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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04081571

Collaborator

Ain Shams University (Other), Mansoura University (Other), Alexandria University (Other), Fayoum University (Other), Tanta University (Other), National Cancer Institute (NCI) (NIH)

1,080

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NAFLD Insulin Resistance Hepatic Steatosis

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

Study Type:

Observational

Anticipated Enrollment :

1080 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Outcome Measures

Primary Outcome Measures

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.
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 : 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 [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

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
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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Cairo University	Cairo		Egypt

Sponsors and Collaborators

Cairo University
Ain Shams University
Mansoura University
Alexandria University
Fayoum University
Tanta University
National Cancer Institute (NCI)

Investigators

Principal Investigator: Mona A Hegazy, MD, Professor of Internal Medicine Hepatology, Faculty of medicine, Cairo University
Study Director: Ahmed M Abdul Ghani, MD, Lecturer of Internal Medicine & Hepatology, Faculty of Medicine, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Mona Hegazy, Professor of Internal Medicine Hepatology & gastroenterology Unit Faculty of medicine, Cairo University, Cairo University

ClinicalTrials.gov Identifier:

NCT04081571

Other Study ID Numbers:

1001
N-41-2019

First Posted:

Sep 9, 2019

Last Update Posted:

Mar 10, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mona Hegazy, Professor of Internal Medicine Hepatology & gastroenterology Unit Faculty of medicine, Cairo University, Cairo University

Additional relevant MeSH terms:

Non-alcoholic Fatty Liver Disease

Fatty Liver

Insulin Resistance

Study Results

No Results Posted as of Mar 10, 2022