegazy@cu.edu.eg
Ahmed M Abdul Ghani, MD, 0201005150375, Abdelgany@staff.cu.edu.eg
About this study
Official title: Prevalence of NAFLD and Correlation With Its Main Risk Factors Among Egyptian Multicenter National Study
Getting a rough indicator about the prevalence of different grade of severity of NAFLD (NASH \& liver fibrosis), and Correlate the severity of fatty liver with different serological risk factors of metabolic syndrome and diseases progression as well as the prevalence of hepatocellular carcinoma related to NAFLD with the use of ; nutritional assessment designed and conducted by the investigators in this research, simple blood test (lipid profile and blood sugar), and easy cheap non-invasive radiological tool as screening to predict NASH.
Read the detailed description
This study is a prospective cross-sectional Multicenter National study, will include 1080 participants with BMI ≥ 24kg/m 2 with or without elevated liver enzymes. All will be subjected to; dietary history by already prepared food quality and quantity questionnaire, anthropometric data (BMI \& waist circumference), Clinical examination, Laboratory work include: total lipid profile (LDL-C, HDL-C, VLDL (very low-density lipoprotein)\& TGs (Triglyceride)), fasting blood glucose and insulin (HOMA-IR (Insulin Resistance) will be calculated), HbA1c%, liver biochemistry tests (ALT, GGT (Gammaglutamyl transpeptidase), AST (aspartate aminotransferase), and bilirubin), Liver function testes (INR \& albumin), HCV (Hepatitis C virus) antibody, HBV (Hepatitis B virus) surface antigen, TSH (thyroid-stimulating hormone) , Free T3 \& T4 will be done for all participants. Imaging; Liver ultrasound including measurement of the subcutaneous fat in front of the left lobe of liver as well as at the umbilical region and assessment of liver stiffness by Fibroscan.
The novelty of this study is that, if it showed a successful outcome, the investigators will get a rough indicator about the prevalence of different grade of severity of NAFLD, and Correlate the severity of fatty liver with different risk factors of metabolic syndrome and life style modifications among Egyptians, and trying to confirm the great variability between different races regarding BMI classes and overweight \& obesity cut-off values, confirming the high level of insulin resistance in non-diabetic participants with NAFLD compared to other races, identify types of food that are at risk for development and progression of NAFLD thus getting a healthy food recommendations for Egyptians and get a recommendation for another studies for metabolic syndrome redefinition with NAFLD part of it (not just considering as known in the present time), and working on the Triglycerides, LDL, and HDL cut off values. investigators also hope through this research to modify dietary habits in the Egyptian society encouraging healthy nutrition through dietary assessment (already prepared food quality and quantity questionnaire), that can lead to not only NAFLD but also progress to NASH, so participants can promote healthy dietary habits and proper life style among different health care providers thus decreasing incidence of obesity, one of main risk factors of fatty liver diseases and its consequences especially Hepatocellular Cancer.
Investigators also hope through this research to modify dietary habits in the Egyptian society encouraging healthy nutrition through promoting professional nutritional assessment and questionnaire among different health care providers thus decreasing incidence of obesity, one of main risk factors of fatty liver diseases and its consequences especially Hepatocellular Cancer.
- Conditions
- NAFLD, Insulin Resistance, Hepatic Steatosis
- Keywords
- NAFLD, Insulin Resistance, Hepatic Steatosis, EGYPTIAN
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Insulin Resistance, Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of different grads of severity of NAFLD and Correlation with Its main risk Factors among Egyptians
In the Middle East, till the present time, no data about the incidence, prevalence of NAFLD early identification of patients with NASH prior to the onset of advanced fibrosis would be helpful in guiding aggressive interaction.
