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临床试验/NCT05206227
NCT05206227进行中(未招募)早期 1 期

Histamine as a Molecular Transducer of Adaptation to Exercise

University of Oregon1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年7月28日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
进行中(未招募)
入组人数
80
试验地点
1
主要终点
Histamine concentration

研究概览

简要总结

This study is investigating the role of histamine in generating adaptation to exercise

详细描述

Exercise promotes and maintains healthy cardiovascular, musculoskeletal, and metabolic function, but the signals and mechanisms which transduce these effects are poorly understood. Histamine plays a role in some of the positive benefits of exercise. The goal of this study is to determine the factors that regulate exercise's effects on endothelial and vascular function, with a focus on histamine released from mast cells in skeletal muscle. Participants will perform exercise or participate in interventions like heating that may replicate some of the effects of exercise. During most experiments, investigators will insert an intravenous catheter in an arm vein and microdialysis probes in the leg, collect dialysate from the microdialysis probe and blood from the vein, record noninvasive measures, and have the participants perform exercise or undergo heating.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 -40

排除标准

  • Systolic ≥ 120
  • Diastolic ≥ 80
  • Body mass index (BMI) ˃ 28 kg/m2
  • Prior diagnosis of cardiovascular disease, diabetes, autonomic disorders, or asthma
  • Smoking or nicotine use
  • Ongoing medical therapy (other than birth control)
  • Ongoing use of over-the-counter or prescription antihistamines
  • Allergies or hypersensitivities to drugs, local anesthetics, skin disinfectants, adhesives, or latex
  • Pregnant, breastfeeding subjects, or planning to become pregnant in the next 12 months
  • Mobility restrictions that interfere with physical activity
  • High physical activity based on International Physical Activity Questionaire (IPAQ1)
  • Non-English speaking

研究组 & 干预措施

Aerobic Exercise

Experimental

Blood and skeletal muscle microdialysate collected during dynamic knee-extension exercise

干预措施: Aerobic Exercise (Behavioral)

Heating

Experimental

Blood and skeletal muscle microdialysate collected during local and/or whole body heating

干预措施: alpha-FMH (Drug)

Resistance and Aerobic Exercise

Experimental

Blood and urine collected during recovery from two modalities of exercise (This arm is now CLOSED)

干预措施: Resistance and Aerobic Exercise (Behavioral)

Aerobic Exercise and Muscle Perfusion

Experimental

Muscle perfusion measured during aerobic exercise (This arm is now CLOSED)

干预措施: Aerobic Exercise (Behavioral)

Aerobic Exercise and Muscle Perfusion

Experimental

Muscle perfusion measured during aerobic exercise (This arm is now CLOSED)

干预措施: Antihistamine (Drug)

结局指标

主要结局

Histamine concentration

时间窗: One hour

Histamine concentration in intramuscular dialysate

Histamine metabolites

时间窗: 24 hours

Concentration of histamine metabolites in blood and urine

Percentage of mast cell degranulation

时间窗: One hour

Beta-hexosaminidase release from mast cells in mast cell degranulation bioassay when exposed to intramuscular dialysate from exercising individuals

Muscle perfusion

时间窗: One hour

Skeletal muscle tissue oxygen index

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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