Testosterone and blood vessel health after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.