Serum Selenium and Zinc Levels in Non-alcoholic Fatty Liver Disease Patients

NCT04834063 | Completed

• 1 other identifier: Soh-Med-21-03-12
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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 advanced/decompensated disease.

Conditions

NAFLD

Keywords

NAFLD; Fibrosis; selenium; zinc

Outcome Measures

Primary Outcomes (4)

• serum selenium level in NAFLD patients

  during the period from March 2021 to August 2021

• the association between hepatic fibrosis and serum selenium level in NAFLD patients

  during the period from March 2021 to August 2021

• serum zinc level in NAFLD patients

  during the period from March 2021 to August 2021

• the association between hepatic fibrosis and serum zinc level in NAFLD patients

  during the period from March 2021 to August 2021

Study Arms (2)

NAFLD Cases

Non- alcoholic fatty liver disease

Diagnostic Test: Serum Zinc a level; Diagnostic Test: serum selenium level; Diagnostic Test: Fibroscan measurement

control

healthy individual with normal liver on abdominal ultrasound

Diagnostic Test: Serum Zinc a level; Diagnostic Test: serum selenium level; Diagnostic Test: Fibroscan measurement

Interventions

Serum Zinc a level DIAGNOSTIC_TEST

Diagnostic test

NAFLD Cases; control

serum selenium level DIAGNOSTIC_TEST

Diagnostic test

NAFLD Cases; control

Fibroscan measurement DIAGNOSTIC_TEST

Diagnostic test

NAFLD Cases; control

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

group (1): patients diagnosed to have 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

You may qualify if:

• patients diagnosed to have 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.

You may not qualify if:

• Any patient with a chronic liver disease rather than NAFLD

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Mona Mohammed Abdelrahman

Sohag, Egypt

Location

Related Publications (5)

• Kosari F, Jamali R, Ramim T, Mosavi Jahan Abad E. The Correlation between Serum Zinc Level and Liver Histology in Non-Alcoholic Steatohepatitis. Iran J Pathol. 2019 Winter;14(1):17-25. doi: 10.30699/IJP.14.1.17. Epub 2018 Dec 27.

  PMID: 31531097 BACKGROUND

• Reja M, Makar M, Visaria A, Marino D, Rustgi V. Increased serum selenium levels are associated with reduced risk of advanced liver fibrosis and all-cause mortality in NAFLD patients: National Health and Nutrition Examination Survey (NHANES) III. Ann Hepatol. 2020 Nov-Dec;19(6):635-640. doi: 10.1016/j.aohep.2020.07.006. Epub 2020 Jul 31.

  PMID: 32745632 BACKGROUND

• Aigner E, Strasser M, Haufe H, Sonnweber T, Hohla F, Stadlmayr A, Solioz M, Tilg H, Patsch W, Weiss G, Stickel F, Datz C. A role for low hepatic copper concentrations in nonalcoholic Fatty liver disease. Am J Gastroenterol. 2010 Sep;105(9):1978-85. doi: 10.1038/ajg.2010.170. Epub 2010 Apr 20.

  PMID: 20407430 BACKGROUND

• Pickett-Blakely O, Young K, Carr RM. Micronutrients in Nonalcoholic Fatty Liver Disease Pathogenesis. Cell Mol Gastroenterol Hepatol. 2018 Aug 23;6(4):451-462. doi: 10.1016/j.jcmgh.2018.07.004. eCollection 2018.

  PMID: 30294653 BACKGROUND

• Mohammad MK, Zhou Z, Cave M, Barve A, McClain CJ. Zinc and liver disease. Nutr Clin Pract. 2012 Feb;27(1):8-20. doi: 10.1177/0884533611433534.

  PMID: 22307488 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fibrosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 6, 2021
• Study Start: March 15, 2021
• Primary Completion: September 5, 2021
• Study Completion: September 25, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)