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

• Conditions: NAFLD; Hepatic Steatosis; Insulin Resistance

• Registration Number: NCT04081571
• Lead Sponsor: Cairo University

Brief 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.

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 Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-10
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1080

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dietary history	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
Prevalence of different grads of severity of NAFLD and Correlation with Its main risk Factors among Egyptians	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.
Risk factors of NAFLD	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.

Secondary Outcome Measures

Name	Time	Method
Prevalence of Metabolic syndrome	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	April 2019 to March 2020	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.
Prevalence of Insulin resistance	April 2019 to March 2020	Confirming the high level of insulin resistance in non-diabetic compared to other races
Prevalence of NAFLD among different ethnic groups	April 2019 to March 2020	Trying to confirm the great variability between different races regarding BMI classes and overweight \& obesity cut-off values

Trial Locations

Locations (1)

Faculty of Medicine Cairo University; 🇪🇬 Cairo, Egypt