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OpenTrials
Completed

NCT Number: NCT04018586

AVACEN Hand Heating on Fasting Blood Glucose

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.

Completed

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Key information

Conditions

Hyperglycemia Cardiovascular Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University

San Diego, California, 92182, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects

Exclusion criteria

  • Diabetes diagnosis, diabetes medication, blood pressure medication

Treatment and study plan

AVACEN 100

Device

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

AVACEN 100 heat only

Device

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

AVACEN Sham

Device

AVACEN 100 neither heats nor pulls a vacuum to hand

Primary outcomes

  1. Fasting Blood Glucose

    Time frame: 30 minutes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Jeff Moore

Other

Registry information

Official study title

AVACEN Treatment Method on Fasting and Postprandial Blood Glucose

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2019
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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