Hyperglycemia, Hypertension
Conditions
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.
Interventions
DEVICEAVACEN 100
AVACEN 100 pulls a -30mmHg vacuum around hand from wrist down and applies heat (108 farenheit) to the palm and will be applied for 30 minutes
DEVICEAVACEN 100 Heat Only
AVACEN 100 applies heat (108 Fahrenheit) to the palm and will be applied for 30 minutes
DEVICEAVACEN Sham
AVACEN 100 neither heats nor pulls a vacuum to hand
Sponsors
Jeff Moore
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects
Exclusion criteria
* Diabetes diagnosis, diabetes medication, blood pressure medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Blood Glucose | 30 minutes | Change in fasting blood glucose after 30 minutes of use of AVACEN device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 30 minutes | Change in blood pressure after 30 minutes of use of AVACEN device |
| Tympanic Temperature | 30 minutes | Change in tympanic temperature after 30 minutes of use of AVACEN device |
| ASHRAE 7 point thermal sensation scale | 30 minutes | Change in subjective temperature after 30 minutes of use of AVACEN device |
Countries
United States
Outcome results
None listed