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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
Sponsor:
Collaborators:
Ain Shams University
Mansoura University
Alexandria University
Fayoum University
Tanta University
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mona Hegazy, 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.

Condition or disease
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 (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.


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Study Type : Observational
Estimated 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 : April 1, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021





Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Mona A Hegazy, MD 0201001421551 MONAHEGAZY@HOTMAIL.COM
Contact: Ahmed M Abdul Ghani, MD 0201005150375 Abdelgany@staff.cu.edu.eg

Locations
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Egypt
Faculty of Medicine Cairo University Recruiting
Cairo, Egypt
Contact: Mona A Hegazy, MD    0201001421551    MONAHEGAZY@HOTMAIL.COM   
Contact: Ahmed M Abdul Ghani, MD    0201005150375    Abdelgany@staff.cu.edu.eg   
Sponsors and Collaborators
Cairo University
Ain Shams University
Mansoura University
Alexandria University
Fayoum University
Tanta University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mona A Hegazy, MD Professor of Internal Medicine Hepatology, Faculty of medicine, Cairo University

Publications:

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Responsible Party: Mona Hegazy, Professor of Internal Medicine Hepatology & gastroenterology Unit Faculty of medicine, Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT04081571     History of Changes
Other Study ID Numbers: 1001
N-41-2019 ( Other Identifier: Cairo University ethical committee approval number )
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mona Hegazy, Cairo University:
NAFLD
Insulin Resistance
Hepatic Steatosis
EGYPTIAN
Additional relevant MeSH terms:
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Non-alcoholic Fatty Liver Disease
Fatty Liver
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases