Glucose ToleranceNCT05300256
Peripheral Heating and Glucose Tolerance
A study testing Peripheral Heating in people with Glucose Tolerance, run by San Diego State University at 1 site in United States.
Trial summary
Effect of peripheral heating on glucose tolerance Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Tolerance
- What is being tested?
- Peripheral Heating
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2022to 1 Dec 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-80 years
Who cannot join
- Open wounds on feet or legs
- Peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
San Diego State University
San Diego, California, 92182
Jeff Moore, 714-658-7215, Jmoore714@gmail.com
About this study
Effect of peripheral heating on glucose tolerance
- Conditions
- Glucose Tolerance
- Being tested
- Peripheral Heating, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral HeatingDevice
Peripheral heating of the feet
ShamDevice
Sham
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Heating | Experimental | Peripheral Heating Receives: Device: Peripheral Heating |
| Sham | Sham comparator | Sham Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose concentrations
Measured: 1 hour
Secondary outcomes (2)
Insulin concentrations
Measured: 1 hour
Blood flow
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start18 Mar 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose ToleranceStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Moore, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300256
- Sponsor's protocol ID
- PHTGLUCOSE
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Heating and Glucose Tolerance
- ClinicalTrials.gov ID
- NCT05300256
- Acronym / sponsor ID
- PHTGLUCOSE
- Conditions
- Glucose Tolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 29 Mar 2022 (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.
Effect of peripheral heating on glucose tolerance
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral Heating | Experimental | Device: Peripheral HeatingPeripheral Heating |
| Sham | Sham comparator | Device: ShamSham |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-80 years
Key exclusion criteria (2 listed)
- Open wounds on feet or legs
- Peripheral neuropathy
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 |
|---|---|---|
| Peripheral HeatingPeripheral heating of the feet | Device | Peripheral Heating |
| ShamSham | Device | Sham |
Primary outcome
Glucose concentrations
Time frame: 1 hour
2 secondary outcomes
Insulin concentrations
Time frame: 1 hour
Blood flow
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
Related trials for Glucose Tolerance
Not yet recruitingObservational study
Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring
End Stage Kidney Disease (ESKD), Hyperglycaemia
Not yet recruiting
A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
Postprandial Glucose, GI Tolerance
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
Recruiting
Can Food Timing Reduce Your Diabetes Risk?
Dietary Habits
Enrolling by invitation
Glycemic Impact of NNS Via the Gut Microbiome
Prediabetes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral Heating in people with Glucose Tolerance, 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 2 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeff Moore (7146587215, Jmoore714@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose concentrations (time frame: 1 hour). 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 30 Apr 2024.