Diabetes, Metabolic Syndrome
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTCardiac CT
A cardiac CT involves a non-invasive test of the coronary arteries.
BEHAVIORALUsual medical care
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.
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Age \> 18 * Diabetes * Metabolic Syndrome
Exclusion criteria
* Symptoms of heart disease * Heart Disease * Renal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic BP Pressure | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Treatment by PCP | 2 years | Medication dose change or medication start/stop |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cardiac CT Group Asymptomatic patients with Type II DM who received cardiac CT screening test | 92 |
| Usual Care Group Asymptomatic patients with Type II DM who received usual care | 101 |
| Total | 193 |
Baseline characteristics
| Characteristic | Cardiac CT Group | Usual Care Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 10 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 85 Participants | 91 Participants | 176 Participants |
| Sex: Female, Male Female | 54 Participants | 58 Participants | 112 Participants |
| Sex: Female, Male Male | 38 Participants | 43 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 92 | 0 / 93 |
| serious Total, serious adverse events | 0 / 92 | 0 / 93 |
Outcome results
Primary
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.
Time frame: Five year follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardiac CT | Systolic BP Pressure | 145 mm Hg | Standard Deviation 6 |
| Usual Care | Systolic BP Pressure | 144 mm Hg | Standard Deviation 5 |
Other Pre-specified
Change in Treatment by PCP
Medication dose change or medication start/stop
Time frame: 2 years
Other Pre-specified
Change in Treatment by PCP
Medication dose change or medication start/stop
Time frame: 2 years