Role of New Adipokines and Hepatokines in Prediction of Patients With Metabolic Syndrome or NAFLD

March 14, 2019 updated by: Yonsei University

To investigate the predictive roles of adipokines and hepatokines to detect non-alcoholic fatty liver disease (NAFLD), diabetes, or dyslipidmia.

To examine the association or effects of clinical and biochemical factors (lab results and medication, etc.) on serum levels of adipokines and hepatokines in certain subjects with non-alcoholic fatty liver disease (NAFLD), diabetes, or dyslipidmia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects are recruited from either patients who visit out-patient clinics (Diabetes center in Severance hospital) or healthy volunteers.

Description

Inclusion Criteria:

  1. dyslipidemia 1. serum triglyceride≥150mg/dl, or taking medication to lower triglyceride levels (e.g. fibrates, niacin, omega-3, etc.) or 2. serum LDL-C≥100mg/dl, or taking medication to lower LDL-C levels (e.g. statin, ezetimibe, etc.)
  2. type 2 diabetes 1. defined according to the ADA guideline (DM definition) or 2. taking any anti-diabetic medications
  3. non-alcoholic fatty liver disease (NAFLD) 1. diagnosed as having fatty liver by ultrasonogram or 2. diagnosed as having fatty liver by transient elastogram (Fibroscan) or 3. diagnosed as having fatty liver by abdomina CT scan
  4. Normal control 1. should not be included in other groups as above and 2. not taking any medication related to diabetes and dyslipidemia and 3. BMI <25kg/m2

Exclusion Criteria:

  1. subjects who refused to agree with informed consents
  2. subjects with organ-transplantation
  3. serum creatinine ≥1.5mg/dl
  4. pregnant women
  5. liver cancer or pancreatic cancer
  6. subjects with chronic hepatitis B or C virus infection
  7. for NAFLD group, subjects with excessive alcohol consumption (men: ≥210g of alcohol per week, women: ≥140g of alcohol per week)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1) Normal control
metabolically healthy with no obesity
Other: serum blood sampling
2) dyslipidemia
high triglyceride levels or LDL-C levels
Other: serum blood sampling
3) type 2 diabetes
defined in 'inclusion criteria'
Other: serum blood sampling
4) non-alcoholic fatty liver disease
defined in 'inclusion criteria'
Other: serum blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
new adipokines
Time Frame: To 8h fasting blood sample
several candidate adipokines and hepatokines to predict diseases will be measured using ELISA
To 8h fasting blood sample
new hepatokines
Time Frame: To 8h fasting blood sample
several candidate adipokines and hepatokines to predict diseases will be measured using ELISA
To 8h fasting blood sample

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

November 4, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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