Testosterone and blood vessel health after spinal cord injury
Testosterone Deficiency and Endothelial Dysfunction in Spinal Cord Injury Related Cardiovascular Disease Mechanistic Insights and Therapeutic Prospects
This research tests if low testosterone in men with recent motor-complete paraplegia is linked to poorer blood vessel function and higher blood markers of endothelial injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | Male |
| Sponsor | Craig Hospital Academic / other |
| Locations | 1 site (Englewood, Colorado) |
| Trial ID | NCT07227740 on ClinicalTrials.gov |
What this trial studies
This cross-sectional study will enroll 48 men with subacute (<6 months) motor-complete paraplegia (neurological level T3 or below), with 24 participants who have low testosterone (<300 ng/dL) and 24 with normal levels. Investigators will measure endothelium-dependent vasodilation and t-PA release using intra-arterial infusions of vasoactive agents while recording forearm blood flow, and will analyze endothelial cell–derived microvesicles and other blood biomarkers. Some participants will receive intra-arterial vitamin C to probe the role of oxidative stress in vascular responses. The study compares vascular function and circulating markers between the low-T and normal-T groups to see if testosterone deficiency helps explain early vascular risk after SCI.
Who should consider this trial
Good fit: Men aged 18–89 with motor-complete paraplegia (NLI T3 or below) within 6 months of injury who can have blood tests to determine testosterone status are the intended participants.
Not a fit: People with overt cardiovascular disease, recent surgery or active infection, current or recent tobacco use, use of cardiovascular-acting medications, women, those with incomplete or chronic (>6 months) injuries, or those with contraindications to intra-arterial procedures are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this work could point to testosterone as a modifiable factor and identify blood tests that flag early vascular trouble so heart attacks and strokes might be prevented in people with SCI.
How similar studies have performed: Prior studies have documented endothelial dysfunction and a high prevalence of low testosterone after SCI, but few have directly compared vascular function by testosterone status or used endothelial microvesicles as blood markers, so this approach is partly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Englewood, Colorado
- Craig Hospital — Englewood, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Park, MD — Craig Hospital
- Study coordinator: Genevieve Madera, BS
- Email: Gmadera@craighospital.org
- Phone: 17203454640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.