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临床试验/NCT04018976
NCT04018976已完成不适用

AVACEN Treatment Method and Postprandial Blood Glucose

San Diego State University2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年5月5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
入组人数
13
试验地点
2
主要终点
Postprandial 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 postprandial 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 will use each of these three devices during the first hour of a 2-hour oral glucose tolerance test 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 2-hour oral glucose tolerance test.

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 individuals

排除标准

  • Diagnosis of diabetes, diabetes medication, hypertension medication

研究组 & 干预措施

Heat and Vacuum

Experimental

AVACEN 100 applies heat and vacuum to hand

干预措施: AVACEN 100 (Device)

Heat Only

Active Comparator

AVACEN 100 applies heat only

干预措施: AVACEN 100 heat only (Device)

Sham

Sham Comparator

AVACEN 100 applies neither heat nor vacuum

干预措施: AVACEN 100 sham (Device)

结局指标

主要结局

Postprandial Blood Glucose

时间窗: 30 minutes

Measuring peak postprandial blood glucose with Contour Next glucometer

次要结局

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

研究者

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

Jeff Moore

Investigator

San Diego State University

研究点 (2)

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