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

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ClinicalTrials.gov Identifier: NCT02285218
Recruitment Status : Unknown
Verified November 2014 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : November 6, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Non-alcoholic Fatty Liver Disease Type 2 Diabetes Metabolic Syndrome Other: serum blood sampling

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : April 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015


Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. new adipokines [ Time Frame: To 8h fasting blood sample ]
    several candidate adipokines and hepatokines to predict diseases will be measured using ELISA

  2. new hepatokines [ Time Frame: To 8h fasting blood sample ]
    several candidate adipokines and hepatokines to predict diseases will be measured using ELISA


Biospecimen Retention:   Samples Without DNA
plasma (blood)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285218


Contacts
Contact: Bong Soo Cha, MD +82-2-2228-1932 bscha@yuhs.ac

Locations
Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Bong Soo Cha, MD    +82-2-2228-1932    bscha@yuhs.ac   
Sponsors and Collaborators
Yonsei University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02285218     History of Changes
Other Study ID Numbers: 4-2014-0073
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases