Postprandial Hyperglycemia
Conditions
Brief summary
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.
Interventions
DEVICEAVACEN 100
The AVACEN 100 pulls a -30mmHg vacuum around the hand from the wrist down and applies heat (108 Fahrenheit) to the palm
DEVICEAVACEN 100 heat only
The AVACEN 100 applies heat (108 Fahrenheit) to the palm
DEVICEAVACEN 100 sham
The AVACEN 100 does not provide heat or vacuum
Sponsors
San Diego State University
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 individuals
Exclusion criteria
* Diagnosis of diabetes, diabetes medication, hypertension medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Blood Glucose | 30 minutes | Measuring peak postprandial blood glucose with Contour Next glucometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 30 minutes | Measuring blood pressure with automated cuff |
| Tympanic Temperature | 30 minutes | Measuring tympanic temperature with infrared thermometer |
| ASHRAE 7 point thermal sensation scale | 30 minutes | Measuring subjective temperature with thermal sensation scale |
Countries
United States
Outcome results
None listed