Testosterone Deficiency and Endothelial Dysfunction After Spinal Cord Injury

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-89
SponsorCraig Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Intra-arterial Infusion of Vasoactive Agents
  • Intra-arterial Vitamin C Infusion
  • Blood Sampling

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Craig Hospital

Lead sponsor

University of Colorado, Boulder

Collaborator

Denver Health and Hospital Authority

Collaborator

University of Colorado, Denver

Collaborator