Skip to main content
OpenTrials
Completed

NCT Number: NCT04018976

AVACEN Treatment Method and Postprandial Blood Glucose

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jeff Moore

San Diego, California, 92182, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy individuals

Exclusion criteria

  • Diagnosis of diabetes, diabetes medication, hypertension medication

Treatment and study plan

AVACEN 100

Device

The AVACEN 100 pulls a -30mmHg vacuum around the hand from the wrist down and applies heat (108 Fahrenheit) to the palm

AVACEN 100 heat only

Device

The AVACEN 100 applies heat (108 Fahrenheit) to the palm

AVACEN 100 sham

Device

The AVACEN 100 does not provide heat or vacuum

Primary outcomes

  1. Postprandial Blood Glucose

    Time frame: 30 minutes

    Measuring peak postprandial blood glucose with Contour Next glucometer

Secondary outcomes

  1. Blood Pressure

    Time frame: 30 minutes

    Measuring blood pressure with automated cuff

  2. Tympanic Temperature

    Time frame: 30 minutes

    Measuring tympanic temperature with infrared thermometer

  3. ASHRAE 7 point thermal sensation scale

    Time frame: 30 minutes

    Measuring subjective temperature with thermal sensation scale

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 15, 2019
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.