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

NCT ID: NCT04081571

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1080 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2023-10-31

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.

Conditions

NAFLD; Insulin Resistance; Hepatic Steatosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: collaborator

Mansoura University

OTHER

Sponsor Role: collaborator

Alexandria University

OTHER

Sponsor Role: collaborator

Fayoum University

OTHER

Sponsor Role: collaborator

Tanta University

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mona Hegazy

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mona A Hegazy, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Internal Medicine Hepatology, Faculty of medicine, Cairo University

Ahmed M Abdul Ghani, MD

Role: STUDY_DIRECTOR

Lecturer of Internal Medicine & Hepatology, Faculty of Medicine, Cairo University

Locations

Faculty of Medicine Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mona A Hegazy, MD

Role: CONTACT

monahegazy@cu.edu.eg

0201001421551

Ahmed M Abdul Ghani, MD

Role: CONTACT

Abdelgany@staff.cu.edu.eg

0201005150375

Facility Contacts

Mona A Hegazy, MD

Role: primary

monahegazy@cu.edu.eg

0201001421551

Ahmed M Abdul Ghani, MD

Role: backup

Abdelgany@staff.cu.edu.eg

0201005150375

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Other Identifiers

N-41-2019

Identifier Type: OTHER

Identifier Source: secondary_id

1001

Identifier Type: -

Identifier Source: org_study_id