NCT05176379 Endothelial Derived Hyperpolarization Factor and Vascular Control
| NCT ID | NCT05176379 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Oklahoma |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-02-19 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2022-02-19 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Most cardiometabolic diseases are characterized by increased muscle sympathetic nerve activity (MSNA) during rest and exercise which contributes to poor health outcomes. In healthy humans during muscle contraction, there is a blunting of skeletal muscle vascular responsiveness to increases in MSNA. However, the exact mechanisms involved are unknown although, best evidence suggests that the mechanism is endothelium derived, but nitric oxide (NO) and prostaglandin (PG) independent. Endothelium-derived hyperpolarizing factor (EDHF) is a NO and PG independent vasodilator in both cerebral and skeletal muscle circulations, however, it is unknown if EDHF contributes to vascular responsiveness during elevated MSNA. The application of lower body negative pressure (LBNP) is a safe and non-invasive manipulation that can be used to increase MSNA causing vasoconstriction in humans. Therefore, the purpose of this experiment is to determine if acute inhibition of EDHF alters central and peripheral vascular responses to LBNP at rest and during dynamic exercise. Thereby, providing evidence by which EDHF contributes to vascular control in healthy humans and identify it's potential as a therapeutic target for cardiometabolic diseases that are characterized by elevated MSNA
Eligibility Criteria
Inclusion Criteria: * Normotensive (systolic blood pressure \< 130 mmHg and/or diastolic blood pressure \< 85 mmHg) individuals * Individuals free of cardiovascular disease and metabolic disease * Individuals free of any form of autonomic dysfunction * Individuals with a BMI under 30 kg/m² * Women that are premenopausal with a regular menstrual cycle (26-30 days) Exclusion Criteria: * Smokers, tobacco users (regular use in the last 6 months) * Individuals with a blood pressure greater than 130/85 * Subjects who use Amiodarone, Sulphaphenazole * Subjects who use S-warfarin, Tolbutamine, Phenytoin, Lonafarnib * Cardiometabolic medication use (e.g. anti-hypertensives, insulin-sensitizing, statins) * Sex hormone replacement medical use (e.g. testosterone, estrogen, progesterone) * Pregnancy
Contact & Investigator
Jeremy M Kellawan, PhD
PRINCIPAL INVESTIGATOR
University of Oklahoma
Frequently Asked Questions
Who can join the NCT05176379 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 30 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05176379 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05176379 currently recruiting?
Yes, NCT05176379 is actively recruiting participants. Contact the research team at kellawan@ou.edu for enrollment information.
Where is the NCT05176379 trial being conducted?
This trial is being conducted at Norman, United States.
Who is sponsoring the NCT05176379 clinical trial?
NCT05176379 is sponsored by University of Oklahoma. The principal investigator is Jeremy M Kellawan, PhD at University of Oklahoma. The trial plans to enroll 30 participants.