跳至主要内容
临床试验/NCT04081571
NCT04081571Unknown不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 1,080 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,080
试验地点
1
主要终点
Dietary history

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

结局指标

主要结局

Dietary history

时间窗: 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

Prevalence of different grads of severity of NAFLD and Correlation with Its main risk Factors among Egyptians

时间窗: 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.

Risk factors of NAFLD

时间窗: 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.

次要结局

  • Prevalence of Metabolic syndrome(April 2019 to March 2020)
  • NASH staging(April 2019 to March 2020)
  • Prevalence of Insulin resistance(April 2019 to March 2020)
  • Prevalence of NAFLD among different ethnic groups(April 2019 to March 2020)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mona Hegazy

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

Cairo University

研究点 (1)

Loading locations...

相似试验