AVACEN Hand Heating on Fasting Blood Glucose

AVACEN Treatment Method on Fasting and Postprandial Blood Glucose

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Hypertension
• Intervention / Treatment: Device: AVACEN 100; Device: AVACEN 100 Heat Only; Device: AVACEN Sham

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92182
      • San Diego State University

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 subjects

Exclusion Criteria:

• Diabetes diagnosis, diabetes medication, blood pressure 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 device applies heat and vacuum to hand	Device: AVACEN 100; 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
Active Comparator: Heat Only; AVACEN 100 device with heat only	Device: AVACEN 100 Heat Only; AVACEN 100 applies heat (108 Fahrenheit) to the palm and will be applied for 30 minutes
Sham Comparator: Sham; AVACEN 100 device with neither heat nor vacuum	Device: AVACEN Sham; AVACEN 100 neither heats nor pulls a vacuum to hand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Blood Glucose	Change in fasting blood glucose after 30 minutes of use of AVACEN device	30 minutes

Secondary Outcome Measures

Outcome Measure	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	30 minutes
ASHRAE 7 point thermal sensation scale	Change in subjective temperature after 30 minutes of use of AVACEN device	30 minutes

Collaborators and Investigators

• Sponsor: Jeff Moore
• Investigators: Principal Investigator: Jeff M Moore, B.S./B.S., graduate student

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 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 12, 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: AVACENFBG

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