NCT02083159

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) is characterized by an accumulation of fat in the liver, which is one of the most common forms of chronic liver disease in developed countries. In western countries, the prevalence of NAFLD in the general population is estimated to be 20-30%; in obese populations, this increases to 57.5-74%. But, it hasn't been clearly elucidated yet regarding the underlying disease pathophysiology and treatmet strategy. Recently, members of the C1q/tumor necrosis factor-related protein (CTRP) family have been reported to share structural homology with adiponectin. To date, 15 CTRP family members have been found that might play major roles in glucose metabolism and inflammation. The investigators tried to clarify the relationship between CTRP family and NAFLD in Korean men and women.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

4.8 years

First QC Date

March 7, 2014

Last Update Submit

September 19, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • serum concentration of CTRP-1, 3, or 9 in the subjects with/without NAFLD

    at enrollment

Secondary Outcomes (1)

  • The relationships of serum CTRPs/adiponectin levels with cardiometabolic risk profiles

    at enrollment

Study Arms (1)

Patients with NAFLD

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The subjects who visited for a routine health check-up at the Health Promotion Center of Korea University Guro Hospital were enrolled using predefined inclusion and exclusion criteria.

You may qualify if:

  • \<age\<80
  • apparently healthy subjects

You may not qualify if:

  • a history of CVD
  • diabetes
  • stage 2 hypertension
  • malignancy
  • severe renal or hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea Univ. Guro Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Central Study Contacts

Ho Cheol Hong, M.D.

CONTACT

Kyung Mook Choi, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 11, 2014

Study Start

March 1, 2012

Primary Completion

December 1, 2016

Last Updated

September 21, 2016

Record last verified: 2016-09

Locations