Recruiting
Early Phase 1

Observational Study

Sponsor:

University of Iowa

Code:

NCT06499844

Conditions

Endothelial Function

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

Acetylcholine

Study Details

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 ID

NCT06499844

Start date

Aug 1, 2024

Status verified date

Aug, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Aug 12, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

56 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: assessment of microvascular endothelial function

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

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

Primary outcome measure

  • Microvascular blood flow response to acetylcholine [ Time Frame: baseline study visit (average of 4 hours) ]
  • Microvascular blood flow response to local heat (42 degrees Celsius) [ Time Frame: baseline study visit (average of 4 hours) ]
  • Microvascular blood flow response to local heat (39 degrees Celsius) [ Time Frame: baseline study visit (average of 4 hours) ]

Central Contacts and Locations

Central contacts

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

More Information

Sponsor

University of Iowa

Last update posted

Aug 24, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Iowa on 2025-08-24.