Measured: April 2019 to March 2021
Dietary history
Food Frequency Checklist will be done. Mean daily consumption of selected food items will be calculated
Optimal level of intake and optimal range of intake :
- Fruits: 250 g (200-300) per day
- Vegetables:360 g (290-430) per day
- Grains:125 g (100-150) per day
- Legumes : 60 g (50-70) per day
- Milk \& milk products: 435 g (350-520) per day
- Sodium: 3 g (1-5) per day
- Sugar \& sweetened products:3 g (0-5) per day
- Meats : 23 g (18-27) per day)
- Processed meat:2 g (0-4) per day
- Sea foods \& omega 3 fatty acids : 250 mg (200-300) per day
- Nuts \&seeds :21 g (16-25) per day
- Polyunsaturated oils :11% (9-13) of total daily energy
- Trans fat-margarine :0·5% (0·0-1·0) of total daily energy
- Dietary fibers :24 g (19-28) per day
- Calcium :1,25 g(1,00-1.5g) per day
Measured: April 2019 to March 2021
Risk factors of NAFLD
The prevalence of NAFLD has risen rapidly in parallel with the dramatic rise in population levels of obesity and diabetes and the entire world follow the European BMI classification and the parameters for metabolic syndrome diagnosis, except for the modification done by china.
Measured: April 2019 to March 2021
Secondary outcomes (4)
Prevalence of NAFLD among different ethnic groups
Trying to confirm the great variability between different races regarding BMI classes and overweight \& obesity cut-off values
Measured: April 2019 to March 2020
Prevalence of Insulin resistance
Confirming the high level of insulin resistance in non-diabetic compared to other races
Measured: April 2019 to March 2020
Prevalence of Metabolic syndrome
if all the patients diagnosed as have metabolic syndrome according to international criteria, have NAFLD. Also the results of the present study will cover the cut of value of waist circumference in criteria of metabolic syndrome and the present study will show that those cut-of applied on Egyptians or not. So a recommendation for another studies for metabolic syndrome redefinition with NAFLD part of it (not just considering as known in the present time), and working on the Triglycerides, HDL cut off values \& changing blood sugar with the HOMA-IR (Homeostatic model assessment-insulin resistance) in Egyptians will be one of the present study expected outcomes recommendation
Measured: April 2019 to March 2020
NASH staging
Trying to get a cut-off value for LSFT (subcutaneous fat in front of left lobe of liver) and USFT (subcutaneous fat at umbilical region) as the investigators previous published work concluded that: LSFT, and USFT had high sensitivity and specificity as simple non-invasive screening method to identify the presence of NASH as prediction of NAFLD progression, so working on a large scale study as a novel method for easy identification and staging of NAFLD.
Measured: April 2019 to March 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Apr 2019
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University, Mansoura University, Alexandria University, Fayoum University, Tanta University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mona Hegazy, Cairo University
- Investigators
- Mona A Hegazy, MD, Principal investigator, Professor of Internal Medicine Hepatology, Faculty of medicine, Cairo UniversityAhmed M Abdul Ghani, MD, Study director, Lecturer of Internal Medicine & Hepatology, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081571
- Sponsor's protocol ID
- 1001
- Other IDs
- N-41-2019
- Status last verified
- Mar 2022
- First submitted
- 30 Jul 2019
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vuppalanchi R, Chalasani N. Nonalcoholic fatty liver disease and nonalcoholic steatohepatitis: Selected practical issues in their evaluation and management. Hepatology. 2009 Jan;49(1):306-17. doi: 10.1002/hep.22603.
PubMed 19065650de Alwis NM, Day CP. Non-alcoholic fatty liver disease: the mist gradually clears. J Hepatol. 2008;48 Suppl 1:S104-12. doi: 10.1016/j.jhep.2008.01.009. Epub 2008 Feb 4.
PubMed 18304679Marchesini G, Moscatiello S, Agostini F, Villanova N, Festi D. Treatment of non-alcoholic fatty liver disease with focus on emerging drugs. Expert Opin Emerg Drugs. 2011 Mar;16(1):121-36. doi: 10.1517/14728214.2011.531700.
PubMed 21352073Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.
PubMed 24042449Smith BW, Adams LA. Non-alcoholic fatty liver disease. Crit Rev Clin Lab Sci. 2011 May-Jun;48(3):97-113. doi: 10.3109/10408363.2011.596521.
PubMed 21875310Zhan Y, Zhao F, Xie P, Zhong L, Li D, Gai Q, Li L, Wei H, Zhang L, An W. Mechanism of the effect of glycosyltransferase GLT8D2 on fatty liver. Lipids Health Dis. 2015 May 8;14:43. doi: 10.1186/s12944-015-0040-3.
PubMed 25952508White DL, Kanwal F, El-Serag HB. Association between nonalcoholic fatty liver disease and risk for hepatocellular cancer, based on systematic review. Clin Gastroenterol Hepatol. 2012 Dec;10(12):1342-1359.e2. doi: 10.1016/j.cgh.2012.10.001. Epub 2012 Oct 4.
PubMed 23041539Lazo M, Clark JM. The epidemiology of nonalcoholic fatty liver disease: a global perspective. Semin Liver Dis. 2008 Nov;28(4):339-50. doi: 10.1055/s-0028-1091978. Epub 2008 Oct 27.
PubMed 18956290Zhou B; Coorperative Meta-Analysis Group Of Working Group On Obesity In China. [Prospective study for cut-off points of body mass index in Chinese adults]. Zhonghua Liu Xing Bing Xue Za Zhi. 2002 Dec;23(6):431-4. Chinese.
PubMed 12667353Omagari K, Kadokawa Y, Masuda J, Egawa I, Sawa T, Hazama H, Ohba K, Isomoto H, Mizuta Y, Hayashida K, Murase K, Kadota T, Murata I, Kohno S. Fatty liver in non-alcoholic non-overweight Japanese adults: incidence and clinical characteristics. J Gastroenterol Hepatol. 2002 Oct;17(10):1098-105. doi: 10.1046/j.1440-1746.2002.02846.x.
PubMed 12201871Fan JG, Farrell GC. Epidemiology of non-alcoholic fatty liver disease in China. J Hepatol. 2009 Jan;50(1):204-10. doi: 10.1016/j.jhep.2008.10.010. Epub 2008 Nov 6.
PubMed 19014878Lee JY, Kim KM, Lee SG, Yu E, Lim YS, Lee HC, Chung YH, Lee YS, Suh DJ. Prevalence and risk factors of non-alcoholic fatty liver disease in potential living liver donors in Korea: a review of 589 consecutive liver biopsies in a single center. J Hepatol. 2007 Aug;47(2):239-44. doi: 10.1016/j.jhep.2007.02.007. Epub 2007 Mar 6.
PubMed 17400323Heron M. Deaths: Leading Causes for 2014. Natl Vital Stat Rep. 2016 Jun;65(5):1-96.
PubMed 27376998Guerrero R, Vega GL, Grundy SM, Browning JD. Ethnic differences in hepatic steatosis: an insulin resistance paradox? Hepatology. 2009 Mar;49(3):791-801. doi: 10.1002/hep.22726.
PubMed 19105205Pan JJ, Fallon MB. Gender and racial differences in nonalcoholic fatty liver disease. World J Hepatol. 2014 May 27;6(5):274-83. doi: 10.4254/wjh.v6.i5.274.
PubMed 24868321
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of NAFLD and Correlation With Its Main Risk Factors Among Egyptian Multicenter National Study
- ClinicalTrials.gov ID
- NCT04081571
- Acronym / sponsor ID
- 1001
- Conditions
- NAFLD, Insulin Resistance, Hepatic Steatosis
- Keywords
- NAFLD, Insulin Resistance, Hepatic Steatosis, EGYPTIAN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Ain Shams University, Mansoura University, Alexandria University, Fayoum University, Tanta University, National Cancer Institute (NCI)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 9 Sep 2019 (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.
Getting a rough indicator about the prevalence of different grade of severity of NAFLD (NASH \& liver fibrosis), and Correlate the severity of fatty liver with different serological risk factors of metabolic syndrome and diseases progression as well as the prevalence of hepatocellular carcinoma related to NAFLD with the use of ; nutritional assessment designed and conducted by the investigators in this research, simple blood test (lipid profile and blood sugar), and easy cheap non-invasive radiological tool as screening to predict NASH.
Detailed description
This study is a prospective cross-sectional Multicenter National study, will include 1080 participants with BMI ≥ 24kg/m 2 with or without elevated liver enzymes. All will be subjected to; dietary history by already prepared food quality and quantity questionnaire, anthropometric data (BMI \& waist circumference), Clinical examination, Laboratory work include: total lipid profile (LDL-C, HDL-C, VLDL (very low-density lipoprotein)\& TGs (Triglyceride)), fasting blood glucose and insulin (HOMA-IR (Insulin Resistance) will be calculated), HbA1c%, liver biochemistry tests (ALT, GGT (Gammaglutamyl transpeptidase), AST (aspartate aminotransferase), and bilirubin), Liver function testes (INR \& albumin), HCV (Hepatitis C virus) antibody, HBV (Hepatitis B virus) surface antigen, TSH (thyroid-stimulating hormone) , Free T3 \& T4 will be done for all participants. Imaging; Liver ultrasound including measurement of the subcutaneous fat in front of the left lobe of liver as well as at the umbilical region and assessment of liver stiffness by Fibroscan.
