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

• Conditions: Metabolic Syndrome; Non-alcoholic Fatty Liver Disease; Type 2 Diabetes
• Interventions: Other: serum blood sampling

• Registration Number: NCT02285218
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-06
• Status Verified: 2019-03
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
new adipokines	To 8h fasting blood sample	several candidate adipokines and hepatokines to predict diseases will be measured using ELISA
new hepatokines	To 8h fasting blood sample	several candidate adipokines and hepatokines to predict diseases will be measured using ELISA

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of