AVACEN Treatment Method and Postprandial Blood Glucose

Postprandial Hyperglycemia Clinical Trial

Official title:

AVACEN Treatment Method and Postprandial Blood Glucose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018976
• Other study ID #: AVACENOGTT
• Status: Completed
• Phase: N/A
• Start date: May 5, 2019
• Est. completion date: September 15, 2019

Study information

• Verified date: October 2019
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 15, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy individuals

Exclusion Criteria:

• Diagnosis of diabetes, diabetes medication, hypertension medication

Related Conditions & MeSH terms

• Hyperglycemia
• Postprandial Hyperglycemia

Intervention

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
• AVACEN 100 heat only
The AVACEN 100 applies heat (108 Fahrenheit) to the palm
• AVACEN 100 sham
The AVACEN 100 does not provide heat or vacuum

Locations

Country	Name	City	State
United States	Jeff Moore	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial Blood Glucose	Measuring peak postprandial blood glucose with Contour Next glucometer	30 minutes
Secondary	Blood Pressure	Measuring blood pressure with automated cuff	30 minutes
Secondary	Tympanic Temperature	Measuring tympanic temperature with infrared thermometer	30 minutes
Secondary	ASHRAE 7 point thermal sensation scale	Measuring subjective temperature with thermal sensation scale	30 minutes