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

March 9, 2022 updated by: Mona Hegazy, Cairo University

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1080

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
April 2019 to March 2021
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
April 2019 to March 2021
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.
April 2019 to March 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
April 2019 to March 2020
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
April 2019 to March 2020
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
April 2019 to March 2020
NASH staging
Time Frame: 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.
April 2019 to March 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

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

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

July 30, 2019

First Submitted That Met QC Criteria

September 4, 2019

First Posted (Actual)

September 9, 2019

Study Record Updates

Last Update Posted (Actual)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1001 (Registro Nacional Estudios Clinicos (RNEC))
  • N-41-2019 (Other Identifier: Cairo University ethical committee approval number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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