Testosterone Deficiency and Endothelial Dysfunction in Spinal Cord Injury Related Cardiovascular Disease Mechanistic Insights and Therapeutic Prospects

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
Craig Hospital
RECRUITING
Englewood
Contact Information
Primary
Genevieve Madera, BS
Gmadera@craighospital.org
17203454640
Backup
Andrew Park, MD
apark@craighospital.org
303-789-8101
Time Frame
Start Date: 2025-07-15
Estimated Completion Date: 2028-07-14
Participants
Target number of participants: 48
Treatments
Adult Male with Subacute Traumatic Spinal Cord Injury with Normal Testosterone
24 male participants of all races and ethnic backgrounds aged 18-89 years with a history of spinal cord injury and diagnosed with normal testosterone
Adult Male with Subacute Traumatic Spinal Cord Injury with Low Testosterone
24 male participants of all races and ethnic backgrounds aged 18-89 years with a history of spinal cord injury and diagnosed with low testosterone
Sponsors
Leads: Craig Hospital
Collaborators: University of Colorado, Boulder, Denver Health and Hospital Authority, University of Colorado, Denver

This content was sourced from clinicaltrials.gov