Clinical trial NCT01257685: Selenoprotein P and Non-alcoholic Fatty Liver Disease
Official title: Selenoprotein P and Non-alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-alcoholic Fatty Liver Disease
Insulin Resistance
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2010-12-10
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers for visiting routine medical check in our clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Association between SeP and NAFLD
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Compare SeP level between control and NAFLD group
timeFrame: through study completion, an average of 2 year
measure: Correlation between SeP level and cardiometabolic risk factors
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hae Yoon Choi
Study officials:
affiliation: Korea University
name: Kyung Mook Choi, MD.PhD
role: STUDY_DIRECTOR
References: