Diabetes MellitusALTONCT01264263
Prevalence of Subclinical Atherosclerosis and Its Associated Factors in Hyperlipidemic Korean Adults With Diabetes
An observational study of Diabetes Mellitus and Dyslipidemia, run by AstraZeneca at 3 sites in South Korea.
Trial summary
This study is to investigate correlation between Carotid Intima Media Thickness (cIMT) and several factors such as; hs C-reactive protein (CRP), HbA1c, lipid profile in Korean diabetic patients with atherosclerosis. Total 360 patients will be enrolled through 6 sites. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Dyslipidemia
- How many people
- 181 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jan 2011to Apr 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
- No healthy volunteers
- Adult, Older adult
Study population: 360 patients who has diabetic mellitus with dyslipidemia
Who may be able to join
- patients with Diabetic Mellitus
- patients with dyslipidemia
Who cannot join
- patients who have established cardiovascular disease
- patient using NSAID
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Research Site
Anyang
Research Site
Koyang
Research Site
Seoul
About this study
This study is to investigate correlation between Carotid Intima Media Thickness (cIMT) and several factors such as; hs C-reactive protein (CRP), HbA1c, lipid profile in Korean diabetic patients with atherosclerosis. Total 360 patients will be enrolled through 6 sites.
Read the detailed description
MC MD
- Conditions
- Diabetes Mellitus, Dyslipidemia
- Keywords
- cIMT, hs CRP (C-reactive protein), DM (Diabetic Mellitus), Korea, Corelation between cIMT (carotid intima media thickness), Cardio Vascular risk in Diabetic Mellitus
- Medical subject headings
- Diabetes Mellitus, Dyslipidemias
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 |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of intima media thickness, visit 1
Measured: Visit 1
Measurement of intima media thickness, visit 2
Measured: Visit 2
Secondary outcomes (2)
hs-C-Reactive Protein, visit 1
Measured: Visit 1
hs-C-Reactive Protein, visit 2
Measured: Visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionApr 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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dongsun Kim, Study chair, Hanyang UniversityEunkyung Hong, Principal investigator, Hallym University Kangnam Sacred Heart HospitalHyunsang Kwon, Principal investigator, Yeoido Saint Mary's HospitalDongjoon Kim, Principal investigator, Ilsan-Paik HospitalSungjin Lee, Principal investigator, Hallym University HospitalSingon Kim, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264263
- Sponsor's protocol ID
- NIS-CKR-DUM-2010/1
- Acronym
- ALTO
- Status last verified
- Mar 2012
- First submitted
- 17 Dec 2010
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hong EG, Ohn JH, Lee SJ, Kwon HS, Kim SG, Kim DJ, Kim DS. Clinical implications of carotid artery intima media thickness assessment on cardiovascular risk stratification in hyperlipidemic Korean adults with diabetes: the ALTO study. BMC Cardiovasc Disord. 2015 Oct 6;15:114. doi: 10.1186/s12872-015-0109-y.
PubMed 26438201
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Subclinical Atherosclerosis and Its Associated Factors in Hyperlipidemic Korean Adults With Diabetes
- ClinicalTrials.gov ID
- NCT01264263
- Acronym / sponsor ID
- ALTO / NIS-CKR-DUM-2010/1
- Conditions
- Diabetes Mellitus, Dyslipidemia
- Keywords
- cIMT, hs CRP (C-reactive protein), DM (Diabetic Mellitus), Korea, Corelation between cIMT (carotid intima media thickness), Cardio Vascular risk in Diabetic Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 21 Dec 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.
This study is to investigate correlation between Carotid Intima Media Thickness (cIMT) and several factors such as; hs C-reactive protein (CRP), HbA1c, lipid profile in Korean diabetic patients with atherosclerosis. Total 360 patients will be enrolled through 6 sites.
Detailed description
MC MD
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 360 patients who has diabetic mellitus with dyslipidemia
Key inclusion criteria (2 listed)
- patients with Diabetic Mellitus
- patients with dyslipidemia
Key exclusion criteria (2 listed)
- patients who have established cardiovascular disease
- patient using NSAID
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
Measurement of intima media thickness, visit 1
Time frame: Visit 1
Measurement of intima media thickness, visit 2
Time frame: Visit 2
2 secondary outcomes
hs-C-Reactive Protein, visit 1
Time frame: Visit 1
hs-C-Reactive Protein, visit 2
Time frame: Visit 2
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 13 Mar 2012.
- Derived from this study: PubMed 26438201Hong EG, Ohn JH, Lee SJ, Kwon HS, Kim SG, Kim DJ, Kim DS. Clinical implications of carotid artery intima media thickness assessment on cardiovascular risk stratification in hyperlipidemic Korean adults with diabetes: the ALTO study. BMC Cardiovasc Disord. 2015 Oct 6;15:114. doi: 10.1186/s12872-015-0109-y.
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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.
Dongsun Kim study chair
Hanyang University
Eunkyung Hong principal investigator
Hallym University Kangnam Sacred Heart Hospital
Hyunsang Kwon principal investigator
Yeoido Saint Mary's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Dyslipidemia, run by AstraZeneca at 3 sites 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 2 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 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Measurement of intima media thickness, visit 1 (time frame: Visit 1). The study lists 2 primary outcomes in all. 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 NCT01264263, 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 13 Mar 2012.