Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04834063
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2021-03-30
Brief Title:
Serum Selenium and Zinc Levels in Non-alcoholic Fatty Liver Disease Patients
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Evaluation of Serum Selenium and Zinc Levels in Non-alcoholic Fatty Liver Disease Patients
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAFLD
Brief Summary:
Non-alcoholic fatty liver disease NAFLD includes a wide range of disorders that consist of simple fatty infiltration steatohepatitis NASH and end-stage liver disease cirrhosis NAFLD is the most common cause of chronic liver disease worldwide and increases the risk of end-stage liver disease and hepatocellular carcinoma HCC While risk factors such as obesity diabetes and a sedentary lifestyle may increase the risk of NAFLD studies have shown that environmental exposures may further contribute to the pathogenesis of NAFLD Although the pathogenic role of macronutrients is well established in both NAFLD and obesity the contribution of micronutrients to NAFLD pathogenesis has garnered less attention than with obesity
Selenium is an essential element in many biological functions and is an important component of human nutrition Exposure to selenium can be found in nature such as rocks and sediment air soil fuel oil drinking water and nutritional supplementation It is a major component of many enzymes such as glutathione peroxidase and plays an important role in anti-oxidation DNA synthesis reproduction muscle function and thyroid metabolism Selenium concentrations have been studied in many diseases and organ systems including the liver However the exact relationship between selenium in patients with NAFLD is unclear
Selenium is an essential element in many biological functions and is an important component of human nutrition It is a major component of many enzymes such as glutathione peroxidase and plays an important role in anti-oxidation DNA synthesis reproduction muscle function and thyroid metabolism Selenium concentrations have been studied in many diseases and organ systems including the liver However the exact relationship between selenium in patients with NAFLD is unclear
Despite data suggesting mineral deficiencies in NAFLD patients most data do not support insufficient mineral consumption as a possible mechanism for these deficiencies except in the case of zinc deficiency Zinc is the second most prevalent trace element in the body It is integrally involved in the normal life cycle and has many important regulatory catalytic and defensive functions Zinc deficiency occurs in many types of liver disease especially more advanceddecompensated disease
Selenium is an essential element in many biological functions and is an important component of human nutrition Exposure to selenium can be found in nature such as rocks and sediment air soil fuel oil drinking water and nutritional supplementation It is a major component of many enzymes such as glutathione peroxidase and plays an important role in anti-oxidation DNA synthesis reproduction muscle function and thyroid metabolism Selenium concentrations have been studied in many diseases and organ systems including the liver However the exact relationship between selenium in patients with NAFLD is unclear
Selenium is an essential element in many biological functions and is an important component of human nutrition It is a major component of many enzymes such as glutathione peroxidase and plays an important role in anti-oxidation DNA synthesis reproduction muscle function and thyroid metabolism Selenium concentrations have been studied in many diseases and organ systems including the liver However the exact relationship between selenium in patients with NAFLD is unclear
Despite data suggesting mineral deficiencies in NAFLD patients most data do not support insufficient mineral consumption as a possible mechanism for these deficiencies except in the case of zinc deficiency Zinc is the second most prevalent trace element in the body It is integrally involved in the normal life cycle and has many important regulatory catalytic and defensive functions Zinc deficiency occurs in many types of liver disease especially more advanceddecompensated disease
Detailed 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
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
1 Detailed history complete general and systemic examination
2 BMI will be calculated as follow
3 Abdominal Ultrasonography
4 Laboratory investigations
Fasting blood sugar
Serum lipogram
Liver function tests
CBC
5 Estimation of serum selenium and zinc level
6 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 121 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 005
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
1 Detailed history complete general and systemic examination
2 BMI will be calculated as follow
3 Abdominal Ultrasonography
4 Laboratory investigations
Fasting blood sugar
Serum lipogram
Liver function tests
CBC
5 Estimation of serum selenium and zinc level
6 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 121 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None