AtherosclerosisNCT01979068
Vascular Inflammation Stratified by Body Size Phenotype
An observational study of Atherosclerosis and Obesity, run by Korea University at 1 site in South Korea.
Trial summary
Vascular Inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18FDG-PET is a promising novel tool for identifying and quantifying vascular inflammation within atherosclerotic plaque Recently, unique subsets of obese individuals, such as metabolically obese but normal weight (MONW) and… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Obesity, Metabolic Syndrome
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2008to Mar 2011
- 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: Healthy volunteers who underwent a medical health check in the health promotion center in Korea University Guro Hospital
Who may be able to join
- Healthy patients for visiting routine medical check in our clinic
Who cannot join
- history of CVD (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
- stage 2 hypertension (resting blood pressure, ≥160/100 mmHg)
- history of inflammatory conditions that affect the study results
- taking medications that might affect inflammatory status, including steroid and non-steroidal anti-inflammatory drug within 6 months
- or malignancy or severe renal or hepatic disease
Trial locations and contacts
1 site in 1 country.
About this study
- Vascular Inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18FDG-PET is a promising novel tool for identifying and quantifying vascular inflammation within atherosclerotic plaque
- Recently, unique subsets of obese individuals, such as metabolically obese but normal weight (MONW) and metabolically healthy obese (MHO), have been getting an attention
- Therefore, the purpose of this study is to examine the relationship of vascular inflammation,measured by FDG-PET, with various body sized phenotypes
- Conditions
- Atherosclerosis, Obesity, Metabolic Syndrome
- Medical subject headings
- Atherosclerosis, Obesity, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
max TBR values stratified by the four body size phenotypes
Measured: 12 weeks
Secondary outcomes (1)
Framingham risk scores according to the four body size phenotypes
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startMar 2008
- Primary completionMar 2011
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 AtherosclerosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K. M. Choi, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979068
- Sponsor's protocol ID
- PET_MONW
- Status last verified
- Nov 2013
- First submitted
- 28 Oct 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoo HJ, Kim S, Hwang SY, Hong HC, Choi HY, Seo JA, Kim SG, Kim NH, Choi DS, Baik SH, Choi KM. Vascular inflammation in metabolically abnormal but normal-weight and metabolically healthy obese individuals analyzed with (1)(8)F-fluorodeoxyglucose positron emission tomography. Am J Cardiol. 2015 Feb 15;115(4):523-8. doi: 10.1016/j.amjcard.2014.11.036. Epub 2014 Nov 29.
PubMed 25529544
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Inflammation Stratified by Body Size Phenotype
- ClinicalTrials.gov ID
- NCT01979068
- Acronym / sponsor ID
- PET_MONW
- Conditions
- Atherosclerosis, Obesity, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2011 (actual)
- First posted
- 8 Nov 2013 (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.
- Vascular Inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18FDG-PET is a promising novel tool for identifying and quantifying vascular inflammation within atherosclerotic plaque
- Recently, unique subsets of obese individuals, such as metabolically obese but normal weight (MONW) and metabolically healthy obese (MHO), have been getting an attention
- Therefore, the purpose of this study is to examine the relationship of vascular inflammation,measured by FDG-PET, with various body sized phenotypes
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers who underwent a medical health check in the health promotion center in Korea University Guro Hospital
Key inclusion criteria (1 listed)
- Healthy patients for visiting routine medical check in our clinic
Key exclusion criteria (5 listed)
- history of CVD (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
- stage 2 hypertension (resting blood pressure, ≥160/100 mmHg)
- history of inflammatory conditions that affect the study results
- taking medications that might affect inflammatory status, including steroid and non-steroidal anti-inflammatory drug within 6 months
- or malignancy or 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
max TBR values stratified by the four body size phenotypes
Time frame: 12 weeks
1 secondary outcome
Framingham risk scores according to the four body size phenotypes
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Derived from this study: PubMed 25529544Yoo HJ, Kim S, Hwang SY, Hong HC, Choi HY, Seo JA, Kim SG, Kim NH, Choi DS, Baik SH, Choi KM. Vascular inflammation in metabolically abnormal but normal-weight and metabolically healthy obese individuals analyzed with (1)(8)F-fluorodeoxyglucose positron emission tomography. Am J Cardiol. 2015 Feb 15;115(4):523-8. doi: 10.1016/j.amjcard.2014.11.036. Epub 2014 Nov 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atherosclerosis and Obesity, 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 1 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: finished, as of the sponsor's last update on 8 Nov 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
max TBR values stratified by the four body size phenotypes (time frame: 12 weeks). 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 NCT01979068, 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 8 Nov 2013.