DiabetesCTRADNCT01564485
Cardiac CT's Role in Asymptomatic Patients With Diabetes and Metabolic Syndrome
A study testing Cardiac CT and Usual medical care in people with Diabetes and Metabolic Syndrome, run by University of California, Irvine at 1 site in United States.
Trial summary
This study looked at the role of cardiac CT in improving risk factor control in those with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Metabolic Syndrome
- What is being tested?
- Cardiac CT and Usual medical care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18
- Diabetes
- Metabolic Syndrome
Who cannot join
- Symptoms of heart disease
- Heart Disease
- Renal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center
Orange, California, 92868
About this study
Official title: Role of Cardiac CT in Risk Factor Control in Asymptomatic Patients With Diabetes
This study looked at the role of cardiac CT in improving risk factor control in those with diabetes.
Read the detailed description
This study examined whether doing a cardiac screening test, the cardiac CT, would result in patients paying more attention to controlling their risk factors.
- Conditions
- Diabetes, Metabolic Syndrome
- Being tested
- Cardiac CT, Usual medical care
- Medical subject headings
- Diabetes Mellitus, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CTDiagnostic test
A cardiac CT involves a non-invasive test of the coronary arteries.
Usual medical careBehavioural
Also called Usual medical care would include control of blood pressure, blood glucose, and cholesterol by the primary care physician.
Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac CT | Experimental | Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries. Receives: Diagnostic Test: Cardiac CT |
| Usual Care | Active comparator | Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician Receives: Behavioral: Usual medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic BP Pressure
After randomization to either obtain cardiac CT or usual care, patients will be followed for 5 years (with assessment of outcomes at every 6 months) to see any difference in control of systolic blood pressure. The outcome with be assessed as a continuous measure.
Measured: Five year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startJul 2008
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaista Malik, University of California, Irvine
- Investigators
- Shaista Malik, MD, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564485
- Sponsor's protocol ID
- 2008-6170
- Acronym
- CTRAD
- Status last verified
- Jun 2021
- First submitted
- 24 Feb 2012
- Last updated
- 8 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified data will be available
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cardiac CT in Risk Factor Control in Asymptomatic Patients With Diabetes
- ClinicalTrials.gov ID
- NCT01564485
- Acronym / sponsor ID
- CTRAD / 2008-6170
- Conditions
- Diabetes, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Posted 8 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study looked at the role of cardiac CT in improving risk factor control in those with diabetes.
Detailed description
This study examined whether doing a cardiac screening test, the cardiac CT, would result in patients paying more attention to controlling their risk factors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac CT | Experimental | Diagnostic Test: Cardiac CTPatients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries. |
| Usual Care | Active comparator | Behavioral: Usual medical carePatients randomized to usual care will be assigned to continuing usual medical care with their primary care physician |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- Diabetes
- Metabolic Syndrome
Key exclusion criteria (3 listed)
- Symptoms of heart disease
- Heart Disease
- Renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac CTA cardiac CT involves a non-invasive test of the coronary arteries. | Diagnostic test | Cardiac CT |
| Usual medical careAlso: Usual medical care would include control of blood pressure, blood glucose, and cholesterol by the primary care physician.Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion. | Behavioural | Usual Care |
Primary outcome
Systolic BP Pressure
Time frame: Five year follow up
After randomization to either obtain cardiac CT or usual care, patients will be followed for 5 years (with assessment of outcomes at every 6 months) to see any difference in control of systolic blood pressure. The outcome with be assessed as a continuous measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified data will be available
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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.
Shaista Malik, MD, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac CT and Usual medical care in people with Diabetes and Metabolic Syndrome, run by University of California, Irvine at 1 site in United States.
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 3 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 Jun 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Systolic BP Pressure (time frame: Five year follow up). 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 8 Jun 2021.