The novelty of this study is that, if it showed a successful outcome, the investigators will get a rough indicator about the prevalence of different grade of severity of NAFLD, and Correlate the severity of fatty liver with different risk factors of metabolic syndrome and life style modifications among Egyptians, and trying to confirm the great variability between different races regarding BMI classes and overweight \& obesity cut-off values, confirming the high level of insulin resistance in non-diabetic participants with NAFLD compared to other races, identify types of food that are at risk for development and progression of NAFLD thus getting a healthy food recommendations for Egyptians and get a recommendation for another studies for metabolic syndrome redefinition with NAFLD part of it (not just considering as known in the present time), and working on the Triglycerides, LDL, and HDL cut off values. investigators also hope through this research to modify dietary habits in the Egyptian society encouraging healthy nutrition through dietary assessment (already prepared food quality and quantity questionnaire), that can lead to not only NAFLD but also progress to NASH, so participants can promote healthy dietary habits and proper life style among different health care providers thus decreasing incidence of obesity, one of main risk factors of fatty liver diseases and its consequences especially Hepatocellular Cancer.
Investigators also hope through this research to modify dietary habits in the Egyptian society encouraging healthy nutrition through promoting professional nutritional assessment and questionnaire among different health care providers thus decreasing incidence of obesity, one of main risk factors of fatty liver diseases and its consequences especially Hepatocellular Cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study is a prospective cross-sectional Multicenter National study, including 1080 participants with BMI ≥ 24kg/m diagnosed with a high probability of NAFLD using ultrasound with or without elevated liver enzymes
Key inclusion criteria (2 listed)
- Participants with following criteria: age: 18-60 years and both sexes
- Any participant with BMI more than or equal to 24kg/m2 (overweight and obese according to Chinese cut off values)
Key exclusion criteria (5 listed)
- Any hepatic diseases including e.g. Hepatitis C, Hepatitis B, autoimmune hepatitis
- Pregnant females
- Alcohol intake
- Antibiotic use within the previous 3 months
- Patients had acute or chronic health diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of different grads of severity of NAFLD and Correlation with Its main risk Factors among Egyptians
Time frame: April 2019 to March 2021
In the Middle East, till the present time, no data about the incidence, prevalence of NAFLD early identification of patients with NASH prior to the onset of advanced fibrosis would be helpful in guiding aggressive interaction.
Dietary history
Time frame: April 2019 to March 2021
Food Frequency Checklist will be done. Mean daily consumption of selected food items will be calculated Optimal level of intake and optimal range of intake : 1. Fruits: 250 g (200-300) per day 2. Vegetables:360 g (290-430) per day 3. Grains:125 g (100-150) per day 4. Legumes : 60 g (50-70) per day 5. Milk \& milk products: 435 g (350-520) per day 6. Sodium: 3 g (1-5) per day 7. Sugar \& sweetened products:3 g (0-5) per day 8. Meats : 23 g (18-27) per day) 9. Processed meat:2 g (0-4) per day 10. Sea foods \& omega 3 fatty acids : 250 mg (200-300) per day 11. Nuts \&seeds :21 g (16-25) per day 12. Polyunsaturated oils :11% (9-13) of total daily energy 13. Trans fat-margarine :0·5% (0·0-1·0) of total daily energy 14. Dietary fibers :24 g (19-28) per day 15. Calcium :1,25 g(1,00-1.5g) per day
Risk factors of NAFLD
Time frame: April 2019 to March 2021
The prevalence of NAFLD has risen rapidly in parallel with the dramatic rise in population levels of obesity and diabetes and the entire world follow the European BMI classification and the parameters for metabolic syndrome diagnosis, except for the modification done by china.
