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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heat and Vacuum | Experimental | AVACEN 100 applies heat and vacuum to hand |
|
| Heat Only | Active Comparator | AVACEN 100 applies heat only |
|
| Sham | Sham Comparator | AVACEN 100 applies neither heat nor vacuum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Blood Glucose | Measuring peak postprandial blood glucose with Contour Next glucometer | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Measuring blood pressure with automated cuff | 30 minutes |
| Tympanic Temperature | Measuring tympanic temperature with infrared thermometer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff M Moore, B.S./B.S. | San Diego State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeff Moore | San Diego | California | 92182 | United States |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
|
| 30 minutes |
| ASHRAE 7 point thermal sensation scale | Measuring subjective temperature with thermal sensation scale | 30 minutes |