AVACEN Hand Heating on Fasting Blood Glucose

Jeff Moore

Status: Completed

Conditions: Hypertension; Hyperglycemia

Treatments: Device: AVACEN Sham; Device: AVACEN 100; Device: AVACEN 100 Heat Only

Study type: Interventional

Funder types: Other

Identifiers

NCT04018586

AVACENFBG

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects

Exclusion criteria

• Diabetes diagnosis, diabetes medication, blood pressure medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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17 participants in 3 patient groups

Heat and Vacuum

Experimental group

Description:

AVACEN 100 device applies heat and vacuum to hand

Treatment:

Device: AVACEN 100

Heat Only

Active Comparator group

Description:

AVACEN 100 device with heat only

Treatment:

Device: AVACEN 100 Heat Only

Sham

Sham Comparator group

Description:

AVACEN 100 device with neither heat nor vacuum

Treatment:

Device: AVACEN Sham