Prevalence of NAFLD and Correlation With Its Main Risk Factors Among Egyptian

Insulin Resistance Clinical Trial

Official title:

Prevalence of NAFLD and Correlation With Its Main Risk Factors Among Egyptian Multicenter National Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04081571
• Other study ID #: 1001
• Secondary ID: N-41-2019
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: October 2023

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: Mona A Hegazy, MD
• Phone: 0201001421551
• Email: monahegazy[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1080
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis
• Insulin Resistance
• NAFLD
• Non-alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Cairo University	Cairo

Sponsors (7)

Lead Sponsor	Collaborator
Cairo University	Ain Shams University, Alexandria University, Fayoum University, Mansoura University, National Cancer Institute (NCI), Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (20)

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Fan 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. Review. — View Citation

Guerrero 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. — View Citation

Hegazy 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. — View Citation

Hegazy MA, Samy MA, Tawfik A, Naguib MM, Ezzat A, Behiry ME. Abdominal subcutaneous fat thickness and homeostasis model assessment of insulin resistance as simple predictors of nonalcoholic steatohepatitis. Diabetes Metab Syndr Obes. 2019 Jul 11;12:1105-1111. doi: 10.2147/DMSO.S202343. eCollection 2019. — View Citation

Heron M. Deaths: Leading Causes for 2014. Natl Vital Stat Rep. 2016 Jun;65(5):1-96. — View Citation

Lazo 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. Review. — View Citation

Lee 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. Epub 2007 Mar 6. — View Citation

Loomba 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. Review. — View Citation

Marchesini 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. Review. — View Citation

Omagari 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. — View Citation

Pan 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. Review. — View Citation

Salman A, Hegazy M, AbdElfadl S. Combined Adiponectin Deficiency and Resistance in Obese Patients: Can It Solve Part of the Puzzle in Nonalcoholic Steatohepatitis. Open Access Maced J Med Sci. 2015 Jun 15;3(2):298-302. doi: 10.3889/oamjms.2015.057. Epub 2015 May 30. — View Citation

Schwimmer JB, Deutsch R, Rauch JB, Behling C, Newbury R, Lavine JE. Obesity, insulin resistance, and other clinicopathological correlates of pediatric nonalcoholic fatty liver disease. J Pediatr. 2003 Oct;143(4):500-5. — View Citation

Smith 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. Review. — View Citation

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. Review. — View Citation

White 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. Review. — View Citation

Zhan 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. — View Citation

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	April 2019 to March 2021
Primary	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	April 2019 to March 2021
Primary	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.	April 2019 to March 2021
Secondary	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	April 2019 to March 2020
Secondary	Prevalence of Insulin resistance	Confirming the high level of insulin resistance in non-diabetic compared to other races	April 2019 to March 2020
Secondary	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	April 2019 to March 2020
Secondary	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.	April 2019 to March 2020