Non-alcoholic Fatty Liver DiseaseNCT02285218
Role of New Adipokines and Hepatokines in Prediction of Patients With Metabolic Syndrome or NAFLD
An observational study of Non-alcoholic Fatty Liver Disease and Type 2 Diabetes, run by Yonsei University at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Type 2 Diabetes, Metabolic Syndrome
- What is being tested?
- serum blood sampling
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects are recruited from either patients who visit out-patient clinics (Diabetes center in Severance hospital) or healthy volunteers.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance hospital
Seoul, 120-752
Bong Soo Cha, MD, +82-2-2228-1932, bscha@yuhs.ac
About this study
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.
- Being tested
- serum blood sampling
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum blood samplingOther
| Study group | Role | What they receive |
|---|---|---|
| 1) Normal control | metabolically healthy with no obesity Receives: Other: serum blood sampling | |
| 2) dyslipidemia | high triglyceride levels or LDL-C levels Receives: Other: serum blood sampling | |
| 3) type 2 diabetes | defined in 'inclusion criteria' Receives: Other: serum blood sampling | |
| 4) non-alcoholic fatty liver disease | defined in 'inclusion criteria' Receives: Other: serum blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
new adipokines
several candidate adipokines and hepatokines to predict diseases will be measured using ELISA
Measured: To 8h fasting blood sample
new hepatokines
several candidate adipokines and hepatokines to predict diseases will be measured using ELISA
Measured: To 8h fasting blood sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285218
- Sponsor's protocol ID
- 4-2014-0073
- Status last verified
- Mar 2019
- First submitted
- 4 Nov 2014
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27045862
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of New Adipokines and Hepatokines in Prediction of Patients With Metabolic Syndrome or NAFLD
- ClinicalTrials.gov ID
- NCT02285218
- Acronym / sponsor ID
- 4-2014-0073
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1) Normal control | – | Other: serum blood samplingmetabolically healthy with no obesity |
| 2) dyslipidemia | – | Other: serum blood samplinghigh triglyceride levels or LDL-C levels |
| 3) type 2 diabetes | – | Other: serum blood samplingdefined in 'inclusion criteria' |
| 4) non-alcoholic fatty liver disease | – | Other: serum blood samplingdefined in 'inclusion criteria' |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are recruited from either patients who visit out-patient clinics (Diabetes center in Severance hospital) or healthy volunteers.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- subjects who refused to agree with informed consents
- subjects with organ-transplantation
- serum creatinine ≥1.5mg/dl
- pregnant women
- liver cancer or pancreatic cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum blood sampling | Other | 1) Normal control, 2) dyslipidemia, 3) type 2 diabetes, 4) non-alcoholic fatty liver disease |
Primary outcome
new adipokines
Time frame: To 8h fasting blood sample
several candidate adipokines and hepatokines to predict diseases will be measured using ELISA
new hepatokines
Time frame: To 8h fasting blood sample
several candidate adipokines and hepatokines to predict diseases will be measured using ELISA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Derived from this study: PubMed 27045862Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease and Type 2 Diabetes, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bong Soo Cha, MD (+82-2-2228-1932, bscha@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
new adipokines (time frame: To 8h fasting blood sample). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02285218, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.