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Selenoprotein P and Non-alcoholic Fatty Liver Disease

This study has been completed.
Sponsor:
Information provided by:
Korea University
ClinicalTrials.gov Identifier:
NCT01257685
First received: December 9, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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.


Condition
Non-Alcoholic Fatty Liver Disease
Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Selenoprotein P and Non-alcoholic Fatty Liver Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Korea University:

Primary Outcome Measures:
  • Selenoprotein P [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DXA-measured trunk fat mass [ Designated as safety issue: No ]
  • CT-measured visceral fat area [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: September 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control Group
NAFLD Group

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy volunteers for visiting routine medical check in our clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257685

Locations
Korea, Republic of
Hae Yoon Choi
Seoul, Korea, Republic of, 152-703
Sponsors and Collaborators
Korea University
Investigators
Study Director: Kyung Mook Choi, MD.PhD Korea University
  More Information

No publications provided

Responsible Party: Kyung Mook Choi, Korea university
ClinicalTrials.gov Identifier: NCT01257685     History of Changes
Other Study ID Numbers: SEPP1(NAFLD)
Study First Received: December 9, 2010
Last Updated: December 9, 2010
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Fatty Liver
Insulin Resistance
Liver Diseases
Digestive System Diseases
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 13, 2013