Diabetes
Conditions
Brief summary
Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse endothelium to begin with. One of the functions of the endothelium is to help control how blood vessels dilate (expand) or contract (narrow) in different situations. This affects how blood flows through those vessels. Magnetic resonance imaging (MRI) can be used to evaluate endothelial function in the arms and legs noninvasively.
Detailed description
Correct
Interventions
DRUGlipitor
80 mg everyday (QD) for 3 weeks
Sponsors
Pfizer
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age 40-90 * Male or female * Type 2 diabetes
Exclusion criteria
* Known pregnancy or nursing. * Females of child bearing potential must have been surgically sterilized or be post menopausal. * Smoking * Known vascular disease * Inability to complete MRI scan * Symptoms of claudication * Use of a nitrate medicine * Use of any cholesterol-lowering agent * LDL \< 70 * Acute illness * Liver disease * Contraindication to getting an MRI scan (i.e. electronic implant, shrapnel, cerebral aneurysm clip, welding history).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Low Density Lipoprotein (LDL) | Change from baseline to follow-up, up to 5 weeks | Serum LDL, mg/dL (baseline LDL-follow-up LDL) |
| Change in Endothelial Function as Measured on MRI in the Arms | chance from baseline to end of study, up to 5 weeks | — |
| Change in Endothelial Function as Measured on MRI in the Legs | chance from baseline to end of study, up to 5 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High-Dose Statin 80 mg atorvastatin daily for 3 weeks
lipitor: 80 mg everyday (QD) for 3 weeks | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Follow-up LDL measurement not collected | 3 |
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | High-Dose Statin |
|---|---|
| Age, Customized >=40, <=90, years | 16 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Change in Endothelial Function as Measured on MRI in the Arms
Time frame: chance from baseline to end of study, up to 5 weeks
Population: No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities.
Primary
Change in Endothelial Function as Measured on MRI in the Legs
Time frame: chance from baseline to end of study, up to 5 weeks
Population: No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities.
Primary
Mean Change in Low Density Lipoprotein (LDL)
Serum LDL, mg/dL (baseline LDL-follow-up LDL)
Time frame: Change from baseline to follow-up, up to 5 weeks
Population: 3 participants were lost to follow-up, 3 participants did not have LDL values collected/reported at follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-Dose Statin | Mean Change in Low Density Lipoprotein (LDL) | 75.54 mg/dL | Standard Deviation 12.98 |