AVACEN Treatment Method and Postprandial Blood Glucose
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 5, 2019
CompletedFirst Submitted
Initial submission to the registry
July 6, 2019
CompletedFirst Posted
Study publicly available on registry
July 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2019
CompletedOctober 29, 2019
October 1, 2019
4 months
July 6, 2019
October 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Postprandial Blood Glucose
Measuring peak postprandial blood glucose with Contour Next glucometer
30 minutes
Secondary Outcomes (3)
Blood Pressure
30 minutes
Tympanic Temperature
30 minutes
ASHRAE 7 point thermal sensation scale
30 minutes
Study Arms (3)
Heat and Vacuum
EXPERIMENTALAVACEN 100 applies heat and vacuum to hand
Heat Only
ACTIVE COMPARATORAVACEN 100 applies heat only
Sham
SHAM COMPARATORAVACEN 100 applies neither heat nor vacuum
Interventions
The AVACEN 100 pulls a -30mmHg vacuum around the hand from the wrist down and applies heat (108 Fahrenheit) to the palm
Eligibility Criteria
You may qualify if:
- Healthy individuals
You may not qualify if:
- Diagnosis of diabetes, diabetes medication, hypertension medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jeff Moore
San Diego, California, 92182, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeff M Moore, B.S./B.S.
San Diego State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
July 6, 2019
First Posted
July 15, 2019
Study Start
May 5, 2019
Primary Completion
September 15, 2019
Study Completion
September 15, 2019
Last Updated
October 29, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share