- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02285218
Role of New Adipokines and Hepatokines in Prediction of Patients With Metabolic Syndrome or NAFLD
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
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Recruiting
- Severance Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.)
- type 2 diabetes 1. defined according to the ADA guideline (DM definition) or 2. taking any anti-diabetic medications
- 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
- 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:
- subjects who refused to agree with informed consents
- subjects with organ-transplantation
- serum creatinine ≥1.5mg/dl
- pregnant women
- liver cancer or pancreatic cancer
- subjects with chronic hepatitis B or C virus infection
- for NAFLD group, subjects with excessive alcohol consumption (men: ≥210g of alcohol per week, women: ≥140g of alcohol per week)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1) Normal control
metabolically healthy with no obesity
|
|
2) dyslipidemia
high triglyceride levels or LDL-C levels
|
|
3) type 2 diabetes
defined in 'inclusion criteria'
|
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4) non-alcoholic fatty liver disease
defined in 'inclusion criteria'
|
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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