AtherosclerosisNCT01099865
High-sensitivity C-reactive Protein and United Kingdom Prospective Diabetes Study (UKPDS) Risk Score in Type 2 Diabetes
An observational study of Atherosclerosis and Type 2 Diabetes, run by Korea University at 1 site in South Korea.
Trial summary
The UKPDS risk score is recommended to assess global risk for future coronary heart disease (CHD) events in primary prevention. Recently, high-sensitivity C-reactive protein (hsCRP) has emerged as a strong independent risk factor for CHD. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Atherosclerosis, Type 2 Diabetes
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Apr 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 diabetes
Who may be able to join
- Type 2 diabetes
Who cannot join
- Myocardial infarction, unstable angina, stroke, peripheral artery disease, or cardiovascular revascularization
- Resting blood pressure ≥160/100 mmHg
- Malignancy, or severe renal or hepatic disease
- Participants were free of any lipid-lowering therapies and postmenopausal hormone replacement therapy at least the 6 month period prior to enrollment
- History of inflammatory condition or those taking medications that might affect inflammatory status within 6 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Guro Hospital Dept. of Endocrinology
Seoul
About this study
Official title: High-sensitivity C-reactive Protein and UKPDS Risk Score in Type 2 Diabetes: Nalysis With 18F-Fluorodeoxyglucose Positron Emission Tomography
The UKPDS risk score is recommended to assess global risk for future coronary heart disease (CHD) events in primary prevention. Recently, high-sensitivity C-reactive protein (hsCRP) has emerged as a strong independent risk factor for CHD. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising imaging technique for the evaluation of vascular inflammation that reflects vulnerable atherosclerotic plaque.
- Conditions
- Atherosclerosis, Type 2 Diabetes
- Medical subject headings
- Atherosclerosis, Diabetes Mellitus, Type 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startDec 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099865
- Sponsor's protocol ID
- PET(DM)
- Status last verified
- Apr 2010
- First submitted
- 7 Apr 2010
- Last updated
- 8 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-sensitivity C-reactive Protein and UKPDS Risk Score in Type 2 Diabetes: Nalysis With 18F-Fluorodeoxyglucose Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT01099865
- Acronym / sponsor ID
- PET(DM)
- Conditions
- Atherosclerosis, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 Apr 2010 (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.
The UKPDS risk score is recommended to assess global risk for future coronary heart disease (CHD) events in primary prevention. Recently, high-sensitivity C-reactive protein (hsCRP) has emerged as a strong independent risk factor for CHD. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising imaging technique for the evaluation of vascular inflammation that reflects vulnerable atherosclerotic plaque.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- type 2 diabetes
Key inclusion criteria (1 listed)
- Type 2 diabetes
Key exclusion criteria (5 listed)
- Myocardial infarction, unstable angina, stroke, peripheral artery disease, or cardiovascular revascularization
- Resting blood pressure ≥160/100 mmHg
- Malignancy, or severe renal or hepatic disease
- Participants were free of any lipid-lowering therapies and postmenopausal hormone replacement therapy at least the 6 month period prior to enrollment
- History of inflammatory condition or those taking medications that might affect inflammatory status within 6 months
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 8 Apr 2010.
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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 Type 2 Diabetes, 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 Apr 2010. 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.
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 8 Apr 2010; AzTrials last refreshed its copy on 7 Nov 2026.