sRAGE LevelNCT01021514
Association Between Arterial Wall Uptake of Fluorodeoxyglucose on PET Imaging and sRAGE
An observational study of sRAGE Level and SUV and TBR Levels in FDG PET, run by Korea University.
Trial summary
Arteriosclerosis is a dynamic inflammatory disorder. Recently, FDG-PET CT is emerging diagnostic tool of non-invasive technique to detect vulnerable atherosclerotic plaque. And there are arising evidence that sRAGE(soluble Receptor for Advanced glycation End Product) is correlated with metabolic risk. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- sRAGE Level, SUV and TBR Levels in FDG PET
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Nov 2010
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: type 2 DM diagnoed according to critereia of American Diabetes Asociation.
Who may be able to join
- Clinical diagnosis od type 2 DM
Who cannot join
- Type 1 DM
- Gestational Diabetes
- Severe Liver or Renal disease
- Diagnosis of cancer
- Trauma
- Acute infection or inflammatory disease
Show all 12Show fewer
- Acute vasculitis or history of vasculitis
- Pregnant or Lactating women
- Dyslipidemia(active state)
- Cardiovascular disease or history of CVD
- Chronic obstructive pulmonary disease
- Any patient by judge of investigator
About this study
Arteriosclerosis is a dynamic inflammatory disorder. Recently, FDG-PET CT is emerging diagnostic tool of non-invasive technique to detect vulnerable atherosclerotic plaque. And there are arising evidence that sRAGE(soluble Receptor for Advanced glycation End Product) is correlated with metabolic risk. So the investigators will investigate association between sRAGE and FDG-PET uptake in large artery in healthy patient.
- Conditions
- sRAGE Level, SUV and TBR Levels in FDG PET
- Keywords
- sRAGE, SUV, TBR, FDG PET CT, Type 2 DM
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 |
|---|---|---|
| Type 2 DM, Healthy control | Type 2 DM patients are treating in the Diabetic Clinic of Korea university Guro hospital, and their age- and sex-matched healthy controls are underwent a routine health checkup at Korea university Guro hospital. | |
| Type 2 DM, Heatlhy control | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2010
- Study completionNov 2010
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 sRAGE LevelStudies 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
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Investigators
- Kyoungmook Choi, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021514
- Sponsor's protocol ID
- PET(RAGE)
- Status last verified
- Apr 2011
- First submitted
- 27 Nov 2009
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang SJ, Kim S, Hwang SY, Kim TN, Choi HY, Yoo HJ, Seo JA, Kim SG, Kim NH, Baik SH, Choi DS, Choi KM. Association between sRAGE, esRAGE levels and vascular inflammation: analysis with (18)F-fluorodeoxyglucose positron emission tomography. Atherosclerosis. 2012 Feb;220(2):402-6. doi: 10.1016/j.atherosclerosis.2011.11.008. Epub 2011 Nov 16.
PubMed 22137663
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Arterial Wall Uptake of Fluorodeoxyglucose on PET Imaging and sRAGE
- ClinicalTrials.gov ID
- NCT01021514
- Acronym / sponsor ID
- PET(RAGE)
- Conditions
- sRAGE Level, SUV and TBR Levels in FDG PET
- Keywords
- sRAGE, SUV, TBR, FDG PET CT, Type 2 DM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 30 Nov 2009 (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.
Arteriosclerosis is a dynamic inflammatory disorder. Recently, FDG-PET CT is emerging diagnostic tool of non-invasive technique to detect vulnerable atherosclerotic plaque. And there are arising evidence that sRAGE(soluble Receptor for Advanced glycation End Product) is correlated with metabolic risk. So the investigators will investigate association between sRAGE and FDG-PET uptake in large artery in healthy patient.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 DM, Healthy control | – | –Type 2 DM patients are treating in the Diabetic Clinic of Korea university Guro hospital, and their age- and sex-matched healthy controls are underwent a routine health checkup at Korea university Guro hospital. |
| Type 2 DM, Heatlhy control | – | – |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- type 2 DM diagnoed according to critereia of American Diabetes Asociation.
Key inclusion criteria (1 listed)
- Clinical diagnosis od type 2 DM
Key exclusion criteria (12 listed)
- Type 1 DM
- Gestational Diabetes
- Severe Liver or Renal disease
- Diagnosis of cancer
- Trauma
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
Not reported in the source record.
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 6 Apr 2011.
- Derived from this study: PubMed 22137663Yang SJ, Kim S, Hwang SY, Kim TN, Choi HY, Yoo HJ, Seo JA, Kim SG, Kim NH, Baik SH, Choi DS, Choi KM. Association between sRAGE, esRAGE levels and vascular inflammation: analysis with (18)F-fluorodeoxyglucose positron emission tomography. Atherosclerosis. 2012 Feb;220(2):402-6. doi: 10.1016/j.atherosclerosis.2011.11.008. Epub 2011 Nov 16.
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.
Kyoungmook Choi, MD, PhD principal investigator
Korea University Guro Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of sRAGE Level and SUV and TBR Levels in FDG PET, run by Korea University.
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 12 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 6 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01021514, 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 6 Apr 2011.