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NCT04018586 Clinical Trial

AVACEN Hand Heating on Fasting Blood Glucose

Hypertension Clinical Trial

Official title:
AVACEN Treatment Method on Fasting and Postprandial Blood Glucose

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04018586
Other study ID # AVACENFBG
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 28, 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
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 17
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 subjects

Exclusion Criteria:

- Diabetes diagnosis, diabetes medication, blood pressure medication

Study Design

Related Conditions & MeSH terms

Intervention

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
• AVACEN 100 Heat Only
AVACEN 100 applies heat (108 Fahrenheit) to the palm and will be applied for 30 minutes
• AVACEN Sham
AVACEN 100 neither heats nor pulls a vacuum to hand

Locations
Country Name City State
United States San Diego State University San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Jeff Moore

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fasting Blood Glucose Change in fasting blood glucose after 30 minutes of use of AVACEN device 30 minutes
Secondary Blood Pressure Change in blood pressure after 30 minutes of use of AVACEN device 30 minutes
Secondary Tympanic Temperature Change in tympanic temperature after 30 minutes of use of AVACEN device 30 minutes
Secondary ASHRAE 7 point thermal sensation scale Change in subjective temperature after 30 minutes of use of AVACEN device 30 minutes
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