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Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation

Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06499844
Acronym
CAP NOVA
Enrollment
56
Registered
2024-07-15
Start date
2024-08-01
Completion date
2026-09-30
Last updated
2025-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Function

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.

Interventions

DRUGAcetylcholine

acetylcholine, and acetylcholine + L-NAME (Nitric oxide synthase inhibitor) are locally and acutely delivered to the cutaneous microvasculature to assess endothelium- and nitric oxide-dependent dilation

Sponsors

University of Iowa
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

All participants will complete one laboratory visit to assess endothelial function in the cutaneous microvasculature.

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Microvascular blood flow response to acetylcholinebaseline study visit (average of 4 hours)cutaneous vascular vasodilator response to exogenous acetylcholine perfusion; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of acetylcholine alone or co-infused with L-NAME
Microvascular blood flow response to local heat (42 degrees Celsius)baseline study visit (average of 4 hours)cutaneous vascular vasodilator response to 42 degree local heat; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of lactated Ringer's, followed by L-NAME.
Microvascular blood flow response to local heat (39 degrees Celsius)baseline study visit (average of 4 hours)cutaneous vascular vasodilator response to 39 degree local heat; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of lactated Ringer's, followed by L-NAME.

Countries

United States

Contacts

Primary ContactAnna Stanhewicz, PhD
anna-stanhewicz@uiowa.edu3194671732

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026