Selenoprotein P and Non-alcoholic Fatty Liver Disease

Completed

• Conditions: Non-alcoholic Fatty Liver Disease; Insulin Resistance

• Registration Number: NCT01257685
• Lead Sponsor: Korea University

Brief Summary

The pathogenesis of nonalcoholic fatty liver disease has not been fully elucidated. The most widely supported theory implicates insulin resistance as the key mechanism leading to hepatic steatosis, and perhaps also to steatohepatitis.

Selenoprotein P(SeP) is a secretory protein primarily produced by the liver. Previous studies demonstrated that SeP, a liver-derived secretory protein, causes insulin resistance.

Therefore, the purpose of this study is to determine the different Sep levels between healthy normal group and NAFLD group.

Detailed Description

Nonalcoholic fatty liver disease (NAFLD), a disease spectrum that includes simple steatosis, nonalcoholic steatohepatitis (NASH) and cirrhosis, has been increasingly recognized as the hepatic manifestation of metabolic syndrome. Both inflammation and insulin resistance are considered to be pivotal pathogenic mechanisms of NAFLD, as well as metabolic syndrome, type 2 diabetes, and atherosclerosis. There is mounting evidence implicating adipokines secreted from adipose tissue in the pathogenesis and progression of NAFLD, in addition to the development of insulin resistance and inflammation. Selenoprotein P (SeP) has recently been reported as a novel hepatokine that regulates insulin resistance and systemic energy metabolism in rodents and humans. Although previous studies have shown a close relationship among insulin resistance, inflammation, and NAFLD, as far as we know, there is no previous report evaluating the association between SeP and NAFLD. In the present study, we examined serum SeP levels in subjects with increased visceral fat area (VFA) or liver fat accumulation measured with computed tomography (CT). We evaluated the relationship between SeP levels and cardiometabolic risk factors.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-09
• Study First Posted: 2010-12-10
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Healthy volunteers for visiting routine medical check in our clinic

Exclusion Criteria

• History of cardiovascular disease(myocardial infarction, unstable angina, or cardiovascular revascularization)
• Diabetes
• Hypertension
• Malignancy
• Severe renal or hepatic disease
• Subjects taking medications that might affect body weight or body composition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association between SeP and NAFLD	through study completion, an average of 2 year	We used multiple logistic regression analysis

Secondary Outcome Measures

Name	Time	Method
Compare SeP level between control and NAFLD group	through study completion, an average of 2 year	using Mann-Whitney U test
Correlation between SeP level and cardiometabolic risk factors	through study completion, an average of 2 year	SeP level was stratified by tertile.

Trial Locations

Locations (1)

Hae Yoon Choi; 🇰🇷 Seoul, Korea, Republic of