Testosterone Deficiency and Endothelial Dysfunction After Spinal Cord Injury

Part of paid clinical trials in Englewood, Colorado.

Sponsor
Craig Hospital
Study ID
NCT07227740
Status
Recruiting
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Conditions

  • Endothelial Dysfunction
  • Spinal Cord Injuries
  • Testosterone Deficiency

Eligibility Criteria

Sex
MALE
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Intra-arterial Infusion of Vasoactive Agents — DIAGNOSTIC_TEST
    A catheter is placed in the brachial artery of the non-dominant arm, and small doses of vasoactive drugs acetylcholine, isoproterenol, sodium nitroprusside are infused. Forearm blood flow will be measured using venous occlusion plethysmography. The purpose of this procedure is to assess endothelium-dependent and independent vasodilation by stimulating different vascular pathways. The acetylcholine infusion is to test muscarinic receptor, nitro oxide dependent, endothelium-dependent vasodilation. Isoproterenol was selected to stimulate tissue plasminogen activator based on its specificity and effectiveness at eliciting local and rapid tissue plasminogen activator release in adult humans. Sodium nitroprusside infusion is to assess endothelium-independent vasodilation.
  • Intra-arterial Vitamin C Infusion — DIAGNOSTIC_TEST
    Vitamin C, a potent antioxidant, will be infused into the forearm and forearm blood flow will be re-evaluated to determine whether oxidative stress contributes to endothelial dysfunction.
  • Blood Sampling — DIAGNOSTIC_TEST
    Blood will be sampled from the antecubital vein (\~50 mL) for biomarker analysis. This is to assess circulating biochemical and molecular indicators of vascular health and inflammation including levels of endothelial cell derived microvesicles.

Study Details

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 Dates

Start date
Jul 15, 2025
Status verified
Nov 2025
Primary completion
Jul 14, 2028
Completion
Jul 14, 2028

Study Design

Enrollment
48 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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

Primary Outcome Measure

Endothelium-dependent vasodilation [ Time Frame: Measured at baseline (without acetylcholine) and immediately after each acetylcholine dose for 3-5 minutes. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Craig HospitalEnglewoodColorado80113
Genevieve Madera, BS
[email protected]
7203454640
Andrew Park, MD
[email protected]
303-789-8101
Andrew Park, MD (PRINCIPAL_INVESTIGATOR)
Christopher DeSouza, PhD (SUB_INVESTIGATOR)
Brian Stauffer, MD (SUB_INVESTIGATOR)
Josh Yarrow (SUB_INVESTIGATOR)
Kerrie Moreau (SUB_INVESTIGATOR)

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