Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT04769206

Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans

Led by Vanderbilt University Medical Center · Updated on 2026-05-05

160

Participants Needed

1

Research Sites

379 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Specific Aim 1: To test the hypothesis that prolonged (3-month) treatment with galantamine inhibits NADPH IsoLG-protein adducts formation and improves markers of endothelial cell (EC) dysfunction in AAs. Aim 1a: The investigators will determine if galantamine inhibits NADPH IsoLG-protein adducts formation, superoxide production, and immune cell activation compared to placebo. For this purpose, the investigators will study peripheral blood mononuclear cell (PBMC), a critical source of systemic oxidative stress, collected from study participants. Aim 1b: The investigators will determine if galantamine reduces intracellular Iso-LGs, ICAM-1, and 3-nitrotyrosine, a marker of vascular oxidative stress, in ECs harvested from study participants. Specific Aim 2: To determine if prolonged (3-month) treatment with galantamine improves endothelial dysfunction as measured by vascular reactivity in AAs. The investigators will measure vascular reactivity in response to ischemia in two vascular beds: (a) in conduit arteries (brachial artery) using brachial artery diameter flow-mediated dilation (FMD), and (b) in the microvasculature (MBV) using contrast-enhanced ultrasonography in skeletal muscle. Sub-study (optional) Will study the effect of trans-auricular vagus nerve stimulation (TaVNS) during a period of enhanced vascular oxidative stress This proposal will study a novel mechanism that could alter the oxidative and immunogenic responses that contributes to endothelial dysfunction in AAs and will offer a potential pathway for the development of more effective therapies aimed at decreasing the progression of endothelial dysfunction to cardiovascular disease in this population.

CONDITIONS

Official Title

Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • African American women and men
  • Age 18 to 60 years old
  • BMI >28
Not Eligible

You will not qualify if you...

  • History of myocardial infarction, angina, heart failure, stroke, transient ischemic attack, or cardiovascular surgery
  • Uncontrolled hypertension with blood pressure >140/90 despite medication
  • Diabetes mellitus type 1 or 2 or use of anti-diabetic medication
  • Use of nitrates
  • Impaired liver function or use of strong CYP3A4 and CYP2D6 inhibitors
  • Pregnancy or breastfeeding; women must use birth control or have tubal ligation
  • Post-menopausal women
  • Use of other central or peripheral acetylcholinesterase inhibitors
  • AV block detected on ECG
  • History of seizures
  • Current smoking within last 30 days
  • History of recurrent fainting
  • Serious neurological disease such as cerebral hemorrhage or stroke
  • History of cardiac shunts
  • Allergy to eggs or soy
  • Impaired liver enzymes (AST or ALT >3 times normal)
  • Impaired kidney function (eGFR <60)
  • Anemia (hematocrit <34%)
  • Ongoing substance abuse
  • Use of investigational drugs within 1 month
  • Mental conditions impairing understanding
  • Inability to comply with protocol or complete study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chaney Johnson

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

C

Cyndya Shibao, MD

CONTACT

C

Chaney Johnson, BSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans | DecenTrialz