Testosterone Deficiency and Blood Vessel Health After Spinal Cord Injury
This study is looking into why people with spinal cord injuries (SCI) might have a higher and earlier risk of heart attacks and strokes. Researchers are studying how the cells lining your blood vessels, called endothelial cells, work after SCI. They will infuse small doses of medications like acetylcholine, isoproterenol, and sodium nitroprusside into your arm artery to measure blood flow. They will also infuse Vitamin C to see if it helps. About 50 mL of blood will be drawn to check for signs of blood vessel health and inflammation. This study aims to understand if low testosterone contributes to problems with blood vessels after SCI. To join, you must be a male between 18-89 years old with a motor complete spinal cord injury (paraplegia) that happened less than 6 months ago, and have low testosterone levels (below 300ng/dL). The study will look at how well your blood vessels widen and how your body breaks down blood clots.
- Study design
- This is an observational study, meaning researchers will be observing and collecting information without giving a specific treatment. It plans to include 48 male participants.
- What's involved
- You will have a catheter placed in your arm artery for infusions of various medications and Vitamin C. Blood flow will be measured, and about 50 mL of blood will be drawn from your arm.
- Compensation
- Not stated in the trial record.
- Follow-up
- Blood vessel function and clot-breaking ability will be measured at baseline and immediately after each medication dose for 3-5 minutes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Testosterone Deficiency and Endothelial Dysfunction After Spinal Cord Injury
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Andrew Park, MD · PRINCIPAL_INVESTIGATOR · Craig Hospital
Who to contact
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Inclusion
Exclusion
What this trial measures
- Endothelium-dependent vasodilationMeasured at baseline (without acetylcholine) and immediately after each acetylcholine dose for 3-5 minutes.
Total forearm blood flow with be measured by strain gauge venous plethysmography under baseline conditions and under pharmacological manipulation with acetylcholine at increasing concentrations (8, 16, 32ug/ml).
- Endothelium-independent vasodilationMeasured at baseline (without sodium nitroprusside) and immediately after each sodium nitroprusside dose for 3-5 minutes.
Total forearm blood flow with be measured by strain gauge venous plethysmography under baseline conditions and under pharmacological manipulation with sodium nitroprusside at increasing concentrations (1, 2, 4ug/ml).
- Tissue plasminogen activator releaseMeasured at baseline and immediately after each isoproterenol and sodium nitroprusside dose for 3-5 minutes.
Net endothelial release or uptake of t-PA and PAI-1 (both antigen and activity levels) at each dose of isoproterenol and sodium nitroprusside will be calculated as the product of the arteriovenous concentration gradient and the infused forearm plasma flow. Arteriovenous concentration gradients for both t-PA and PAI-1 antigen and activity for each subject (at each time point) will be determined by subtraction of the values measured in simultaneously collected venous and arterial blood samples
- Endothelial cell-derived microvesicles concentrationBaseline
Endothelial cell-derived microvesicles will be collected from venous blood samples and counted used flow cytometry to determine a circulating concentration.
- Endothelial cell-derived microvesicles effects of human coronary artery endothelial cells nitric oxide bioavailability.Baseline
Endothelial cell-derived microvesicles will be sorted and collected by fluorescence-activated cell sorting (FACS) flow cytometry. The endothelial cell-derived microvesicles will be co-cultured with human coronary artery endothelial cells. Endothelial Nitric Oxide Synthase and phosphorylation sites of interest will be measured by intracellular protein expression quantification of whole cell lysates by capillary electrophoresis immunoassays. Nitric oxide production will be assessed by total nitric oxide and nitrate/nitrite parameter assays
- Endothelial cell-derived microvesicles effects of human coronary artery endothelial cells reactive oxygen species and antioxidant capacityBaseline
Endothelial cell-derived microvesicles will be sorted and collected by fluorescence-activated cell sorting (FACS) flow cytometry. The endothelial cell-derived microvesicles will be co-cultured with human coronary artery endothelial cells. Super oxide dismutase and catalase expression will be measured by intracellular protein expression quantification of whole cell lysates by capillary electrophoresis immunoassays. Intracellular oxidative stress will be assessed by ROS-Glo H2O2 assay.