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临床试验/NCT04018586
NCT04018586已完成不适用

AVACEN Treatment Method on Fasting and Postprandial Blood Glucose

Jeff Moore2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2019年2月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
2
主要终点
Fasting Blood Glucose

研究概览

简要总结

A double-blind crossover randomized controlled trial to investigate the effects of the AVACEN device on fasting blood glucose. The AVACEN device creates negative pressure around the hand while heating the palm. Two sham devices, one providing heat but no vacuum and one providing neither heat nor vacuum were also used. Each subject was tested while using each of these three devices on separate visits. Subjects arrived in the morning following an overnight fast. Fasting blood glucose, blood pressure, tympanic temperature, and subjective thermal ratings were measured before and throughout the 30 minutes that the device was used.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

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

  • Healthy subjects

排除标准

  • Diabetes diagnosis, diabetes medication, blood pressure medication

研究组 & 干预措施

Heat and Vacuum

Experimental

AVACEN 100 device applies heat and vacuum to hand

干预措施: AVACEN 100 (Device)

Heat Only

Active Comparator

AVACEN 100 device with heat only

干预措施: AVACEN 100 Heat Only (Device)

Sham

Sham Comparator

AVACEN 100 device with neither heat nor vacuum

干预措施: AVACEN Sham (Device)

结局指标

主要结局

Fasting Blood Glucose

时间窗: 30 minutes

Change in fasting blood glucose after 30 minutes of use of AVACEN device

次要结局

  • Blood Pressure(30 minutes)
  • Tympanic Temperature(30 minutes)
  • ASHRAE 7 point thermal sensation scale(30 minutes)

研究者

发起方
Jeff Moore
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jeff Moore

Investigator

San Diego State University

研究点 (2)

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