Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation

NCT ID: NCT06499844

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-09-30

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.

Conditions

Endothelial Function

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

assessment of microvascular endothelial function

The investigators use intradermal microdialysis to deliver acetylcholine, L-NAME, and acetylcholine + L-NAME to the cutaneous microvasculature.

Group Type: EXPERIMENTAL

Acetylcholine

Intervention Type: DRUG

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

Interventions

Acetylcholine

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Anna Stanhewicz, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Iowa

Iowa City, Iowa, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anna Stanhewicz, PhD

Role: CONTACT

anna-stanhewicz@uiowa.edu

3194671732

Facility Contacts

Anna Stanhewicz, PhD

Role: primary

anna-stanhewicz@uiowa.edu

319-467-1732

Other Identifiers

202404816

Identifier Type: -

Identifier Source: org_study_id