Antioxidant Therapy for Cardiovascular Disease Vasoconstriction Effects

Phase 1

Recruiting

Research Sponsored by The University of Texas at Arlington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trialinvestigates why Black people are disproportionately affected by cardiovascular disease compared to other populations. The underlying cause may be vascular dysfunction, which may be caused by elevated oxidative stress and reduction of nitric oxide bioavailability.

Who is the study for?

This trial is for healthy individuals aged 18-35 from the Arlington area, who self-report as African American or Caucasian American. Exclusions include prescription medication users, BMI over 30, current/past smokers within two years, recent significant blood donors, and those with irregular menstrual cycles or certain cardiovascular/metabolic conditions.Check my eligibility

What is being tested?

The study tests how different races respond to vasoconstriction induced by Norepinephrine alone and in combination with L-NAME (blocks nitric oxide production) and Ascorbic Acid (Vitamin C). It aims to understand if oxidative stress affects blood flow reduction differently between black and white participants.See study design

What are the potential side effects?

Potential side effects may include local reactions at the drug application site such as redness or irritation. Systemic side effects are not expected due to localized treatment but could theoretically involve changes in blood pressure or heart rate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Role of Oxidative Stress in Heightened Vasoconstriction using Laser Doppler Fluxmetry

Vasoconstrictor Responsiveness to Norepinephrine using Laser Doppler Fluxmetry

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Norepinephrine + L-NAME + Ascorbic AcidExperimental Treatment1 Intervention

Subjects will be coinfused with the same norepinephrine concentrations as the control arm and combined L-NAME (Nω-Nitro-L-arginine methyl ester hydrochloride; 20 mM) and ascorbic acid (Vitamin C; 10 mM) at the same rate and for the same time as the control arm.

Group II: Norepinephrine + L-NAMEExperimental Treatment1 Intervention

Subjects will be coinfused with the same norepinephrine concentrations as the control arm and L-NAME (Nω-Nitro-L-arginine methyl ester hydrochloride; 20 mM) at the same rate and for the same time as the control arm.

Group III: Norepinephrine + Ascorbic AcidExperimental Treatment1 Intervention

Subjects will be coinfused with the same norepinephrine concentrations as the control arm and ascorbic acid (Vitamin C; 10 mM) at the same rate and for the same time as the control arm.

Group IV: Control (Norepinephrine)Active Control1 Intervention

Subjects will be administered norepinephrine at varying concentrations (10^-2 to 10^-8 M phenylephrine) at a rate of 2 microliters/minute for 10 minutes at each dose to construct a dose-response curve.

Do I qualify?Apply below to find out