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临床试验/NCT04436731
NCT04436731已完成1 期

Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2020年12月9日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
73
试验地点
1
主要终点
Change in forearm vascular conductance with intra-arterial drug infusion

研究概览

简要总结

Patients with sleep apnea are at increased risk of developing cardiovascular disease - with women at potentially greater risk than men. Contributing mechanisms are not well understood, but may be related to how women respond to low oxygen and, given over 70% of patients with sleep apnea are obese, the impact of obesity. This project seeks to increase our understanding of mechanisms that may contribute to sex differences in the cardiovascular response to low oxygen with the hope that this knowledge will improve the efficacy of current therapies and support the discovery of novel therapeutics.

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 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-45 years of age (premenopausal)
  • Healthy weight (BMI ≥18 and ≤25 kg/m2)
  • Obese (BMI ≥30 kg/m2)

排除标准

  • Pregnancy, breastfeeding, oral hormonal contraceptive use
  • Diagnosed sleep apnea or Oxygen desaturation index >10 events/hr
  • Current smoking/Nicotine use
  • Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
  • Nerve/neurologic disease
  • Cardiovascular, hepatic, renal, respiratory disease
  • Blood pressure ≥140/90 mmHg
  • Diabetes, Polycystic ovarian syndrome
  • Communication barriers
  • Prescription medications, Sensitivity to lidocaine

结局指标

主要结局

Change in forearm vascular conductance with intra-arterial drug infusion

时间窗: Continuous measurement of vascular conductance during infusion of each drug (final 3 min of normoxia and hypoxia).

Vascular conductance is an index of vascular tone and is measured using a technique called venous occlusion plethysmography.

Change in forearm vascular conductance with cold pressor test

时间窗: Continuous measurement of vascular conductance during cold pressor test (final 2 min of normoxia and hypoxia).

Vascular conductance is an index of vascular tone and is measured using a technique called venous occlusion plethysmography.

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

Jacqueline K Limberg, PhD

Associate Professor

University of Missouri-Columbia

研究点 (1)

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