Investigating the role of a specific factor in blood flow regulation
Endothelial Derived Hyperpolarization Factor and Regulation of Cerebral and Muscle Blood Flow
This study is testing how blocking a specific factor in the body affects blood flow to muscles and the brain during exercise and stress in healthy people.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Norman, Oklahoma) |
| Trial ID | NCT05176379 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the role of endothelium-derived hyperpolarizing factor (EDHF) in regulating blood flow to muscles and the brain during periods of sympathetic activation and exercise. Using lower body negative pressure (LBNP) to simulate increased sympathetic nerve activity, the researchers will assess how inhibiting EDHF affects cardiovascular responses and tissue oxygenation. The study will involve comparing physiological responses under placebo and acute EDHF inhibition using Fluconazole. The findings could enhance our understanding of vascular control mechanisms in healthy individuals.
Who should consider this trial
Good fit: Ideal candidates are normotensive, premenopausal women with a BMI under 30, free from cardiovascular and metabolic diseases.
Not a fit: Patients with cardiovascular or metabolic diseases, those on specific medications, or pregnant women are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to new therapeutic strategies for managing cardiovascular complications associated with cardiometabolic diseases.
How similar studies have performed: While the specific role of EDHF in this context is less explored, similar studies investigating vascular control mechanisms have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Norman, Oklahoma
- Department of Health and Exercise Science — Norman, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Jeremy M Kellawan, PhD — University of Oklahoma
- Study coordinator: Jeremy M Kellawan, PhD
- Email: kellawan@ou.edu
- Phone: 4053259028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.