Selenoprotein P and Non-alcoholic Fatty Liver Disease

NCT01257685 | Completed DMC

• 1 other identifier: SEPP1(NAFLD)
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Association between SeP and NAFLD

  We used multiple logistic regression analysis

  through study completion, an average of 2 year

Secondary Outcomes (2)

• Compare SeP level between control and NAFLD group

  through study completion, an average of 2 year

• Correlation between SeP level and cardiometabolic risk factors

  through study completion, an average of 2 year

Study Arms (2)

Control Group

Normal group

NAFLD Group

NAFLD in the present study was defined a value of LAI \<5 HU using an unenhaned CT.

Eligibility Criteria

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

Study Population

Healthy volunteers for visiting routine medical check in our clinic

You may qualify if:

• Healthy volunteers for visiting routine medical check in our clinic

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University: lead

Study Sites (1)

Hae Yoon Choi

Seoul, 152-703, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples. Abdominal VFA and total abdominal fat area were measured via CT scan without an intravenous contrast agent

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Insulin Resistance

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kyung Mook Choi, MD.PhD

  Korea University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: September 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: September 3, 2020

Record last verified: 2020-08

Locations

KR (1)