Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acetylcholine.
- Who it may be relevant to
- Registry conditions: Endothelial Function. Basic parameters: 18 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug 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 measures
- 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)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Iowa — Iowa City
Identifiers
NCT: NCT06499844 · 202404816