Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
NAFLD
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 20 years and 80 years
Gender
Both males and females

Description

We aim firstly to assess the serum selenium and zinc level in NAFLD patients, secondly to detect the association between hepatic fibrosis, steatosis, and serum selenium level in NAFLD patients, thirdly to detect if there is a synergistic effect of both molecules. Patients and methods Study design: C...

We aim firstly to assess the serum selenium and zinc level in NAFLD patients, secondly to detect the association between hepatic fibrosis, steatosis, and serum selenium level in NAFLD patients, thirdly to detect if there is a synergistic effect of both molecules. Patients and methods Study design: Case-control study. Studied population & locality: This study will be conducted on two groups: Group (1): include 70 patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Tropical medicine and gastroenterology department, Sohag University Hospitals during the period from March 2021 to August 2021. Group (2): a control group of 30 healthy volunteers who looks normal on ultrasonographic examination. Exclusion criteria: Any patient with a chronic liver disease rather than NAFLD. Methods: All included patients will be subjected to: Detailed history, complete general and systemic examination. BMI will be calculated as follow Abdominal Ultrasonography. Laboratory investigations: Fasting blood sugar Serum lipogram. Liver function tests. CBC. Estimation of serum selenium and zinc level. Liver stiffness measurements to detect the degree of fibrosis and measurement of the degree of steatosis using (Fibroscan). Ethical considerations: The study will be approved by The Ethical committee of medical research, Sohag Faculty of Medicine, Sohag University. After an explanation about the nature of the procedures, possible complications, benefits, and steps of the study, all patients and controls will give written informed consent for participating in the study, performing the abdominal ultrasound, taking blood samples, performing fibroscan. Statistical analysis: Data will be analyzed using STATA version 12.1. Quantitative data were represented as mean, standard deviation, median, and range. Data will be analyzed using a student t-test to compare the means of the two groups. Qualitative data will be presented as numbers and percentages and will be compared using either the Chi-square test or Fisher exact test. P-value will be considered significant if it was less than 0.05.

Tracking Information

NCT #
NCT04834063
Collaborators
Not Provided
Investigators
Study Chair: Radwa Farag, MD Sohag University Study Chair: Yasser Amin, MD Sohag University Study Chair: Haitham Attia, MD Sohag University Study Chair: Ahmed Abdallah, MD Sohag University