Clinical trial NCT04081571: Prevalence of NAFLD and Correlation With Its Main Risk Factors Among Egyptian
Official title: Prevalence of NAFLD and Correlation With Its Main Risk Factors Among Egyptian Multicenter National Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NAFLD
Insulin Resistance
Hepatic Steatosis
Keywords: NAFLD
Insulin Resistance
Hepatic Steatosis
EGYPTIAN
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
name: Mansoura University
name: Alexandria University
name: Fayoum University
name: Tanta University
name: National Cancer Institute (NCI)
First posted: 2019-09-09
Enrollment: 1080
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Prevalence of different grads of severity of NAFLD and Correlation with Its main risk Factors among Egyptians
timeFrame: April 2019 to March 2021
measure: Dietary history
timeFrame: April 2019 to March 2021
measure: Risk factors of NAFLD
timeFrame: April 2019 to March 2021
Secondary outcomes:
measure: Prevalence of NAFLD among different ethnic groups
timeFrame: April 2019 to March 2020
measure: Prevalence of Insulin resistance
timeFrame: April 2019 to March 2020
measure: Prevalence of Metabolic syndrome
timeFrame: April 2019 to March 2020
measure: NASH staging
timeFrame: April 2019 to March 2020
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Cairo University
Study officials:
affiliation: Professor of Internal Medicine Hepatology, Faculty of medicine, Cairo University
name: Mona A Hegazy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Internal Medicine & Hepatology, Faculty of Medicine, Cairo University
name: Ahmed M Abdul Ghani, MD
role: STUDY_DIRECTOR
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