4 secondary outcomes
Prevalence of NAFLD among different ethnic groups
Time frame: April 2019 to March 2020
Prevalence of Insulin resistance
Time frame: April 2019 to March 2020
Prevalence of Metabolic syndrome
Time frame: April 2019 to March 2020
NASH staging
Time frame: April 2019 to March 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Background: PubMed 19065650Vuppalanchi R, Chalasani N. Nonalcoholic fatty liver disease and nonalcoholic steatohepatitis: Selected practical issues in their evaluation and management. Hepatology. 2009 Jan;49(1):306-17. doi: 10.1002/hep.22603.
- Background: PubMed 18304679de Alwis NM, Day CP. Non-alcoholic fatty liver disease: the mist gradually clears. J Hepatol. 2008;48 Suppl 1:S104-12. doi: 10.1016/j.jhep.2008.01.009. Epub 2008 Feb 4.
- Background: PubMed 21352073Marchesini G, Moscatiello S, Agostini F, Villanova N, Festi D. Treatment of non-alcoholic fatty liver disease with focus on emerging drugs. Expert Opin Emerg Drugs. 2011 Mar;16(1):121-36. doi: 10.1517/14728214.2011.531700.
- Background: PubMed 24042449Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.
- Background: PubMed 21875310Smith BW, Adams LA. Non-alcoholic fatty liver disease. Crit Rev Clin Lab Sci. 2011 May-Jun;48(3):97-113. doi: 10.3109/10408363.2011.596521.
- Background: PubMed 25952508Zhan Y, Zhao F, Xie P, Zhong L, Li D, Gai Q, Li L, Wei H, Zhang L, An W. Mechanism of the effect of glycosyltransferase GLT8D2 on fatty liver. Lipids Health Dis. 2015 May 8;14:43. doi: 10.1186/s12944-015-0040-3.
- Background: PubMed 23041539White DL, Kanwal F, El-Serag HB. Association between nonalcoholic fatty liver disease and risk for hepatocellular cancer, based on systematic review. Clin Gastroenterol Hepatol. 2012 Dec;10(12):1342-1359.e2. doi: 10.1016/j.cgh.2012.10.001. Epub 2012 Oct 4.
- Background: PubMed 18956290Lazo M, Clark JM. The epidemiology of nonalcoholic fatty liver disease: a global perspective. Semin Liver Dis. 2008 Nov;28(4):339-50. doi: 10.1055/s-0028-1091978. Epub 2008 Oct 27.
- Background: PubMed 12667353Zhou B; Coorperative Meta-Analysis Group Of Working Group On Obesity In China. [Prospective study for cut-off points of body mass index in Chinese adults]. Zhonghua Liu Xing Bing Xue Za Zhi. 2002 Dec;23(6):431-4. Chinese.
- Background: PubMed 12201871Omagari K, Kadokawa Y, Masuda J, Egawa I, Sawa T, Hazama H, Ohba K, Isomoto H, Mizuta Y, Hayashida K, Murase K, Kadota T, Murata I, Kohno S. Fatty liver in non-alcoholic non-overweight Japanese adults: incidence and clinical characteristics. J Gastroenterol Hepatol. 2002 Oct;17(10):1098-105. doi: 10.1046/j.1440-1746.2002.02846.x.
- Background: PubMed 19014878Fan JG, Farrell GC. Epidemiology of non-alcoholic fatty liver disease in China. J Hepatol. 2009 Jan;50(1):204-10. doi: 10.1016/j.jhep.2008.10.010. Epub 2008 Nov 6.
- Background: PubMed 17400323Lee JY, Kim KM, Lee SG, Yu E, Lim YS, Lee HC, Chung YH, Lee YS, Suh DJ. Prevalence and risk factors of non-alcoholic fatty liver disease in potential living liver donors in Korea: a review of 589 consecutive liver biopsies in a single center. J Hepatol. 2007 Aug;47(2):239-44. doi: 10.1016/j.jhep.2007.02.007. Epub 2007 Mar 6.
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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.
Mona A Hegazy, MD principal investigator
Professor of Internal Medicine Hepatology, Faculty of medicine, Cairo University
Ahmed M Abdul Ghani, MD study director
Lecturer of Internal Medicine & Hepatology, Faculty of Medicine, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD and Insulin Resistance, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 5 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 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mona A Hegazy, MD (0201001421551, monahegazy@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of different grads of severity of NAFLD and Correlation with Its main risk Factors among Egyptians (time frame: April 2019 to March 2021). The study lists 3 primary outcomes in all. 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 NCT04081571, which also lists 20 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 10 Mar 2022.