Back to results

AVACEN Hand Heating on Fasting Blood Glucose

Primary Purpose

Hyperglycemia, Hypertension

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

AVACEN 100

AVACEN 100 Heat Only

AVACEN Sham

About this trial

This is an interventional treatment trial for Hyperglycemia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy subjects

Exclusion Criteria:

Diabetes diagnosis, diabetes medication, blood pressure medication

Sites / Locations

San Diego State University

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 device applies heat and vacuum to hand

AVACEN 100 device with heat only

AVACEN 100 device with neither heat nor vacuum

Outcomes

Primary Outcome Measures

Fasting Blood Glucose

Change in fasting blood glucose after 30 minutes of use of AVACEN device

Secondary Outcome Measures

Blood Pressure

Change in blood pressure after 30 minutes of use of AVACEN device

Tympanic Temperature

Change in tympanic temperature after 30 minutes of use of AVACEN device

ASHRAE 7 point thermal sensation scale

Change in subjective temperature after 30 minutes of use of AVACEN device

Full Information

NCT ID

NCT04018586

First Posted

July 6, 2019

Last Updated

October 26, 2019

Sponsor

Jeff Moore

1. Study Identification

Unique Protocol Identification Number

NCT04018586

Brief Title

AVACEN Hand Heating on Fasting Blood Glucose

Official Title

AVACEN Treatment Method on Fasting and Postprandial Blood Glucose

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

February 28, 2019 (Actual)

Primary Completion Date

September 15, 2019 (Actual)

Study Completion Date

September 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jeff Moore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperglycemia, Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Heat and Vacuum

Arm Type

Experimental

Arm Description

AVACEN 100 device applies heat and vacuum to hand

Arm Title

Heat Only

Arm Type

Active Comparator

Arm Description

AVACEN 100 device with heat only

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

AVACEN 100 device with neither heat nor vacuum

Intervention Type

Device

Intervention Name(s)

AVACEN 100

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

AVACEN 100 Heat Only

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

AVACEN Sham

Intervention Description

AVACEN 100 neither heats nor pulls a vacuum to hand

Primary Outcome Measure Information:

Title

Fasting Blood Glucose

Description

Change in fasting blood glucose after 30 minutes of use of AVACEN device

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

Blood Pressure

Description

Change in blood pressure after 30 minutes of use of AVACEN device

Time Frame

30 minutes

Title

Tympanic Temperature

Description

Change in tympanic temperature after 30 minutes of use of AVACEN device

Time Frame

30 minutes

Title

ASHRAE 7 point thermal sensation scale

Description

Change in subjective temperature after 30 minutes of use of AVACEN device

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

Eligibility Criteria

Inclusion Criteria: Healthy subjects Exclusion Criteria: Diabetes diagnosis, diabetes medication, blood pressure medication

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeff M Moore, B.S./B.S.

Organizational Affiliation

Graduate Student

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Diego State University

City

San Diego

State/Province

California

ZIP/Postal Code

92182

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

AVACEN Hand Heating on Fasting Blood Glucose

We'll reach out to this number within 24 hrs