NCT06499844 Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation
| NCT ID | NCT06499844 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Iowa |
| Condition | Endothelial Function |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2025-08-12 |
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 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 56 participants in total. It began in 2024-08-01 with a primary completion date of 2025-08-12.
⚠ 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
The increase in skin blood flow in response to rapid local heating of the skin (i.e., cutaneous vasodilation) is commonly used to assess nitric oxide (NO)-dependent dilation and overall microvascular function. Historically, rapid local heating to 42°C was considered the standard approach for these assessments. More recently, many investigators have adopted rapid local to 39°C instead, based on its larger dependency on NO and therefore improved ability to quantify NO-dependent dilation without the use of pharmacological techniques. However, to date, only one direct methodological comparison between these protocols has been performed. In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a nickel-sized area of the skin in young adults ages 18 - 30 years old. Local heating of the skin at the microdialysis sites is used to explore differences in mechanisms governing microvascular control. As a compliment to these measurements, the investigators also have participants fill out a variety of surveys to assess things such as sleep quality, physical activity, daily stressors, etc.
Eligibility Criteria
Inclusion Criteria: * men and women * 18-30 years of age Exclusion Criteria: * Current or recent (within 8 wks) use of medication that could conceivably alter microvascular function \[including (but not limited to) stimulants, antihypertensives, HMG-CoA reductase inhibitors\] * Changes or alterations in medication status (starting a new, additional, or different medication or changing the dose of a current medication) * Unstable or diagnosed chronic clinical disease, including cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological disease (e.g., hypertension, heart disease, diabetes, hyperlipidemia, psoriasis) * Body mass index \<18.5 or \>35 kg/m2 * Pregnancy (including a positive urine pregnancy test) or breast-feeding * Known allergies to pharmacological agents or study drugs * Non-English-speaking. Participants need to understand English to follow instructions and comply with procedures conducted during the screening and experimental visits.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06499844 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 30 Years, studying Endothelial Function. 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 NCT06499844 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06499844 currently recruiting?
Yes, NCT06499844 is actively recruiting participants. Contact the research team at anna-stanhewicz@uiowa.edu for enrollment information.
Where is the NCT06499844 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT06499844 clinical trial?
NCT06499844 is sponsored by University of Iowa. The trial plans to enroll 56 participants.