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临床试验/NCT06499844
NCT06499844招募中早期 1 期

Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation

University of Iowa1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
招募中
入组人数
56
试验地点
1
主要终点
Microvascular blood flow response to local heat (39 degrees Celsius)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • men and women
  • 18-30 years of age

排除标准

  • 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.

研究组 & 干预措施

assessment of microvascular endothelial function

Experimental

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

干预措施: Acetylcholine (Drug)

结局指标

主要结局

Microvascular blood flow response to local heat (39 degrees Celsius)

时间窗: 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.

Microvascular blood flow response to local heat (42 degrees Celsius)

时间窗: 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 acetylcholine

时间窗: baseline 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Stanhewicz, PhD

Assistant Professor

University of Iowa

研究点 (1)

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