NCT04018976

AVACEN Treatment Method and Postprandial Blood Glucose

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: San Diego State University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postprandial Hyperglycemia

Interventions

Type	Name	Description
DEVICE	AVACEN 100	The AVACEN 100 pulls a -30mmHg vacuum around the hand from the wrist down and applies heat (108 Fahrenheit) to the palm
DEVICE	AVACEN 100 heat only	The AVACEN 100 applies heat (108 Fahrenheit) to the palm
DEVICE	AVACEN 100 sham	The AVACEN 100 does not provide heat or vacuum

Timeline

• Start date: 2019-05-05
• Primary completion: 2019-09-15
• Completion: 2019-09-15
• First posted: 2019-07-15
• Last updated: 2019-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study