Back to resultsAVACEN Treatment Method and Postprandial Blood Glucose
Primary Purpose
Postprandial Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AVACEN 100
AVACEN 100 heat only
AVACEN 100 sham
Sponsored by
About this trial
This is an interventional treatment trial for Postprandial Hyperglycemia
Eligibility Criteria
Inclusion Criteria:
- Healthy individuals
Exclusion Criteria:
- Diagnosis of diabetes, diabetes medication, hypertension medication
Sites / Locations
- Jeff Moore
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Heat and Vacuum
Heat Only
Sham
Arm Description
AVACEN 100 applies heat and vacuum to hand
AVACEN 100 applies heat only
AVACEN 100 applies neither heat nor vacuum
Outcomes
Primary Outcome Measures
Postprandial Blood Glucose
Measuring peak postprandial blood glucose with Contour Next glucometer
Secondary Outcome Measures
Blood Pressure
Measuring blood pressure with automated cuff
Tympanic Temperature
Measuring tympanic temperature with infrared thermometer
ASHRAE 7 point thermal sensation scale
Measuring subjective temperature with thermal sensation scale
Full Information
NCT ID
NCT04018976
First Posted
July 6, 2019
Last Updated
October 26, 2019
Sponsor
San Diego State University
1. Study Identification
Unique Protocol Identification Number
NCT04018976
Brief Title
AVACEN Treatment Method and Postprandial Blood Glucose
Official Title
AVACEN Treatment Method and Postprandial Blood Glucose
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 5, 2019 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
September 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heat and Vacuum
Arm Type
Experimental
Arm Description
AVACEN 100 applies heat and vacuum to hand
Arm Title
Heat Only
Arm Type
Active Comparator
Arm Description
AVACEN 100 applies heat only
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
AVACEN 100 applies neither heat nor vacuum
Intervention Type
Device
Intervention Name(s)
AVACEN 100
Intervention Description
The AVACEN 100 pulls a -30mmHg vacuum around the hand from the wrist down and applies heat (108 Fahrenheit) to the palm
Intervention Type
Device
Intervention Name(s)
AVACEN 100 heat only
Intervention Description
The AVACEN 100 applies heat (108 Fahrenheit) to the palm
Intervention Type
Device
Intervention Name(s)
AVACEN 100 sham
Intervention Description
The AVACEN 100 does not provide heat or vacuum
Primary Outcome Measure Information:
Title
Postprandial Blood Glucose
Description
Measuring peak postprandial blood glucose with Contour Next glucometer
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Measuring blood pressure with automated cuff
Time Frame
30 minutes
Title
Tympanic Temperature
Description
Measuring tympanic temperature with infrared thermometer
Time Frame
30 minutes
Title
ASHRAE 7 point thermal sensation scale
Description
Measuring subjective temperature with thermal sensation scale
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy individuals
Exclusion Criteria:
Diagnosis of diabetes, diabetes medication, hypertension medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff M Moore, B.S./B.S.
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jeff Moore
City
San Diego
State/Province
California
ZIP/Postal Code
92182
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
AVACEN Treatment Method and Postprandial Blood Glucose
We'll reach out to this number within 24 hrs