AVACEN Treatment Method on Fasting and Postprandial Blood Glucose
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Fasting Blood Glucose
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy subjects
Exclusion Criteria
- •Diabetes diagnosis, diabetes medication, blood pressure medication
Arms & Interventions
Heat and Vacuum
AVACEN 100 device applies heat and vacuum to hand
Intervention: AVACEN 100 (Device)
Heat Only
AVACEN 100 device with heat only
Intervention: AVACEN 100 Heat Only (Device)
Sham
AVACEN 100 device with neither heat nor vacuum
Intervention: AVACEN Sham (Device)
Outcomes
Primary Outcomes
Fasting Blood Glucose
Time Frame: 30 minutes
Change in fasting blood glucose after 30 minutes of use of AVACEN device
Secondary Outcomes
- Blood Pressure(30 minutes)
- Tympanic Temperature(30 minutes)
- ASHRAE 7 point thermal sensation scale(30 minutes)
Investigators
Jeff Moore
Investigator
San Diego State University