NAFLDNCT02083159
C1q/TNF-related Proteins in Non-Alcoholic Fatty Liver Disease
An observational study of NAFLD, run by Korea University at 1 site in South Korea.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) is characterized by an accumulation of fat in the liver, which is one of the most common forms of chronic liver disease in developed countries. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subjects who visited for a routine health check-up at the Health Promotion Center of Korea University Guro Hospital were enrolled using predefined inclusion and exclusion criteria.
Who may be able to join
- 20<age<80
- apparently healthy subjects
Who cannot join
- a history of CVD
- diabetes
- stage 2 hypertension
- malignancy
- severe renal or hepatic disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea Univ. Guro Hospital
Seoul
Ho Cheol Hong, M.D., 822-2626-3044, naeyo21@naver.com
Kyung Mook Choi, M.D., 822-2626-3043, medica7@gmail.com
About this study
Non-alcoholic fatty liver disease (NAFLD) is characterized by an accumulation of fat in the liver, which is one of the most common forms of chronic liver disease in developed countries. In western countries, the prevalence of NAFLD in the general population is estimated to be 20-30%; in obese populations, this increases to 57.5-74%. But, it hasn't been clearly elucidated yet regarding the underlying disease pathophysiology and treatmet strategy.
Recently, members of the C1q/tumor necrosis factor-related protein (CTRP) family have been reported to share structural homology with adiponectin. To date, 15 CTRP family members have been found that might play major roles in glucose metabolism and inflammation.
The investigators tried to clarify the relationship between CTRP family and NAFLD in Korean men and women.
- Conditions
- NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with NAFLD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum concentration of CTRP-1, 3, or 9 in the subjects with/without NAFLD
Measured: at enrollment
Secondary outcomes (1)
The relationships of serum CTRPs/adiponectin levels with cardiometabolic risk profiles
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2012
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung Mook Choi, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083159
- Sponsor's protocol ID
- NAFLD(CTRP)
- Status last verified
- Sep 2016
- First submitted
- 7 Mar 2014
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C1q/TNF-related Proteins in Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT02083159
- Acronym / sponsor ID
- NAFLD(CTRP)
- Conditions
- NAFLD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2016 (estimated)
- First posted
- 11 Mar 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.
Non-alcoholic fatty liver disease (NAFLD) is characterized by an accumulation of fat in the liver, which is one of the most common forms of chronic liver disease in developed countries. In western countries, the prevalence of NAFLD in the general population is estimated to be 20-30%; in obese populations, this increases to 57.5-74%. But, it hasn't been clearly elucidated yet regarding the underlying disease pathophysiology and treatmet strategy.
Recently, members of the C1q/tumor necrosis factor-related protein (CTRP) family have been reported to share structural homology with adiponectin. To date, 15 CTRP family members have been found that might play major roles in glucose metabolism and inflammation.
The investigators tried to clarify the relationship between CTRP family and NAFLD in Korean men and women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with NAFLD | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects who visited for a routine health check-up at the Health Promotion Center of Korea University Guro Hospital were enrolled using predefined inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- 20<age<80
- apparently healthy subjects
Key exclusion criteria (5 listed)
- a history of CVD
- diabetes
- stage 2 hypertension
- malignancy
- severe renal or hepatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serum concentration of CTRP-1, 3, or 9 in the subjects with/without NAFLD
Time frame: at enrollment
1 secondary outcome
The relationships of serum CTRPs/adiponectin levels with cardiometabolic risk profiles
Time frame: at enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
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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 NAFLD, run by Korea 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 2 inclusion and 5 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 21 Sep 2016. 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 Ho Cheol Hong, M.D. (822-2626-3044, naeyo21@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum concentration of CTRP-1, 3, or 9 in the subjects with/without NAFLD (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2016.