Postprandial HyperglycemiaNCT04018976
AVACEN Treatment Method and Postprandial Blood Glucose
A study testing AVACEN 100 and AVACEN 100 heat only in people with Postprandial Hyperglycemia, run by San Diego State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia
- What is being tested?
- AVACEN 100 and AVACEN 100 heat only
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2019to 15 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals
Who cannot join
- Diagnosis of diabetes, diabetes medication, hypertension medication
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Postprandial Hyperglycemia
- Being tested
- AVACEN 100, AVACEN 100 heat only, AVACEN 100 sham
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVACEN 100Device
The AVACEN 100 pulls a -30mmHg vacuum around the hand from the wrist down and applies heat (108 Fahrenheit) to the palm
AVACEN 100 heat onlyDevice
The AVACEN 100 applies heat (108 Fahrenheit) to the palm
AVACEN 100 shamDevice
The AVACEN 100 does not provide heat or vacuum
| Study group | Role | What they receive |
|---|---|---|
| Heat and Vacuum | Experimental | AVACEN 100 applies heat and vacuum to hand Receives: Device: AVACEN 100 |
| Heat Only | Active comparator | AVACEN 100 applies heat only Receives: Device: AVACEN 100 heat only |
| Sham | Sham comparator | AVACEN 100 applies neither heat nor vacuum Receives: Device: AVACEN 100 sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Blood Glucose
Measuring peak postprandial blood glucose with Contour Next glucometer
Measured: 30 minutes
Secondary outcomes (3)
Blood Pressure
Measuring blood pressure with automated cuff
Measured: 30 minutes
Tympanic Temperature
Measuring tympanic temperature with infrared thermometer
Measured: 30 minutes
ASHRAE 7 point thermal sensation scale
Measuring subjective temperature with thermal sensation scale
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start5 May 2019
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Moore, San Diego State University
- Investigators
- Jeff M Moore, B.S./B.S., Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018976
- Sponsor's protocol ID
- AVACENOGTT
- Status last verified
- Oct 2019
- First submitted
- 6 Jul 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVACEN Treatment Method and Postprandial Blood Glucose
- ClinicalTrials.gov ID
- NCT04018976
- Acronym / sponsor ID
- AVACENOGTT
- Conditions
- Postprandial Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 5 May 2019 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heat and Vacuum | Experimental | Device: AVACEN 100AVACEN 100 applies heat and vacuum to hand |
| Heat Only | Active comparator | Device: AVACEN 100 heat onlyAVACEN 100 applies heat only |
| Sham | Sham comparator | Device: AVACEN 100 shamAVACEN 100 applies neither heat nor vacuum |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy individuals
Key exclusion criteria (1 listed)
- Diagnosis of diabetes, diabetes medication, hypertension medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVACEN 100The AVACEN 100 pulls a -30mmHg vacuum around the hand from the wrist down and applies heat (108 Fahrenheit) to the palm | Device | Heat and Vacuum |
| AVACEN 100 heat onlyThe AVACEN 100 applies heat (108 Fahrenheit) to the palm | Device | Heat Only |
| AVACEN 100 shamThe AVACEN 100 does not provide heat or vacuum | Device | Sham |
Primary outcome
Postprandial Blood Glucose
Time frame: 30 minutes
Measuring peak postprandial blood glucose with Contour Next glucometer
3 secondary outcomes
Blood Pressure
Time frame: 30 minutes
Tympanic Temperature
Time frame: 30 minutes
ASHRAE 7 point thermal sensation scale
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff M Moore, B.S./B.S. principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVACEN 100 and AVACEN 100 heat only in people with Postprandial Hyperglycemia, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Blood Glucose (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.