Testosterone Deficiency and Endothelial Dysfunction After Spinal Cord Injury

Recruiting now

Conditions studied: Spinal Cord Injuries, Endothelial Dysfunction, Testosterone Deficiency

In brief

Heart attacks and strokes are among the most common causes of premature death in individuals living with spinal cord injury (SCI) and appear to occur earlier in life. The factors that lead to the heighten and accelerated risk of heart attacks and strokes in adults living with SCI remain poorly understood. The investigators aim to uncover why this happens and find ways to prevent it. Our research focuses on how important cells which line blood vessels, called endothelial cells, function after SCI. The investigators test endothelial function in live conscious people with SCI. The investigators also study signaling molecules endothelial cells release called endothelial cell derived microvesicles (EMVs), which the investigators can measure in blood to tell us the health of endothelial cells. By using these rigorous tests of vascular function, the investigators have determined that endothelial cells appear dysfunctional after SCI. The investigators also know that many men with SCI have low testosterone levels. Our team has studied testosterone's effects on endothelial dysfunction and believe low testosterone may be contributing to endothelial dysfunction after SCI. By understanding these mechanisms, the investigators hope to improve the lives of those living with SCI and reduce their risk for heart attacks and strokes. The investigators propose to study the influence of testosterone on endothelial function by using state-of-the-art clinical and laboratory experiments to assess endothelial function in men with SCI with low and normal testosterone levels.

Key facts

Study ID

NCT07227740

Run by

Craig Hospital

People needed

48

Starts

2025-07-15

Expected to finish

2028-07-14

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older, up to 89. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Between ages 18-89 years of age
• Male Sex
• History of motor complete (AIS A/B) paraplegia (NLI T3 or Below)
• Time since injury <6 months at time of enrollment (Subacute injury)
• Testosterone Deficiency defined as < 300ng/dL

You may not qualify if…

• Overt cardiovascular disease assessed by a) medical history, b) physical examination c) electrocardiogram
• Anaphylaxis to betadine, lidocaine, iodine
• Active infection at time of enrollment.
• Recent surgery (<1 month) at time of enrollment.
• History smoking tobacco (currently or in the past 12 months)
• History of more than low-risk history of alcohol consumption
• History of drug abuse
• History of use of cardiovascular-acting (i.e. statins, beta-blockers) therapeutics
• History of other health habits, medications, and supplements that could influence the outcome measures deemed by principal investigators and investigative team.

Where it is running

• Craig Hospital — Englewood, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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