AVACEN Treatment Method and Postprandial Blood Glucose

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.

Study Overview

• Status: Completed
• Conditions: Postprandial Hyperglycemia
• Intervention / Treatment: Device: AVACEN 100; Device: AVACEN 100 heat only; Device: AVACEN 100 sham

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92182
      • Jeff Moore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy individuals

Exclusion Criteria:

• Diagnosis of diabetes, diabetes medication, hypertension medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heat and Vacuum; AVACEN 100 applies heat and vacuum to hand	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
Active Comparator: Heat Only; AVACEN 100 applies heat only	Device: AVACEN 100 heat only; The AVACEN 100 applies heat (108 Fahrenheit) to the palm
Sham Comparator: Sham; AVACEN 100 applies neither heat nor vacuum	Device: AVACEN 100 sham; The AVACEN 100 does not provide heat or vacuum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial Blood Glucose	Measuring peak postprandial blood glucose with Contour Next glucometer	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Measuring blood pressure with automated cuff	30 minutes
Tympanic Temperature	Measuring tympanic temperature with infrared thermometer	30 minutes
ASHRAE 7 point thermal sensation scale	Measuring subjective temperature with thermal sensation scale	30 minutes

Collaborators and Investigators

• Sponsor: San Diego State University
• Investigators: Principal Investigator: Jeff M Moore, B.S./B.S., San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2019
• Primary Completion (Actual): September 15, 2019
• Study Completion (Actual): September 15, 2019

Study Registration Dates

• First Submitted: July 6, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 26, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: AVACENOGTT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes