Type 2 DiabetesNCT00949169
Carotid Intima-media Thickness (IMT) and Large-vessel Atherosclerosis by Multidetector Computed Tomography (MDCT)
An observational study of Type 2 Diabetes, run by Eulji University Hospital at 1 site in South Korea.
Trial summary
The aim of this study was to investigate whether carotid IMT can predict the presence of more advanced atherosclerosis such as carotid stenosis, coronary or intracranial artery disease by MDCT and whether MDCT could be useful next step for more aggressive treatment modality in Korean type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 71 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2006to Jul 2007
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: type 2 diabetic patients who had multiple cardiovascular risk factors
Who may be able to join
- Type 2 diabetic patients who had multiple cardiovascular risk factors were recruited.
- Patients who had atypical chest pain, EKG abnormality (ischemic ST-T changes or abnormal Q-wave), or history of previous cardiovascular disease were also included.
Who cannot join
- Acute coronary SD, serum Cr>1.4 mg/dL, history of allergy to iodinated contrast dye were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Carotid IMT and Large-vessel Atherosclerosis by MDCT in Korean Type 2 Diabetic Patients
The aim of this study was to investigate whether carotid IMT can predict the presence of more advanced atherosclerosis such as carotid stenosis, coronary or intracranial artery disease by MDCT and whether MDCT could be useful next step for more aggressive treatment modality in Korean type 2 diabetic patients.
Read the detailed description
We evaluated mean/maximal carotid IMT in seventy-one type 2 diabetic subjects, and defined increased carotid IMT as maximal IMT ≥ 1.0 mm. Multidetector CT (MDCT) and pulse wave velocity (PWV) were taken to evaluate carotid artery stenosis (CS), coronary artery disease (CAD), intracranial arterial lesion (ICA), and peripheral artery disease (PAD). We compared prevalence of large artery stenosis according to carotid IMT group and evaluated whether maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT. We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods.
- Conditions
- Type 2 Diabetes
- Keywords
- Atherosclerosis, Carotid IMT, Multidetector CT, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Atherosclerosis
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 |
|---|---|---|
| Carrotid IMT group according to maximal IMT | We defined increased IMT group as whom had maximal IMT ≥ 1.0 mm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
We compared prevalence of large artery stenosis according to carotid IMT group and evaluated whether maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT.
Measured: 17 months
Secondary outcomes (1)
We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods.
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startApr 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eulji University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kyung Wan Min, MD., PhD., Principal investigator, Department of Internal Medicine, Eulji University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949169
- Sponsor's protocol ID
- Eulji07-34
- Status last verified
- Jul 2009
- First submitted
- 29 Jul 2009
- Last updated
- 30 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Carotid IMT and Large-vessel Atherosclerosis by MDCT in Korean Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00949169
- Acronym / sponsor ID
- Eulji07-34
- Conditions
- Type 2 Diabetes
- Keywords
- Atherosclerosis, Carotid IMT, Multidetector CT, Type 2 diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Eulji University HospitalUniversity, hospital or other
- Study start
- Apr 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 30 Jul 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.
The aim of this study was to investigate whether carotid IMT can predict the presence of more advanced atherosclerosis such as carotid stenosis, coronary or intracranial artery disease by MDCT and whether MDCT could be useful next step for more aggressive treatment modality in Korean type 2 diabetic patients.
Detailed description
We evaluated mean/maximal carotid IMT in seventy-one type 2 diabetic subjects, and defined increased carotid IMT as maximal IMT ≥ 1.0 mm. Multidetector CT (MDCT) and pulse wave velocity (PWV) were taken to evaluate carotid artery stenosis (CS), coronary artery disease (CAD), intracranial arterial lesion (ICA), and peripheral artery disease (PAD). We compared prevalence of large artery stenosis according to carotid IMT group and evaluated whether maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT. We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carrotid IMT group according to maximal IMT | – | –We defined increased IMT group as whom had maximal IMT ≥ 1.0 mm. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- type 2 diabetic patients who had multiple cardiovascular risk factors
Key inclusion criteria (2 listed)
- Type 2 diabetic patients who had multiple cardiovascular risk factors were recruited.
- Patients who had atypical chest pain, EKG abnormality (ischemic ST-T changes or abnormal Q-wave), or history of previous cardiovascular disease were also included.
Key exclusion criteria (1 listed)
- Acute coronary SD, serum Cr>1.4 mg/dL, history of allergy to iodinated contrast dye were excluded.
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
We compared prevalence of large artery stenosis according to carotid IMT group and evaluated whether maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT.
Time frame: 17 months
1 secondary outcome
We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods.
Time frame: 17 months
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 30 Jul 2009.
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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.
Kyung Wan Min, MD., PhD. principal investigator
Department of Internal Medicine, Eulji University Hospital
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 Type 2 Diabetes, run by Eulji University Hospital 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 1 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 30 Jul 2009. 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?
We compared prevalence of large artery stenosis according to carotid IMT group and evaluated whether maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT. (time frame: 17 months). 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 30 Jul 2009.