Prevalence of NAFLD and Correlation With Its Main Risk Factors Among Egyptian
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|ClinicalTrials.gov Identifier: NCT04081571|
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
|Condition or disease|
|NAFLD Insulin Resistance Hepatic Steatosis|
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 (Triglycerides)), fasting blood glucose and insulin (HOMA-IR (insulin resistance) will be calculated), HbA1c%, liver biochemistry tests (ALT, GGT (Gamma-glutamyl transferase), 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 Type :||Observational|
|Estimated Enrollment :||1080 participants|
|Official Title:||Prevalence of NAFLD and Correlation With Its Main Risk Factors Among Egyptian Multicenter National Study|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
- 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 :
- 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
- 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.
- Prevalence of NAFLD among different ethnic groups [ Time Frame: April 2019 to March 2020 ]Trying to confirm the great variability between different races regarding BMI classes and overweight & obesity cut-off values
- Prevalence of Insulin resistance [ Time Frame: April 2019 to March 2020 ]Confirming the high level of insulin resistance in non-diabetic compared to other races
- Prevalence of Metabolic syndrome [ Time Frame: April 2019 to March 2020 ]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
- NASH staging [ Time Frame: April 2019 to March 2020 ]Trying to get a cut-off value for LSFT and USFT (subcutaneous fat in front of the left lobe of the liver and at umbilical region) as the investigators previous published work concluded that: LSFR, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04081571
|Contact: Mona A Hegazy, MD||0201001421551||MONAHEGAZY@HOTMAIL.COM|
|Contact: Ahmed M Abdul Ghani, MD||0201005150375||Abdelgany@staff.cu.edu.eg|
|Faculty of Medicine Cairo University||Recruiting|
|Contact: Mona A Hegazy, MD 0201001421551 MONAHEGAZY@HOTMAIL.COM|
|Contact: Ahmed M Abdul Ghani, MD 0201005150375 Abdelgany@staff.cu.edu.eg|
|Principal Investigator:||Mona A Hegazy, MD||Professor of Internal Medicine Hepatology, Faculty of medicine, Cairo University|