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NCT03684213 · ClinicalTrials.gov registry record · Phase 1
Local Antioxidant Therapy Vasoconstriction Effects in Different Races
A Phase 1 study, sponsored by The University of Texas at Arlington.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT03684213 is a Phase 1 study that has completed, run by The University of Texas at Arlington. The registered enrollment target is 22 participants.
The verdict
NCT03684213, a Phase 1 study, has completed, sponsored by The University of Texas at Arlington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Cardiovascular disease (CVD) afflicts nearly one-third of the adult population with all races and ethnicities represented in CVD prevalence. Unfortunately, a disparity exists such that the black population (BL) is disproportionately affected compared to other groups, including the white population (WH). While the underlying cause of this disparity is multifactorial, vascular dysfunction (i.e., impaired vasodilation and/or augmented vasoconstriction) is a key contributor. As has been previously observed, BL exhibit a heightened vasoconstrictor response to both pharmacological (e.g., alpha-adrenergic receptor agonists) and environmental (e.g., cold pressor test) stimuli compared to their WH counterparts. Additionally, reactive oxygen species (ROS) and the subsequent reduction in nitric oxide (NO) bioavailability may partially mediate this response. Our laboratory has recently observed (UTA IRB 2016-0268) that the small blood vessels in the skin (cutaneous microvasculature) in BL, but otherwise healthy individuals, produce an impaired blood flow response to local heating when compared to age-, body mass index (BMI)-, and gender-matched WH. However, pre-treatment of the cutaneous microvasculature with various antioxidants abolishes this skin blood flow difference. These antioxidant drugs inhibit possible sources of ROS, which, as mentioned, maybe mediating the heightened vasoconstrictor response in BL. However, this has not been investigated in this population and thus remains unknown. Therefore, the purpose of this study proposal is to test the following hypotheses: 1) BL will have a greater reduction in cutaneous blood flow in response to local administration of Norepinephrine (alpha1-adrenergic and alpha 2-adrenergic receptor agonist) relative to WH. 2) This greater reduction in the BL population will be related to elevated oxidative stress and subsequent reduction in bioavailability of the potent vasodilator Nitric oxide.
Interventions
- DRUG Control (Norepinephrine)
- DRUG Norepinephrine + Ascorbic Acid
- DRUG Norepinephrine + L-NAME
- DRUG Norepinephrine + L-NAME + Ascorbic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-10-15 |
| Est. Completion | 2024-06-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03684213
The ClinicalTrials.gov registry entry for NCT03684213 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas at Arlington, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Control (Norepinephrine) is the first listed.
NCT03684213 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03684213 about?
NCT03684213 is a clinical study titled "Local Antioxidant Therapy Vasoconstriction Effects in Different Races". Cardiovascular disease (CVD) afflicts nearly one-third of the adult population with all races and ethnicities represented in CVD prevalence. Unfortunately, a disparity exists such that the black population (BL) is disproportionately affected compared to other groups, including the white population (...
What is the current status of trial NCT03684213?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2018-10-15. Estimated completion is 2024-06-08.
What interventions are being tested in trial NCT03684213?
The interventions under investigation include: Control (Norepinephrine) (DRUG), Norepinephrine + Ascorbic Acid (DRUG), Norepinephrine + L-NAME (DRUG), Norepinephrine + L-NAME + Ascorbic Acid (DRUG).
Who is sponsoring clinical trial NCT03684213?
This trial is sponsored by The University of Texas at Arlington, which has 32 total clinical trials registered on ClinicalTrials.gov.
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