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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02285218
• Other study ID #: 4-2014-0073
• Status: Recruiting
• Start date: April 2014
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: Bong Soo Cha, MD
• Phone: +82-2-2228-1932
• Email: bscha[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Metabolic Syndrome
• Non-alcoholic Fatty Liver Disease
• Syndrome
• Type 2 Diabetes

Intervention

Other:
• serum blood sampling

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	new adipokines	several candidate adipokines and hepatokines to predict diseases will be measured using ELISA	To 8h fasting blood sample
Primary	new hepatokines	several candidate adipokines and hepatokines to predict diseases will be measured using ELISA	To 8h fasting blood sample