Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation (CAP NOVA)

University of Iowa

Status and phase

Enrolling

Early Phase 1

Conditions

Endothelial Function

Treatments

Drug: Acetylcholine

Study type

Interventional

Funder types

Other

Identifiers

NCT06499844

202404816

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.