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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heat and Vacuum | Experimental | AVACEN 100 device applies heat and vacuum to hand |
|
| Heat Only | Active Comparator | AVACEN 100 device with heat only |
|
| Sham | Sham Comparator | AVACEN 100 device with neither heat nor vacuum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVACEN 100 | Device | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Glucose | Change in fasting blood glucose after 30 minutes of use of AVACEN device | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Change in blood pressure after 30 minutes of use of AVACEN device | 30 minutes |
| Tympanic Temperature | Change in tympanic temperature after 30 minutes of use of AVACEN device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff M Moore, B.S./B.S. | Graduate Student | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego State University | San Diego | California | 92182 | United States |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
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| AVACEN 100 Heat Only | Device | AVACEN 100 applies heat (108 Fahrenheit) to the palm and will be applied for 30 minutes |
|
| AVACEN Sham | Device | AVACEN 100 neither heats nor pulls a vacuum to hand |
|
| 30 minutes |
| ASHRAE 7 point thermal sensation scale | Change in subjective temperature after 30 minutes of use of AVACEN device | 30 minutes |
| D002318 | Cardiovascular Diseases |