Asymptomatic Patients With Type 2 Diabetes MellitusNCT02070926
The CRONOS-ADM Registry
An observational study of Asymptomatic Patients With Type 2 Diabetes Mellitus and Atherosclerosis, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
The CRONOS-ADM (Coronary CT angiography evaluation for clinical outcomes in asymptomatic patients with type 2 diabetes mellitus) registry is a large, prospective observational registry of demographic, clinical and laboratory data with long-term clinical outcome of asymptomatic diabetic patients without history of CAD… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asymptomatic Patients With Type 2 Diabetes Mellitus, Atherosclerosis, Coronary Artery Disease
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2006to Dec 2010
- How long will I take part?
- 3 Years
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population consist of patients with asymptomatic type 2 diabetes mellitus at two centers of catholic university of Korea
Who may be able to join
- Age > 18 years
- Asymptomatic type 2 diabetes mellitus
- Prospective data collection for CAD risk factors
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coronary CT Angiography Evaluation for Clinical Outcomes in Asymptomatic Patients With Type 2 Diabetes Mellitus
The CRONOS-ADM (Coronary CT angiography evaluation for clinical outcomes in asymptomatic patients with type 2 diabetes mellitus) registry is a large, prospective observational registry of demographic, clinical and laboratory data with long-term clinical outcome of asymptomatic diabetic patients without history of CAD or angina or angina-equivalent symptoms at two affiliated hospitals of The Catholic University of Korea.
- Conditions
- Asymptomatic Patients With Type 2 Diabetes Mellitus, Atherosclerosis, Coronary Artery Disease, Cardiovascular Disease
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease, Cardiovascular Diseases
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 |
|---|---|---|
| Perform coronary CT angiography | Not described | |
| Do not perform coronary CT angiography | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to major adverse events
Measured: up to median 3 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startJan 2006
- Primary completionDec 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 Asymptomatic Patients With Type 2 Diabetes MellitusStudies 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
- Prospective
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiyuk Chang, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070926
- Sponsor's protocol ID
- ADM CCTA
- Status last verified
- Feb 2014
- First submitted
- 23 Feb 2014
- Last updated
- 25 Feb 2014
- Results posted
- No
Publications
Lee EY, Yang HK, Lee J, Kang B, Yang Y, Lee SH, Ko SH, Ahn YB, Cha BY, Yoon KH, Cho JH. Triglyceride glucose index, a marker of insulin resistance, is associated with coronary artery stenosis in asymptomatic subjects with type 2 diabetes. Lipids Health Dis. 2016 Sep 15;15(1):155. doi: 10.1186/s12944-016-0324-2.
PubMed 27633375
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary CT Angiography Evaluation for Clinical Outcomes in Asymptomatic Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02070926
- Acronym / sponsor ID
- ADM CCTA
- Conditions
- Asymptomatic Patients With Type 2 Diabetes Mellitus, Atherosclerosis, Coronary Artery Disease, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2010 (actual)
- First posted
- 25 Feb 2014 (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 CRONOS-ADM (Coronary CT angiography evaluation for clinical outcomes in asymptomatic patients with type 2 diabetes mellitus) registry is a large, prospective observational registry of demographic, clinical and laboratory data with long-term clinical outcome of asymptomatic diabetic patients without history of CAD or angina or angina-equivalent symptoms at two affiliated hospitals of The Catholic University of Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perform coronary CT angiography | – | – |
| Do not perform coronary CT angiography | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consist of patients with asymptomatic type 2 diabetes mellitus at two centers of catholic university of Korea
Key inclusion criteria (3 listed)
- Age > 18 years
- Asymptomatic type 2 diabetes mellitus
- Prospective data collection for CAD risk factors
Key exclusion criteria (0 listed)
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
Time to major adverse events
Time frame: up to median 3 years follow up
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 25 Feb 2014.
- Derived from this study: PubMed 27633375Lee EY, Yang HK, Lee J, Kang B, Yang Y, Lee SH, Ko SH, Ahn YB, Cha BY, Yoon KH, Cho JH. Triglyceride glucose index, a marker of insulin resistance, is associated with coronary artery stenosis in asymptomatic subjects with type 2 diabetes. Lipids Health Dis. 2016 Sep 15;15(1):155. doi: 10.1186/s12944-016-0324-2.
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 Asymptomatic Patients With Type 2 Diabetes Mellitus and Atherosclerosis, run by Seoul St. Mary's 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 3 inclusion and 0 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 25 Feb 2014. 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?
Time to major adverse events (time frame: up to median 3 years follow up). 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 NCT02070926, 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 25 Feb 2014.