Obesity
Conditions
Keywords
Obesity, Endothelial Function, Fibrinolytic Balance, Baseline
Brief summary
T-PA release is impaired in obese subjects. In order to have a better mechanistic understanding of t-PA release, we will compare t-PA release to Flow Mediated Vasodilation, Radial Artery Tonometry, and other markers of endothelial function and oxidative stress.
Interventions
DRUGBradykinin
Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose.
Sponsors
Vanderbilt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adults 18 years and greater 2. Healthy
Exclusion criteria
1. PVC \< 30 2. Hypertensive subjects on ACE inhibitors 3. Pregnant or nursing mothers 4. Diabetic with HbA1C \> 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy) 5. Cholesterol \> 30 mg/dL above NCEP accepted level based on cardiac risk. 6. Triglycerides \> 200 7. Previously diagnosed obstructive coronary artery disease, myocardial infarction or left ventricular dysfunction (with or without a history of congestive heart failure) 8. Renal insufficiency (Creatinine ≥ 1.5 mg/dl) 9. History of cerebrovascular disease 10. Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc) 11. Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease). 12. Angiotensin converting enzyme inhibitor use 13. Coagulopathy (INR ≥ 1.5, PTT ≥ 1.5 x control) 14. Other chronic medical illnesses at the discretion of the investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak t-PA Release | Single Study day | tPA Release |
Secondary
| Measure | Time frame |
|---|---|
| Peak FMD | Single Study Day |
| Radial Artery Elasticity | Single Study Visit |
| Lipid Levels, PAI-1 Levels, CRP Levels, F2 Isoprostanes and Other Biomarkers of Inflammation and Obesity. | Single Study Day |
Countries
United States
Participant flow
Pre-assignment details
The data for this study was lost. The total number of participants enrolled/completed was pulled from IRB records. Participant age was between 18-65 per protocol. All participants were enrolled in the United States. No other data is available
Participants by arm
| Arm | Count |
|---|---|
| Bradykinin Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.
Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Bradykinin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Region of Enrollment United States | 13 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Peak t-PA Release
tPA Release
Time frame: Single Study day
Population: Data was lost
Secondary
Lipid Levels, PAI-1 Levels, CRP Levels, F2 Isoprostanes and Other Biomarkers of Inflammation and Obesity.
Time frame: Single Study Day
Population: Data was lost
Secondary
Peak FMD
Time frame: Single Study Day
Population: Data Lost
Secondary
Radial Artery Elasticity
Time frame: Single Study Visit
Population: Data was lost