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AVACEN Hand Heating on Fasting Blood Glucose

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ClinicalTrials.gov Identifier: NCT04018586
Recruitment Status : Active, not recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Jeff Moore, San Diego State University

Brief 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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Hypertension Device: AVACEN 100 Device: AVACEN 100 Heat Only Device: AVACEN Sham Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: AVACEN Treatment Method on Fasting and Postprandial Blood Glucose
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: Heat and Vacuum
AVACEN 100 device applies heat and vacuum to hand
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

Active Comparator: Heat Only
AVACEN 100 device with heat only
Device: AVACEN 100 Heat Only
AVACEN 100 applies heat (108 Fahrenheit) to the palm and will be applied for 30 minutes

Sham Comparator: Sham
AVACEN 100 device with neither heat nor vacuum
Device: AVACEN Sham
AVACEN 100 neither heats nor pulls a vacuum to hand




Primary Outcome Measures :
  1. Fasting Blood Glucose [ Time Frame: 30 minutes ]
    Change in fasting blood glucose after 30 minutes of use of AVACEN device


Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: 30 minutes ]
    Change in blood pressure after 30 minutes of use of AVACEN device

  2. Tympanic Temperature [ Time Frame: 30 minutes ]
    Change in tympanic temperature after 30 minutes of use of AVACEN device

  3. ASHRAE 7 point thermal sensation scale [ Time Frame: 30 minutes ]
    Change in subjective temperature after 30 minutes of use of AVACEN device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Diabetes diagnosis, diabetes medication, blood pressure medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018586


Locations
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United States, California
San Diego State University
San Diego, California, United States, 92182
Sponsors and Collaborators
Jeff Moore
Investigators
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Principal Investigator: Jeff M Moore, B.S./B.S. Graduate Student

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Responsible Party: Jeff Moore, Investigator, San Diego State University
ClinicalTrials.gov Identifier: NCT04018586     History of Changes
Other Study ID Numbers: AVACENFBG
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases