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

NCT ID: NCT02285218

Last Updated: 2019-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2019-03-31

Brief Summary

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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

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Conditions

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Non-alcoholic Fatty Liver Disease Type 2 Diabetes Metabolic Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1) Normal control

metabolically healthy with no obesity

serum blood sampling

Intervention Type OTHER

2) dyslipidemia

high triglyceride levels or LDL-C levels

serum blood sampling

Intervention Type OTHER

3) type 2 diabetes

defined in 'inclusion criteria'

serum blood sampling

Intervention Type OTHER

4) non-alcoholic fatty liver disease

defined in 'inclusion criteria'

serum blood sampling

Intervention Type OTHER

Interventions

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serum blood sampling

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Bong Soo Cha, MD

Role: CONTACT

+82-2-2228-1932

Facility Contacts

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Bong Soo Cha, MD

Role: primary

+82-2-2228-1932

References

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Lee YH, Lee SG, Lee CJ, Kim SH, Song YM, Yoon MR, Jeon BH, Lee JH, Lee BW, Kang ES, Lee HC, Cha BS. Association between betatrophin/ANGPTL8 and non-alcoholic fatty liver disease: animal and human studies. Sci Rep. 2016 Apr 5;6:24013. doi: 10.1038/srep24013.

Reference Type DERIVED
PMID: 27045862 (View on PubMed)

Other Identifiers

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4-2014-0073

Identifier Type: -

Identifier Source: org_study_id

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