AVACEN Treatment Method and Postprandial Blood Glucose

San Diego State University

Status: Completed

Conditions: Postprandial Hyperglycemia

Treatments: Device: AVACEN 100; Device: AVACEN 100 sham; Device: AVACEN 100 heat only

Study type: Interventional

Funder types: Other

Identifiers

NCT04018976

AVACENOGTT

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy individuals

Exclusion criteria

• Diagnosis of diabetes, diabetes medication, hypertension medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 3 patient groups

Heat and Vacuum

Experimental group

Description:

AVACEN 100 applies heat and vacuum to hand

Treatment:

Device: AVACEN 100

Heat Only

Active Comparator group

Description:

AVACEN 100 applies heat only

Treatment:

Device: AVACEN 100 heat only

Sham

Sham Comparator group

Description:

AVACEN 100 applies neither heat nor vacuum

Treatment:

Device: AVACEN 100 sham