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AVACEN Hand Heating on Fasting Blood Glucose

NCT04018586 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-10-29

No results posted yet for this study

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.

Conditions

Interventions

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

DEVICE

AVACEN 100 Heat Only

AVACEN 100 applies heat (108 Fahrenheit) to the palm and will be applied for 30 minutes

DEVICE

AVACEN Sham

AVACEN 100 neither heats nor pulls a vacuum to hand

Sponsors & Collaborators

  • Jeff Moore

    lead OTHER

Principal Investigators

  • Jeff M Moore, B.S./B.S. · Graduate Student

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2019-09-15
Completion
2019-09-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04018586 on ClinicalTrials.gov